<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/NCT01665989</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000824</org_study_id>
    <nct_id>NCT01665989</nct_id>
  </id_info>
  <brief_title>Improving Diabetes Outcomes Through Lifestyle Change (IDOLc)Study</brief_title>
  <acronym>IDOLc</acronym>
  <official_title>Improving Diabetes Outcomes Through Lifestyle Change (IDOLc) Translation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research project has two primary specific aims in the Partners HealthCare clinical&#xD;
      population and setting:&#xD;
&#xD;
        1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle&#xD;
           behavioral intervention program with usual care (UC) (brief nutrition counseling and&#xD;
           referral to Nutrition Services, the current standard), on the primary outcome of weight&#xD;
           loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and&#xD;
           prescription medication (doses and costs) for diabetes and its related conditions.&#xD;
&#xD;
           We hypothesize that participants who receive the translation of the Look AHEAD program&#xD;
           will lose significantly more weight and have lower glycemia, blood pressure,&#xD;
           cholesterol, and drug doses and costs for these conditions than participants who receive&#xD;
           UC.&#xD;
&#xD;
        2. To compare the effects of the two interventions on health behaviors, self-efficacy,&#xD;
           diabetes-specific quality-of-life and patient satisfaction with quality of care.&#xD;
&#xD;
      We hypothesize that participants who receive the translation of the Look AHEAD program will&#xD;
      be more satisfied with their care and will experience greater improvements in health&#xD;
      behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who&#xD;
      receive UC.&#xD;
&#xD;
      Secondary specific aim: To assess the cost-effectiveness of the two interventions and the&#xD;
      potential cost savings in terms of reductions in medication doses. In the current&#xD;
      environment, a cost effective approach to lifestyle change is imperative. The costs and&#xD;
      benefits of the interventions in this project will be carefully analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight (percent weight loss from baseline to 6 months)</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Weight will be measured in light street clothes (without shoes) to the nearest 0.1 kg using a digital research scale. Height will be measured using a stadiometer. BMI will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Total cholesterol, LDL cholesterol, HDL-cholesterol and triglyceride levels will be measured with standard methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Resting blood pressure will be measured in duplicate using an automated device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Prescriptions</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Prescription medications (doses and costs) for diabetes, blood pressure and lipids will be recorded at the initial visit before intervention and 6 months later at the final research visit once the intervention is completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Dietary behavior will be assessed using the Fat-Related Diet Questionnaire and the Restraint Subscale of the Dutch Eating Behavior Questionnaire; activity behavior will be assessed by the Global Physical Activity Questionnaire (GPAC), and self reported minutes of activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Changes in self-efficacy will be measured using the Diet Self-efficacy Scale, a 16-item scale that measures confidence in one's ability to adopt healthy dietary behaviors and the Exercise Self-Efficacy scale, a 5-item scale that measures confidence (7-point scale) in one's ability to persist with exercise in situations that involve potential barriers, e.g., negative affect and time constraints).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Specific Quality-of-Life</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Diabetes specific quality-of-life will be measured using the Problem Areas In Diabetes (PAID) scale, a 20-item self-report measure of diabetes-related emotional distress that has shown high internal reliability, sensitivity to change and clinical utility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Care</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Patient satisfaction and impact surveys have been adapted for pertinence from the Diabetes Quality of Life Measure (DQOL) will be administered. In addition, subjects will be asked questions at the end of the 6 month intervention period to rate their level of satisfaction with their interactions during the visits with the dietitian.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness and savings</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>We will prospectively track the different categories of possible costs (wages for interventionists, rent, intervention materials, phone bills, postage, photocopies and unforeseen expenses). We will track changes in medications made by the provider during and after completion of the intervention and calculate any associated changes in costs by intervention group. We will also record medication and nutrition and medical visit costs of usual care in the control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Group Lifestyle program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group lifestyle program used in the IDOLc study is adapted from the first 6 months of the Look AHEAD program and will include 19 group sessions offered over a six month period. Each of 2 groups will contain up to 15 patients with type 2 diabetes and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. The program fosters the development of knowledge and lifestyle skills to change diet and exercise habits through use of goal setting, problem solving, stimulus control and other behavioral techniques that have resulted in weight loss, weight maintenance and improved glycemic control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A research assistant will provide the usual care group participants with brief (~15-20 minutes) counseling which reviews an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes; and refer them to Nutrition Services for follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Lifestyle Program</intervention_name>
    <arm_group_label>Group Lifestyle program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Visits with a dietitian at nutrition services at MGH</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Overweight or obese (BMI &gt; 25)&#xD;
&#xD;
          -  HbA1c level 7.5-&lt; 11%&#xD;
&#xD;
          -  Systolic blood pressure (SBP) &lt; 160 mmHg, diastolic blood pressure (DBP) &lt; 100 mmHg&#xD;
&#xD;
          -  Triglyceride levels &lt; 600 mg/dL&#xD;
&#xD;
          -  Be on at least one non-metformin diabetes medication&#xD;
&#xD;
          -  If taking medication for a chronic disease such as hypothyroidism, must be on a stable&#xD;
             dose for the previous 6 months&#xD;
&#xD;
          -  Willing to lose 5-7% of body weight&#xD;
&#xD;
          -  Willing to increase activity to at least 175 minutes/week&#xD;
&#xD;
          -  Willing to commit to random assignment to either attend and participate in the 19-week&#xD;
             lifestyle change program or be referred to Nutrition Services for usual care&#xD;
&#xD;
          -  Stable health, with no severe medical comorbidities that might interfere with their&#xD;
             ability to participate in an intervention that includes increasing activity or&#xD;
             decreasing calories, such as severe psychiatric illness or significant heart disease&#xD;
&#xD;
          -  Have a primary care physician at Partners HealthCare&#xD;
&#xD;
          -  Be able to understand and communicate effectively in English&#xD;
&#xD;
          -  Have a blood glucose meter to self monitor blood glucose&#xD;
&#xD;
          -  Be willing to keep a food, exercise and blood glucose diary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not be on Byetta (exenatide), Victoza (liraglutide), Bydureon (exenatide extended&#xD;
             release), or Symlin (pramlintide)&#xD;
&#xD;
          -  Must not be pregnant or planning pregnancy in the next year&#xD;
&#xD;
          -  Must not be currently seeing a dietitian or participating in a weight loss program&#xD;
&#xD;
          -  Must not have had a weight change of more than 5 pounds in the previous 3 months&#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>Linda M Delahanty, M.S. R.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes Research Center - Massachusetts General Hospiral</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>September 23, 2015</last_update_submitted>
  <last_update_submitted_qc>September 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Linda M. Delahanty</investigator_full_name>
    <investigator_title>Clinical Research Program/Project Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01665989
org study id: 2012P000824
nct id: NCT01665989
lead sponsor: 
has dmc: Yes
This research project has two primary specific aims in the Partners HealthCare clinical
      population and setting:

        1. To compare the effects of two interventions, a translation of the Look AHEAD lifestyle
           behavioral intervention program with usual care (UC) (brief nutrition counseling and
           referral to Nutrition Services, the current standard), on the primary outcome of weight
           loss and secondary outcomes of HbA1c, blood pressure, fasting lipid levels, and
           prescription medication (doses and costs) for diabetes and its related conditions.

           We hypothesize that participants who receive the translation of the Look AHEAD program
           will lose significantly more weight and have lower glycemia, blood pressure,
           cholesterol, and drug doses and costs for these conditions than participants who receive
           UC.

        2. To compare the effects of the two interventions on health behaviors, self-efficacy,
           diabetes-specific quality-of-life and patient satisfaction with quality of care.

      We hypothesize that participants who receive the translation of the Look AHEAD program will
      be more satisfied with their care and will experience greater improvements in health
      behavior, self-efficacy, and diabetes-specific quality-of-life compared to participants who
      receive UC.

      Secondary specific aim: To assess the cost-effectiveness of the two interventions and the
      potential cost savings in terms of reductions in medication doses. In the current
      environment, a cost effective approach to lifestyle change is imperative. The costs and
      benefits of the interventions in this project will be carefully analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in weight (percent weight loss from baseline to 6 months)
time frame: baseline and 6 months
description: Weight will be measured in light street clothes (without shoes) to the nearest 0.1 kg using a digital research scale. Height will be measured using a stadiometer. BMI will be calculated.
measure: HbA1c
time frame: baseline and 6 months
measure: Lipids
time frame: baseline and 6 months
description: Total cholesterol, LDL cholesterol, HDL-cholesterol and triglyceride levels will be measured with standard methods.
measure: Blood Pressure
time frame: baseline and 6 months
description: Resting blood pressure will be measured in duplicate using an automated device.
measure: Medication Prescriptions
time frame: baseline and 6 months
description: Prescription medications (doses and costs) for diabetes, blood pressure and lipids will be recorded at the initial visit before intervention and 6 months later at the final research visit once the intervention is completed
measure: Health behaviors
time frame: baseline and 6 months
description: Dietary behavior will be assessed using the Fat-Related Diet Questionnaire and the Restraint Subscale of the Dutch Eating Behavior Questionnaire; activity behavior will be assessed by the Global Physical Activity Questionnaire (GPAC), and self reported minutes of activity.
measure: Self-efficacy
time frame: baseline and 6 months
description: Changes in self-efficacy will be measured using the Diet Self-efficacy Scale, a 16-item scale that measures confidence in one's ability to adopt healthy dietary behaviors and the Exercise Self-Efficacy scale, a 5-item scale that measures confidence (7-point scale) in one's ability to persist with exercise in situations that involve potential barriers, e.g., negative affect and time constraints).
measure: Diabetes Specific Quality-of-Life
time frame: baseline and 6 months
description: Diabetes specific quality-of-life will be measured using the Problem Areas In Diabetes (PAID) scale, a 20-item self-report measure of diabetes-related emotional distress that has shown high internal reliability, sensitivity to change and clinical utility.
measure: Satisfaction with Care
time frame: baseline and 6 months
description: Patient satisfaction and impact surveys have been adapted for pertinence from the Diabetes Quality of Life Measure (DQOL) will be administered. In addition, subjects will be asked questions at the end of the 6 month intervention period to rate their level of satisfaction with their interactions during the visits with the dietitian.
measure: Cost effectiveness and savings
time frame: baseline and 6 months
description: We will prospectively track the different categories of possible costs (wages for interventionists, rent, intervention materials, phone bills, postage, photocopies and unforeseen expenses). We will track changes in medications made by the provider during and after completion of the intervention and calculate any associated changes in costs by intervention group. We will also record medication and nutrition and medical visit costs of usual care in the control group.
arm group label: Group Lifestyle program
arm group type: Experimental
description: The group lifestyle program used in the IDOLc study is adapted from the first 6 months of the Look AHEAD program and will include 19 group sessions offered over a six month period. Each of 2 groups will contain up to 15 patients with type 2 diabetes and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. The program fosters the development of knowledge and lifestyle skills to change diet and exercise habits through use of goal setting, problem solving, stimulus control and other behavioral techniques that have resulted in weight loss, weight maintenance and improved glycemic control.
arm group label: Usual Care
arm group type: Active Comparator
description: A research assistant will provide the usual care group participants with brief (~15-20 minutes) counseling which reviews an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes; and refer them to Nutrition Services for follow up.
intervention type: Behavioral
intervention name: Group Lifestyle Program
arm group label: Group Lifestyle program
intervention type: Behavioral
intervention name: Usual Care
description: Visits with a dietitian at nutrition services at MGH
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda M Delahanty, M.S. R.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Linda M. Delahanty
investigator title: Clinical Research Program/Project Manager
mesh term: Diabetes Mellitus