<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/NCT02198196</url>
  </required_header>
  <id_info>
    <org_study_id>1R21AT007845-01A1</org_study_id>
    <nct_id>NCT02198196</nct_id>
  </id_info>
  <brief_title>Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs</brief_title>
  <official_title>Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consumer Wellness Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Consumer Wellness Solutions</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the efficacy of a phone-based weight loss program&#xD;
      that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The&#xD;
      program is targeted at employees of certain companies who meet a cut-off score on a measure&#xD;
      of stress-related eating. The control group will receive a standard phone-based program with&#xD;
      no additional stress management information (Weight Talk-Standard).&#xD;
&#xD;
        -  Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience&#xD;
           decreases in their stress-related &amp; emotion-related eating compared to the Weight&#xD;
           Talk-Standard (WT-S; n=25) group.&#xD;
&#xD;
        -  Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.&#xD;
&#xD;
        -  Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased&#xD;
           eating self-efficacy, increased acceptance of weight-related thoughts &amp; feelings and&#xD;
           increased mindfulness compared to those in the WT-S control arm.&#xD;
&#xD;
        -  Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss&#xD;
           program as those in WT-S.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eating Inventory - Internal Disinhibition subscale</measure>
    <time_frame>Screening and 6-month follow-up</time_frame>
    <description>8 items, screens for emotion and stress-related eating habits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Screening and 6-month follow-up</time_frame>
    <description>Weight in pounds</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mindful Eating Questionnaire</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rapid Fruit and Vegetable Screener</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>10-item scale that assesses fruit and vegetable intake.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fat Screener</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>17-item scale that assesses fat intake</description>
  </other_outcome>
  <other_outcome>
    <measure>Sweets Eating</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>2-item scale that assesses high sugar food and drink intake</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress Scale - 4 item</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>a 4-item scale that evaluates the appraisal of stress in one's life</description>
  </other_outcome>
  <other_outcome>
    <measure>Binge Eating Scale</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>16-item scale that assesses the presence of binge eating behaviors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Behavioral Obesity Phenotype Scale</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>8-item scale that assesses lack of control, lack of satiation, and preoccupation with food. We include 6 out of the 8 original items; 2 of the items already exist in the Binge Eating Scale (BES). One additional Preoccupation with Food item was added.</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptance and Action Questionnaire for Weight Related Difficulties</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight.</description>
  </other_outcome>
  <other_outcome>
    <measure>Generalized Anxiety Disorder scale</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder.</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal Health Questionnaire</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>2-item scale that assesses the frequency of depressed mood over the past 2 weeks and is used as a preliminary screening tool for depression.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adapted Physical Activity Measure</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>11-item scale that assesses overall activity level over the past week, adapted from measure used in the National Health and Nutrition Examination Survey (NHANES)</description>
  </other_outcome>
  <other_outcome>
    <measure>Five Facet Mindfulness Questionnaire: Short Form</measure>
    <time_frame>Screening, 6-month follow-up</time_frame>
    <description>24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction and Adherence</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>11-item measure consisting of Likert scale and open-ended questions about the participants' experience with the intervention and their adherence to mindfulness practice assignments.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Weight Talk-Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WT-M retain the evidence-based elements of WT-S (control condition), including the DASH diet, physical activity components, and an emphasis on self-monitoring. However, each call in WT-M will include an emphasis on mindfulness and stress management that will not be included in the control condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Talk-Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Weight Talk-Standard is a phone and web-based weight loss intervention offered by employers as a benefit to their employees. Weight Talk is based on the NIH Clinical Guidelines on Identification, Evaluation and Treatment of Overweight and Obesity in Adults and utilizes the curriculum developed for the Diabetes Prevention Program. Weight Talk-S contains no additional stress management techniques.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Talk-Mindfulness</intervention_name>
    <arm_group_label>Weight Talk-Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be enrolled in the Weight Talk program, inclusion criteria:&#xD;
&#xD;
               -  Employment by one of the employers who contract for Weight Talk services&#xD;
&#xD;
               -  Being over 18 years of age&#xD;
&#xD;
               -  Speak and read English&#xD;
&#xD;
          -  Have a starting BMI between 25 and 35.&#xD;
&#xD;
          -  Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating&#xD;
             Inventory.&#xD;
&#xD;
          -  Have regular access to email and internet.&#xD;
&#xD;
          -  Willingness and ability to complete study and intervention procedures, including&#xD;
             completing assessments, engaging in moderate physical activity (e.g., walking,&#xD;
             swimming) and using the electronic scale at least once per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).&#xD;
&#xD;
          -  Past diagnosis of anorexia nervosa or bulimia nervosa.&#xD;
&#xD;
          -  Weight Talk program exclusion criteria include:&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Bariatric surgery within past 12 months or planned in the next 6 months&#xD;
&#xD;
               -  Undergoing dialysis&#xD;
&#xD;
               -  Have Type 1 Diabetes diagnosis&#xD;
&#xD;
          -  Women who are pregnant are not eligible for the program, but contraception is not&#xD;
             required as this is a low risk study&#xD;
&#xD;
          -  Currently using or planning to start using a pharmaceutical weight loss drug&#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>Lee Alekel, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National Center for Complementary and Integrative Health (NCCIH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kelly Carpenter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consumer Wellness Solutions</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Lovejoy, PhD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Alere Wellbeing, Inc</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 3, 2016</last_update_submitted>
  <last_update_submitted_qc>February 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT02198196
org study id: 1R21AT007845-01A1
nct id: NCT02198196
lead sponsor: 
has dmc: Yes
The purpose of this study is to explore the efficacy of a phone-based weight loss program
      that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The
      program is targeted at employees of certain companies who meet a cut-off score on a measure
      of stress-related eating. The control group will receive a standard phone-based program with
      no additional stress management information (Weight Talk-Standard).

        -  Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience
           decreases in their stress-related & emotion-related eating compared to the Weight
           Talk-Standard (WT-S; n=25) group.

        -  Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group.

        -  Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased
           eating self-efficacy, increased acceptance of weight-related thoughts & feelings and
           increased mindfulness compared to those in the WT-S control arm.

        -  Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss
           program as those in WT-S.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eating Inventory - Internal Disinhibition subscale
time frame: Screening and 6-month follow-up
description: 8 items, screens for emotion and stress-related eating habits
measure: Body weight
time frame: Screening and 6-month follow-up
description: Weight in pounds
measure: Mindful Eating Questionnaire
time frame: Screening, 6-month follow-up
description: 28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating.
measure: Rapid Fruit and Vegetable Screener
time frame: Screening, 6-month follow-up
description: 10-item scale that assesses fruit and vegetable intake.
measure: Fat Screener
time frame: Screening, 6-month follow-up
description: 17-item scale that assesses fat intake
measure: Sweets Eating
time frame: Screening, 6-month follow-up
description: 2-item scale that assesses high sugar food and drink intake
measure: Perceived Stress Scale - 4 item
time frame: Screening, 6-month follow-up
description: a 4-item scale that evaluates the appraisal of stress in one's life
measure: Binge Eating Scale
time frame: Screening, 6-month follow-up
description: 16-item scale that assesses the presence of binge eating behaviors.
measure: Behavioral Obesity Phenotype Scale
time frame: Screening, 6-month follow-up
description: 8-item scale that assesses lack of control, lack of satiation, and preoccupation with food. We include 6 out of the 8 original items; 2 of the items already exist in the Binge Eating Scale (BES). One additional Preoccupation with Food item was added.
measure: Acceptance and Action Questionnaire for Weight Related Difficulties
time frame: Screening, 6-month follow-up
description: 22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight.
measure: Generalized Anxiety Disorder scale
time frame: Screening, 6-month follow-up
description: 7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder.
measure: Personal Health Questionnaire
time frame: Screening, 6-month follow-up
description: 2-item scale that assesses the frequency of depressed mood over the past 2 weeks and is used as a preliminary screening tool for depression.
measure: Adapted Physical Activity Measure
time frame: Screening, 6-month follow-up
description: 11-item scale that assesses overall activity level over the past week, adapted from measure used in the National Health and Nutrition Examination Survey (NHANES)
measure: Five Facet Mindfulness Questionnaire: Short Form
time frame: Screening, 6-month follow-up
description: 24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations.
measure: Satisfaction and Adherence
time frame: 6-month follow-up
description: 11-item measure consisting of Likert scale and open-ended questions about the participants' experience with the intervention and their adherence to mindfulness practice assignments.
arm group label: Weight Talk-Mindfulness
arm group type: Experimental
description: WT-M retain the evidence-based elements of WT-S (control condition), including the DASH diet, physical activity components, and an emphasis on self-monitoring. However, each call in WT-M will include an emphasis on mindfulness and stress management that will not be included in the control condition.
arm group label: Weight Talk-Standard
arm group type: No Intervention
description: Weight Talk-Standard is a phone and web-based weight loss intervention offered by employers as a benefit to their employees. Weight Talk is based on the NIH Clinical Guidelines on Identification, Evaluation and Treatment of Overweight and Obesity in Adults and utilizes the curriculum developed for the Diabetes Prevention Program. Weight Talk-S contains no additional stress management techniques.
intervention type: Behavioral
intervention name: Weight Talk-Mindfulness
arm group label: Weight Talk-Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lee Alekel, PhD
role: Study Chair
affiliation: National Center for Complementary and Integrative Health (NCCIH)
last name: Kelly Carpenter, PhD
role: Principal Investigator
affiliation: Consumer Wellness Solutions
last name: Jennifer Lovejoy, PhD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss