<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246413</url>
  </required_header>
  <id_info>
    <org_study_id>14-05-323</org_study_id>
    <secondary_id>R01HL119453</secondary_id>
    <secondary_id>UH2HL132368</secondary_id>
    <nct_id>NCT02246413</nct_id>
  </id_info>
  <brief_title>Research Aimed at Improving Both Mood and Weight</brief_title>
  <acronym>RAINBOW-ENGAGE</acronym>
  <official_title>RCT on Co-management of Obesity, Depression, and Elevated CVD Risk in Primary Care-- Engaging Self-regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sutter Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palo Alto Medical Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical&#xD;
      and cost effectiveness and implementation potential of a primary care integrated&#xD;
      multicondition intervention program to help improve mood and weight for obese adults with&#xD;
      clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation&#xD;
      added to the main trial with funding through the NIH common fund for the Science of Behavior&#xD;
      Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial&#xD;
      participants will be consented to undergo additional assays evaluating neurobiological&#xD;
      mechanisms of self-regulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The large numbers of primary care patients affected by coexisting obesity and depression and&#xD;
      common risk factors for diabetes and heart disease underscore the urgency of developing&#xD;
      effective, accessible, and sustainable interventions that use an integrated, multicondition&#xD;
      care management approach. The RAINBOW trial will rigorously evaluate the clinical and cost&#xD;
      effectiveness and potential for &quot;real-world&quot; implementation of an innovative intervention&#xD;
      that integrates a behavioral weight loss program and a collaborative stepped care program for&#xD;
      depression, incorporates conventional clinic- and home-based modes of care delivery (e.g.,&#xD;
      office visits plus phone consults and take-home DVD), and leverages low-cost, wide-reach&#xD;
      health information technologies (e.g., Web, secure email, and mobile texting). Beginning Jan&#xD;
      11, 2016, at least 100 of newly enrolled trial participants will also be consented to undergo&#xD;
      additional assays evaluating neurobiological mechanisms of self-regulation, including&#xD;
      emotional regulation, cognitive control and self-reflection. Given its focus on transforming&#xD;
      primary care management of obesity and depression and common cardiometabolic risk factors to&#xD;
      evidence-based, patient-centered care, as well as the likely scalability of the proposed&#xD;
      intervention, the study has high potential for significant clinical and public health impact.&#xD;
      Furthermore, elucidating the neurobiological mechanisms of self-regulation will significantly&#xD;
      advance precision lifestyle medicine by enabling mechanism-targeted individualization of&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Co-Primary Outcome: Body Mass Index (BMI)</measure>
    <time_frame>12 months</time_frame>
    <description>Integrated intervention treatment response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score</measure>
    <time_frame>12 months</time_frame>
    <description>Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>24 months</time_frame>
    <description>Derived from height and weight measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptom Checklist 20 (SCL-20) Score</measure>
    <time_frame>24 months</time_frame>
    <description>SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 months</time_frame>
    <description>Weight measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>24 months</time_frame>
    <description>Weight measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Remission (Number of Participants With SCL-20 Scores &lt;0.5)</measure>
    <time_frame>12 months</time_frame>
    <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Remission (Number of Participants With SCL-20 Score &lt;0.5)</measure>
    <time_frame>24 months</time_frame>
    <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</measure>
    <time_frame>12 months</time_frame>
    <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</measure>
    <time_frame>24 months</time_frame>
    <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</measure>
    <time_frame>12 months</time_frame>
    <description>5% or greater weight loss from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</measure>
    <time_frame>24 months</time_frame>
    <description>5% or greater weight loss from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 months</time_frame>
    <description>Average annual per person spending on medical care services (2018 real US dollars)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</measure>
    <time_frame>12 months</time_frame>
    <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety (GAD-7)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability (Sheehan Disability Scale)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Activity)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Pain)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance T-score</measure>
    <time_frame>12 months</time_frame>
    <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Impairment T-score</measure>
    <time_frame>12 months</time_frame>
    <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regulation of Cognition</measure>
    <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
    <description>Regulation of cognition is measured using lab-based fMRI. To measure regulation of cognition, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various cognitive control web-based tasks, and online questionnaires administered with REDCap (COPE Inventory for Cognitive Coping and Clutter Image Rating Scale). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regulation of Self-reflection</measure>
    <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
    <description>Regulation of cognition is measured using lab-based fMRI. To measure regulation of self-reflection, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, and online questionnaires administered with REDCap (BRISC Questionnaire of Emotional Resilience and Self-efficacy). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regulation of Emotion</measure>
    <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
    <description>Regulation of emotion is measured using lab-based fMRI. To measure regulation of emotion, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various emotional web-based tasks, and online questionnaires administered with REDCap (emotional regulation questionnaire, early life stress questionnaire, and emotional regulation ratings success and strategies). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</measure>
    <time_frame>24 months</time_frame>
    <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety (GAD-7)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability (Sheehan Disability Scale)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Activity)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Pain)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance T-score</measure>
    <time_frame>24 months</time_frame>
    <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Impairment T-score</measure>
    <time_frame>24 months</time_frame>
    <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure Time Physical Activity</measure>
    <time_frame>7-day Physical Activity Recall was administered at 12 months</time_frame>
    <description>Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Energy Expenditure</measure>
    <time_frame>7-day Physical Activity Recall was administered at 12 months</time_frame>
    <description>Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Calorie Intake</measure>
    <time_frame>One day's 24-hour dietary recall was administered at 12 months</time_frame>
    <description>Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASH (Dietary Approach to Stop Hypertension) Score</measure>
    <time_frame>One day's 24-hour dietary recall was administered at 12 months</time_frame>
    <description>Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">409</enrollment>
  <condition>Depression</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>RAINBOW Intervention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RAINBOW Intervention Program</intervention_name>
    <description>Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
    <arm_group_label>RAINBOW Intervention Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        RAINBOW&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Ethnicity and race: Any;&#xD;
&#xD;
          -  Obesity: BMI≥30 kg/m2 for non-Asians; BMI≥27 kg/m2 for Asians;&#xD;
&#xD;
          -  Clinically significant depressive symptoms: PHQ-9≥10;&#xD;
&#xD;
          -  A PAMF patient for ≥1 year&#xD;
&#xD;
          -  Seen in primary care at least once in the preceding 24 months;&#xD;
&#xD;
          -  Able and willing to enroll and meet the requirements of the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Inability to speak, read or understand English;&#xD;
&#xD;
          -  Having no reliable telephone service, no device to use to watch a DVD, or no regular&#xD;
             Internet access via a computer and/or mobile device;&#xD;
&#xD;
          -  Had bariatric surgery within the past 12 months or plans to undergo bariatric surgery&#xD;
             during the 24-month study period;&#xD;
&#xD;
          -  Ongoing psychiatric care outside of the PAMF network.&#xD;
&#xD;
          -  Active suicidal ideation that includes active plan and/or intent;&#xD;
&#xD;
          -  Any Axis I disorder other than Minor or Major Depressive Disorder and/or Dysthymia,&#xD;
             with the exception of any comorbid Anxiety Disorder;&#xD;
&#xD;
          -  Active Bulimia Nervosa within the past 12 months (however Binge Eating Disorder&#xD;
             without purging is not an exclusionary condition);&#xD;
&#xD;
          -  Active alcohol or substance use disorder (including prescription drugs).&#xD;
&#xD;
          -  Pre-existing diabetes (other than during pregnancy) or diabetes diagnosed as a result&#xD;
             of fasting blood glucose or hemoglobin A1c levels obtained through study screening;&#xD;
&#xD;
          -  Pre-existing cardiovascular disease.&#xD;
&#xD;
          -  Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or&#xD;
             treated with radiation or chemotherapy within the past 12 months;&#xD;
&#xD;
          -  Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or&#xD;
             greater renal disease, liver failure;&#xD;
&#xD;
          -  Diagnosis of a terminal illness and/or in hospice care;&#xD;
&#xD;
          -  Residence in long-term care facility;&#xD;
&#xD;
          -  Cognitive impairment based on the Callahan 6-item scale&#xD;
&#xD;
          -  Plan to move out of the area or transfer care outside PAMF during the study period;&#xD;
&#xD;
          -  Investigator discretion for reasons of clinical safety or protocol adherence.&#xD;
&#xD;
        ENGAGE&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        • RAINBOW participant&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Weight over 350 pounds&#xD;
&#xD;
          -  MRI is contraindicated&#xD;
&#xD;
          -  Traumatic brain injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Ma, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leanne Williams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>May 8, 2020</results_first_submitted>
  <results_first_submitted_qc>June 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 11, 2020</results_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Jun Ma, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>BMI</keyword>
  <keyword>Depressive symptoms</keyword>
  <keyword>Integrated therapy</keyword>
  <keyword>Cardiometabolic risk</keyword>
  <keyword>Self-regulation</keyword>
  <keyword>Behavior change</keyword>
  <keyword>Precision medicine</keyword>
  <keyword>Lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02246413/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>RAINBOW Intervention Program</title>
          <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual Care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>12-months (Primary Outcome)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="169"/>
                <participants group_id="P2" count="175"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24-months (Secondary Outcome)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="173"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RAINBOW Intervention Program</title>
          <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual Care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="204"/>
            <count group_id="B2" value="205"/>
            <count group_id="B3" value="409"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" spread="12.2"/>
                    <measurement group_id="B2" value="51.0" spread="11.9"/>
                    <measurement group_id="B3" value="51.0" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-Hispanic White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <population>287 women plus 122 men equal to the 409 total sample.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>All</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.7" spread="6.9"/>
                    <measurement group_id="B2" value="36.6" spread="5.8"/>
                    <measurement group_id="B3" value="36.7" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Women</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="144"/>
                    <count group_id="B2" value="143"/>
                    <count group_id="B3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.8" spread="6.6"/>
                    <measurement group_id="B2" value="37.3" spread="5.9"/>
                    <measurement group_id="B3" value="37.0" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Men</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                    <count group_id="B2" value="62"/>
                    <count group_id="B3" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.4" spread="7.5"/>
                    <measurement group_id="B2" value="35.1" spread="5.5"/>
                    <measurement group_id="B3" value="35.7" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Health Questionnaire 9-items (PHQ-9)</title>
          <description>The 9-item Patient Health Questionnaire (PHQ-9) total score is the sum of the scores of the 9 items, ranging from 0 to 27. Higher scores represent more severe depression symptoms. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.1" spread="3.2"/>
                    <measurement group_id="B2" value="13.5" spread="3.0"/>
                    <measurement group_id="B3" value="13.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression Symptom Checklist 20-items (SCL-20)</title>
          <description>Depression Symptom Checklist 20 (SCL-20), total average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). Higher scores represent more severe depression symptoms. SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.5" spread="0.5"/>
                    <measurement group_id="B2" value="1.5" spread="0.6"/>
                    <measurement group_id="B3" value="1.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Taking antidepressant medications</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="204"/>
                    <count group_id="B2" value="205"/>
                    <count group_id="B3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Co-Primary Outcome: Body Mass Index (BMI)</title>
        <description>Integrated intervention treatment response</description>
        <time_frame>12 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Co-Primary Outcome: Body Mass Index (BMI)</title>
          <description>Integrated intervention treatment response</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="7.1"/>
                    <measurement group_id="O2" value="36.6" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score</title>
        <description>Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score</title>
          <description>Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.7"/>
                    <measurement group_id="O2" value="1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Mass Index</title>
        <description>Derived from height and weight measurements</description>
        <time_frame>24 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Mass Index</title>
          <description>Derived from height and weight measurements</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" spread="7.3"/>
                    <measurement group_id="O2" value="36.2" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Symptom Checklist 20 (SCL-20) Score</title>
        <description>SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Symptom Checklist 20 (SCL-20) Score</title>
          <description>SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, &gt;0.75-1.5, &gt;1.5- 2.0, and &gt;2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.8"/>
                    <measurement group_id="O2" value="1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Weight measurements</description>
        <time_frame>12 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Weight measurements</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.8" spread="22.8"/>
                    <measurement group_id="O2" value="103.4" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Weight measurements</description>
        <time_frame>24 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Weight measurements</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.8" spread="24"/>
                    <measurement group_id="O2" value="102.4" spread="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Remission (Number of Participants With SCL-20 Scores &lt;0.5)</title>
        <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Remission (Number of Participants With SCL-20 Scores &lt;0.5)</title>
          <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Remission (Number of Participants With SCL-20 Score &lt;0.5)</title>
        <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Remission (Number of Participants With SCL-20 Score &lt;0.5)</title>
          <description>Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores &lt;0.5</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</title>
        <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</title>
          <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</title>
        <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)</title>
          <description>Depression treatment response defined by 50% decline in SCL-20 symptom scores</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</title>
        <description>5% or greater weight loss from baseline</description>
        <time_frame>12 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</title>
          <description>5% or greater weight loss from baseline</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="184"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</title>
        <description>5% or greater weight loss from baseline</description>
        <time_frame>24 months</time_frame>
        <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)</title>
          <description>5% or greater weight loss from baseline</description>
          <population>In the case of missing study-measured weight, the closest EHR weight within 3 months of the due date of a missed study visit or self-reported weight (if no EHR weight) was used. So the number of participants analyzed is not consistent with the number in the Participant Flow module.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost-effectiveness</title>
        <description>Average annual per person spending on medical care services (2018 real US dollars)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Cost-effectiveness</title>
          <description>Average annual per person spending on medical care services (2018 real US dollars)</description>
          <units>US dollars</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1994" lower_limit="1473" upper_limit="2515"/>
                    <measurement group_id="O2" value="1773" lower_limit="1209" upper_limit="2337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</title>
        <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</title>
          <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.3" spread="25.9"/>
                    <measurement group_id="O2" value="56.1" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety (GAD-7)</title>
        <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety (GAD-7)</title>
          <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="3.8"/>
                    <measurement group_id="O2" value="6.1" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</title>
        <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</title>
          <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1" spread="8.7"/>
                    <measurement group_id="O2" value="46.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</title>
        <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</title>
          <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" spread="9.6"/>
                    <measurement group_id="O2" value="43.3" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability (Sheehan Disability Scale)</title>
        <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Disability (Sheehan Disability Scale)</title>
          <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="6.7"/>
                    <measurement group_id="O2" value="8.4" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Activity)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Activity)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="0.7"/>
                    <measurement group_id="O2" value="1.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Pain)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Pain)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.8"/>
                    <measurement group_id="O2" value="2.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.9"/>
                    <measurement group_id="O2" value="2.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.7"/>
                    <measurement group_id="O2" value="1.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.3"/>
                    <measurement group_id="O2" value="1.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Disturbance T-score</title>
        <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Disturbance T-score</title>
          <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="9.3"/>
                    <measurement group_id="O2" value="55.1" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Impairment T-score</title>
        <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Impairment T-score</title>
          <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="9.6"/>
                    <measurement group_id="O2" value="55.5" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Regulation of Cognition</title>
        <description>Regulation of cognition is measured using lab-based fMRI. To measure regulation of cognition, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various cognitive control web-based tasks, and online questionnaires administered with REDCap (COPE Inventory for Cognitive Coping and Clutter Image Rating Scale). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
        <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
        <posting_date>08/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Regulation of Self-reflection</title>
        <description>Regulation of cognition is measured using lab-based fMRI. To measure regulation of self-reflection, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, and online questionnaires administered with REDCap (BRISC Questionnaire of Emotional Resilience and Self-efficacy). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
        <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
        <posting_date>08/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Regulation of Emotion</title>
        <description>Regulation of emotion is measured using lab-based fMRI. To measure regulation of emotion, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various emotional web-based tasks, and online questionnaires administered with REDCap (emotional regulation questionnaire, early life stress questionnaire, and emotional regulation ratings success and strategies). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.</description>
        <time_frame>Baseline, 2, 6, 12, and 24 months</time_frame>
        <posting_date>08/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</title>
        <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)</title>
          <description>Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" spread="30.6"/>
                    <measurement group_id="O2" value="50.6" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety (GAD-7)</title>
        <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety (GAD-7)</title>
          <description>Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="4.8"/>
                    <measurement group_id="O2" value="5.9" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</title>
        <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )</title>
          <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" spread="9.1"/>
                    <measurement group_id="O2" value="45.4" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</title>
        <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )</title>
          <description>Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" spread="9.9"/>
                    <measurement group_id="O2" value="43.9" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability (Sheehan Disability Scale)</title>
        <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Disability (Sheehan Disability Scale)</title>
          <description>Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="6"/>
                    <measurement group_id="O2" value="6.9" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Activity)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Activity)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.8"/>
                    <measurement group_id="O2" value="1.7" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Pain)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Pain)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0.8"/>
                    <measurement group_id="O2" value="2.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0.9"/>
                    <measurement group_id="O2" value="2.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Mobility)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.9"/>
                    <measurement group_id="O2" value="1.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</title>
        <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Utility-based Health-related Quality of Life (EQ-5D-Self-care)</title>
          <description>Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                    <measurement group_id="O2" value="1.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Disturbance T-score</title>
        <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Disturbance T-score</title>
          <description>Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9" spread="9.7"/>
                    <measurement group_id="O2" value="55" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Impairment T-score</title>
        <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Impairment T-score</title>
          <description>Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2" spread="9.7"/>
                    <measurement group_id="O2" value="54.2" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Leisure Time Physical Activity</title>
        <description>Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall.</description>
        <time_frame>7-day Physical Activity Recall was administered at 12 months</time_frame>
        <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Leisure Time Physical Activity</title>
          <description>Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall.</description>
          <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months.</population>
          <units>MET minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="704.5" spread="984.4"/>
                    <measurement group_id="O2" value="752.4" spread="1111.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Energy Expenditure</title>
        <description>Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs).</description>
        <time_frame>7-day Physical Activity Recall was administered at 12 months</time_frame>
        <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Energy Expenditure</title>
          <description>Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs).</description>
          <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 134 in RAINBOW intervention and 139 in Usual care also completed the 7-day Physical Activity Recall at 12 months.</population>
          <units>kilocalories/kilogram/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1" spread="2.2"/>
                    <measurement group_id="O2" value="33.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Calorie Intake</title>
        <description>Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.</description>
        <time_frame>One day's 24-hour dietary recall was administered at 12 months</time_frame>
        <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Calorie Intake</title>
          <description>Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.</description>
          <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months.</population>
          <units>kilocalories/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1592.4" spread="587.0"/>
                    <measurement group_id="O2" value="1591.3" spread="621.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DASH (Dietary Approach to Stop Hypertension) Score</title>
        <description>Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality</description>
        <time_frame>One day's 24-hour dietary recall was administered at 12 months</time_frame>
        <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>RAINBOW Intervention Program</title>
            <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care.</description>
          </group>
        </group_list>
        <measure>
          <title>DASH (Dietary Approach to Stop Hypertension) Score</title>
          <description>Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality</description>
          <population>At 12 months, 169 in RAINBOW intervention and 175 in Usual Care completed the SCL-20, therefore were counted in retention in the Participant Flow module. Among them, 131 in RAINBOW intervention and 135 in Usual care also completed the 24-hour diet recalls at 12 months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Primary and secondary outcome period (up to 24-months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>RAINBOW Intervention Program</title>
          <description>An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.&#xD;
RAINBOW Intervention Program: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual Care.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphoma diagnosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac problems</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes diagnosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Digestive system problem</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal problems</sub_title>
                <description>Adverse Events were monitored in these classifications and cannot be separated.</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="204"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system problem</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric problems</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Reproductive system problems</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin problem</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="204"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphatic problems</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac problems</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="204"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear problem</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine problems</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Digestive system problem</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other problems</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal problems</sub_title>
                <description>Adverse Events were monitored in these classifications and cannot be separated.</description>
                <counts group_id="E1" events="30" subjects_affected="22" subjects_at_risk="204"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign tumor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system problem</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="204"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric problem</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Reproductive system problems</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="204"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory problem</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="204"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin problems</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="204"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular problems</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="204"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nan Lv, PhD, Research Scientist</name_or_title>
      <organization>Univeristy of Illinois, Chicago</organization>
      <phone>312-802-1072</phone>
      <email>lvn2017@uic.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246413
org study id: 14-05-323
secondary id: R01HL119453
secondary id: UH2HL132368
nct id: NCT02246413
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical
      and cost effectiveness and implementation potential of a primary care integrated
      multicondition intervention program to help improve mood and weight for obese adults with
      clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation
      added to the main trial with funding through the NIH common fund for the Science of Behavior
      Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial
      participants will be consented to undergo additional assays evaluating neurobiological
      mechanisms of self-regulation.
The large numbers of primary care patients affected by coexisting obesity and depression and
      common risk factors for diabetes and heart disease underscore the urgency of developing
      effective, accessible, and sustainable interventions that use an integrated, multicondition
      care management approach. The RAINBOW trial will rigorously evaluate the clinical and cost
      effectiveness and potential for "real-world" implementation of an innovative intervention
      that integrates a behavioral weight loss program and a collaborative stepped care program for
      depression, incorporates conventional clinic- and home-based modes of care delivery (e.g.,
      office visits plus phone consults and take-home DVD), and leverages low-cost, wide-reach
      health information technologies (e.g., Web, secure email, and mobile texting). Beginning Jan
      11, 2016, at least 100 of newly enrolled trial participants will also be consented to undergo
      additional assays evaluating neurobiological mechanisms of self-regulation, including
      emotional regulation, cognitive control and self-reflection. Given its focus on transforming
      primary care management of obesity and depression and common cardiometabolic risk factors to
      evidence-based, patient-centered care, as well as the likely scalability of the proposed
      intervention, the study has high potential for significant clinical and public health impact.
      Furthermore, elucidating the neurobiological mechanisms of self-regulation will significantly
      advance precision lifestyle medicine by enabling mechanism-targeted individualization of
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Co-Primary Outcome: Body Mass Index (BMI)
time frame: 12 months
description: Integrated intervention treatment response
measure: Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
time frame: 12 months
description: Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.
measure: Body Mass Index
time frame: 24 months
description: Derived from height and weight measurements
measure: Depression Symptom Checklist 20 (SCL-20) Score
time frame: 24 months
description: SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.
measure: Weight
time frame: 12 months
description: Weight measurements
measure: Weight
time frame: 24 months
description: Weight measurements
measure: Depression Remission (Number of Participants With SCL-20 Scores <0.5)
time frame: 12 months
description: Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5
measure: Depression Remission (Number of Participants With SCL-20 Score <0.5)
time frame: 24 months
description: Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5
measure: Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
time frame: 12 months
description: Depression treatment response defined by 50% decline in SCL-20 symptom scores
measure: Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
time frame: 24 months
description: Depression treatment response defined by 50% decline in SCL-20 symptom scores
measure: Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
time frame: 12 months
description: 5% or greater weight loss from baseline
measure: Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
time frame: 24 months
description: 5% or greater weight loss from baseline
measure: Cost-effectiveness
time frame: 12 months
description: Average annual per person spending on medical care services (2018 real US dollars)
measure: Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
time frame: 12 months
description: Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.
measure: Anxiety (GAD-7)
time frame: 12 months
description: Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
measure: Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
time frame: 12 months
description: Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
measure: Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
time frame: 12 months
description: Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
measure: Disability (Sheehan Disability Scale)
time frame: 12 months
description: Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.
measure: Utility-based Health-related Quality of Life (EQ-5D-Activity)
time frame: 12 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Pain)
time frame: 12 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
time frame: 12 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Mobility)
time frame: 12 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Self-care)
time frame: 12 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Sleep Disturbance T-score
time frame: 12 months
description: Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
measure: Sleep Impairment T-score
time frame: 12 months
description: Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
measure: Regulation of Cognition
time frame: Baseline, 2, 6, 12, and 24 months
description: Regulation of cognition is measured using lab-based fMRI. To measure regulation of cognition, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various cognitive control web-based tasks, and online questionnaires administered with REDCap (COPE Inventory for Cognitive Coping and Clutter Image Rating Scale). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
measure: Regulation of Self-reflection
time frame: Baseline, 2, 6, 12, and 24 months
description: Regulation of cognition is measured using lab-based fMRI. To measure regulation of self-reflection, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, and online questionnaires administered with REDCap (BRISC Questionnaire of Emotional Resilience and Self-efficacy). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
measure: Regulation of Emotion
time frame: Baseline, 2, 6, 12, and 24 months
description: Regulation of emotion is measured using lab-based fMRI. To measure regulation of emotion, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various emotional web-based tasks, and online questionnaires administered with REDCap (emotional regulation questionnaire, early life stress questionnaire, and emotional regulation ratings success and strategies). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
measure: Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
time frame: 24 months
description: Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.
measure: Anxiety (GAD-7)
time frame: 24 months
description: Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
measure: Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
time frame: 24 months
description: Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
measure: Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
time frame: 24 months
description: Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
measure: Disability (Sheehan Disability Scale)
time frame: 24 months
description: Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with signiﬁcant functional impairment.
measure: Utility-based Health-related Quality of Life (EQ-5D-Activity)
time frame: 24 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Pain)
time frame: 24 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
time frame: 24 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Mobility)
time frame: 24 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Utility-based Health-related Quality of Life (EQ-5D-Self-care)
time frame: 24 months
description: Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
measure: Sleep Disturbance T-score
time frame: 24 months
description: Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
measure: Sleep Impairment T-score
time frame: 24 months
description: Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
measure: Leisure Time Physical Activity
time frame: 7-day Physical Activity Recall was administered at 12 months
description: Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall.
measure: Total Energy Expenditure
time frame: 7-day Physical Activity Recall was administered at 12 months
description: Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs).
measure: Total Calorie Intake
time frame: One day's 24-hour dietary recall was administered at 12 months
description: Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.
measure: DASH (Dietary Approach to Stop Hypertension) Score
time frame: One day's 24-hour dietary recall was administered at 12 months
description: Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality
arm group label: RAINBOW Intervention Program
arm group type: Experimental
description: An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care.
intervention type: Behavioral
intervention name: RAINBOW Intervention Program
description: Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
arm group label: RAINBOW Intervention Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Ma, MD, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Leanne Williams, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Jun Ma, MD, PhD
investigator title: Professor
mesh term: Obesity
mesh term: Depression
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 