<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/NCT01680224</url>
  </required_header>
  <id_info>
    <org_study_id>HD071900</org_study_id>
    <nct_id>NCT01680224</nct_id>
  </id_info>
  <brief_title>Effectiveness Trial of a Dissonance-Based Obesity Prevention Program</brief_title>
  <acronym>Project Health</acronym>
  <official_title>Effectiveness Trial of a Dissonance-Based Obesity Prevention Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is a major US public health problem. Few obesity prevention programs have reduced&#xD;
      risk for weight gain over follow-up and those that have are very intensive, making&#xD;
      dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy&#xD;
      Weight) targeting young adults with body dissatisfaction involving participant-driven healthy&#xD;
      dietary and physical activity lifestyle changes significantly reduced increases in body mass&#xD;
      index (BMI) and obesity onset relative to alternative interventions and assessment-only&#xD;
      controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy,&#xD;
      the investigators added dissonance-inducing activities regarding unhealthy dietary and&#xD;
      activity practices, drawing from a highly efficacious dissonance-based eating disorder&#xD;
      prevention program. A pilot trial found that this new Project Health intervention&#xD;
      significantly reduced increases in BMI relative to both the Healthy Weight intervention and&#xD;
      an educational brochure condition from pre to post. The investigators propose to conduct a&#xD;
      rigorous multisite effectiveness trial that will test whether adding the dissonance-induction&#xD;
      elements to the originally Healthy Weight intervention improves weight gain prevention&#xD;
      effects. 360 college students at risk for future weight by virtue of their age and weight&#xD;
      concerns will be randomized one of three conditions: (1) a refined 6-hr group-based&#xD;
      dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a&#xD;
      psychoeducational video (&quot;Weight of the World&quot;) condition. Participants will complete&#xD;
      assessments of % body fat, mediators (including objectively measured physical activity),&#xD;
      moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1 will test the hypothesis that Project Health significantly reduces increases in % body&#xD;
      fat relative to the Healthy Weight intervention and video control condition during a 2-yr&#xD;
      follow-up; secondary outcomes are BMI, depressive symptoms and eating disorder symptoms. The&#xD;
      investigators will also compare Healthy Weight to video controls.&#xD;
&#xD;
      Aim 2 will test the hypothesis that Project Health participants will experience increased&#xD;
      cognitive dissonance (an uncomfortable psychological state) regarding eating unhealthy foods&#xD;
      and engaging in sedentary behaviors, and that changes in dissonance mediate the program's&#xD;
      weight gain prevention effects. The investigators will also test whether reduced calorie&#xD;
      intake and increased physical activity mediate the effects of Project Health on change in %&#xD;
      body fat.&#xD;
&#xD;
      Aim 3 will test the hypothesis that intervention effects are amplified for participants with&#xD;
      elevated body dissatisfaction (which should increase motivation change) and preference for&#xD;
      consistency (which should maximize dissonance induction) and mitigated for participants who&#xD;
      report emotional eating and substance use (because these factors increase risk for&#xD;
      overeating).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Fat Percentage</measure>
    <time_frame>Changes in body fat from baseline to 2-year follow up</time_frame>
    <description>We will use air displacement plethysmography (ADP) via the Bod Pod S/T to assess % body fat. Two measures will be averaged. Body density, calculated as body mass divided by estimated body volume, is used to calculate age- and gender-adjusted body fat percentile scores, based on normative reference data (McCarthy et al., 2006). A pilot validity study (N = 30) revealed that direct DEXA measures of % body fat correlates much more strongly with ADP estimates of body fat (r = .88) than with BMI (r = .23). Change in age- and gender-adjusted body fat percentile over the 2-year follow-up will be the primary outcome. This assessment takes 3-5 minutes to complete.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Pathology</measure>
    <time_frame>Baseline and post intervention (6 weeks); 6/12/24 month follow-up</time_frame>
    <description>The Eating Disorder Diagnostic Interview, a brief semi-structured interview, will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder, which will allow us to exclude participants with these disorders. It also provides a continuous measure of overall eating disorder symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Affect</measure>
    <time_frame>Baseline and post intervention (6 weeks); 6/12/24 month follow-ups</time_frame>
    <description>The 20-item Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS: Watson et al., 1988) measures general negative affectivity and depressive symptoms. Using a Likert rating system, participants choose their degree of endorsement of negative affectivity items such as &quot;disgusted with self&quot; and &quot;lonely&quot; (response options: 1 = not at all; 5 = extremely).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Craving/Liking</measure>
    <time_frame>Baseline, 6 weeks (post intervention), 6/12/24 month follow ups</time_frame>
    <description>The 28-item Food Craving Inventory (FCI; White et al., 2002) assesses subjective cravings for individual foods (pasta, ice cream), asking: &quot;Over the past month, how often have you experienced a craving for the food?&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weighing Habits</measure>
    <time_frame>Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups</time_frame>
    <description>Participants will be asked how often they weighed themselves &quot;in the past two weeks&quot; at each assessment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline and post-intervention (6 weeks); 6/12/24 month follow-ups</time_frame>
    <description>Accelerometers will give objective measures of physical activity from each participant at each wave assessment.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Gain</condition>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Healthy Weight</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The main goal of the Healthy Weight intervention is to make small, sustainable changes to input and output on a weekly basis to achieve a balance between caloric intake and output. All sessions begin with a brief review of what was covered in the previous session, presentation of educational handouts, careful review of previous behavior change goals, and the development of healthy behavior change plans for the next session. Home exercises for all sessions consist of following individualized diet and exercise goals, and keeping a food and exercise log to determine areas for future healthy changes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Project Health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Project Health adds dissonance-inducing activities, discussions, and homework activities to the Healthy Weight basic intervention. Each session begins with a verbal commitment to participate (to underscore the voluntary nature of participation), includes discussions of completed home practice assignments and in-session writing/sharing exercises (to create accountability), and concludes with home exercises (to increase level of effort). Completed home assignments are videotaped in subsequent sessions to increase accountability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Some participants will be randomized to control condition whereby they will be given an psychoeducational video (&quot;Weight of the World&quot;)to view.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Weight</intervention_name>
    <arm_group_label>Healthy Weight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Project Health</intervention_name>
    <arm_group_label>Project Health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Control</intervention_name>
    <description>Participants will view a video on overweight and obesity</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  University student&#xD;
&#xD;
          -  Presents with self-reported &quot;weight concerns&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Eating Disorder&#xD;
&#xD;
          -  Obese&#xD;
&#xD;
          -  Underweight&#xD;
&#xD;
          -  Non-english speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Stice, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Rohde, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heather Shaw, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kyle Burger, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nathan Marti, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Oregon Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon State University</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oregon</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>94703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Research Institute</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas, Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 19, 2018</last_update_submitted>
  <last_update_submitted_qc>September 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Weight Gain</keyword>
  <keyword>Dissonance</keyword>
  <keyword>College,University Students</keyword>
  <keyword>Eating Disorders</keyword>
  <keyword>Obesity Prevention</keyword>
  <keyword>Selective Prevention</keyword>
  <keyword>Effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
    <mesh_term>Feeding and Eating Disorders</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/NCT01680224
org study id: HD071900
nct id: NCT01680224
lead sponsor: 
has dmc: Yes
Obesity is a major US public health problem. Few obesity prevention programs have reduced
      risk for weight gain over follow-up and those that have are very intensive, making
      dissemination difficult and costly. A brief 3-hr selective prevention program (Healthy
      Weight) targeting young adults with body dissatisfaction involving participant-driven healthy
      dietary and physical activity lifestyle changes significantly reduced increases in body mass
      index (BMI) and obesity onset relative to alternative interventions and assessment-only
      controls through 3-yr follow-up, though effects were small in magnitude. To enhance efficacy,
      the investigators added dissonance-inducing activities regarding unhealthy dietary and
      activity practices, drawing from a highly efficacious dissonance-based eating disorder
      prevention program. A pilot trial found that this new Project Health intervention
      significantly reduced increases in BMI relative to both the Healthy Weight intervention and
      an educational brochure condition from pre to post. The investigators propose to conduct a
      rigorous multisite effectiveness trial that will test whether adding the dissonance-induction
      elements to the originally Healthy Weight intervention improves weight gain prevention
      effects. 360 college students at risk for future weight by virtue of their age and weight
      concerns will be randomized one of three conditions: (1) a refined 6-hr group-based
      dissonance-based Project Health, (2) a 6-hr group-based Healthy Weight intervention, or (3) a
      psychoeducational video ("Weight of the World") condition. Participants will complete
      assessments of % body fat, mediators (including objectively measured physical activity),
      moderators, and other outcomes at pre, post, and 6, 12, and 24 month follow-ups.
Aim 1 will test the hypothesis that Project Health significantly reduces increases in % body
      fat relative to the Healthy Weight intervention and video control condition during a 2-yr
      follow-up; secondary outcomes are BMI, depressive symptoms and eating disorder symptoms. The
      investigators will also compare Healthy Weight to video controls.

      Aim 2 will test the hypothesis that Project Health participants will experience increased
      cognitive dissonance (an uncomfortable psychological state) regarding eating unhealthy foods
      and engaging in sedentary behaviors, and that changes in dissonance mediate the program's
      weight gain prevention effects. The investigators will also test whether reduced calorie
      intake and increased physical activity mediate the effects of Project Health on change in %
      body fat.

      Aim 3 will test the hypothesis that intervention effects are amplified for participants with
      elevated body dissatisfaction (which should increase motivation change) and preference for
      consistency (which should maximize dissonance induction) and mitigated for participants who
      report emotional eating and substance use (because these factors increase risk for
      overeating).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Body Fat Percentage
time frame: Changes in body fat from baseline to 2-year follow up
description: We will use air displacement plethysmography (ADP) via the Bod Pod S/T to assess % body fat. Two measures will be averaged. Body density, calculated as body mass divided by estimated body volume, is used to calculate age- and gender-adjusted body fat percentile scores, based on normative reference data (McCarthy et al., 2006). A pilot validity study (N = 30) revealed that direct DEXA measures of % body fat correlates much more strongly with ADP estimates of body fat (r = .88) than with BMI (r = .23). Change in age- and gender-adjusted body fat percentile over the 2-year follow-up will be the primary outcome. This assessment takes 3-5 minutes to complete.
measure: Eating Pathology
time frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-up
description: The Eating Disorder Diagnostic Interview, a brief semi-structured interview, will assess eating disorder symptoms. It provides diagnoses for anorexia nervosa, bulimia nervosa, and binge eating disorder, which will allow us to exclude participants with these disorders. It also provides a continuous measure of overall eating disorder symptoms.
measure: Negative Affect
time frame: Baseline and post intervention (6 weeks); 6/12/24 month follow-ups
description: The 20-item Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS: Watson et al., 1988) measures general negative affectivity and depressive symptoms. Using a Likert rating system, participants choose their degree of endorsement of negative affectivity items such as "disgusted with self" and "lonely" (response options: 1 = not at all; 5 = extremely).
measure: Food Craving/Liking
time frame: Baseline, 6 weeks (post intervention), 6/12/24 month follow ups
description: The 28-item Food Craving Inventory (FCI; White et al., 2002) assesses subjective cravings for individual foods (pasta, ice cream), asking: "Over the past month, how often have you experienced a craving for the food?"
measure: Weighing Habits
time frame: Baseline and post intervention (6 weeks); 6/12/24 mo follow-ups
description: Participants will be asked how often they weighed themselves "in the past two weeks" at each assessment.
measure: Physical Activity
time frame: Baseline and post-intervention (6 weeks); 6/12/24 month follow-ups
description: Accelerometers will give objective measures of physical activity from each participant at each wave assessment.
arm group label: Healthy Weight
arm group type: Active Comparator
description: The main goal of the Healthy Weight intervention is to make small, sustainable changes to input and output on a weekly basis to achieve a balance between caloric intake and output. All sessions begin with a brief review of what was covered in the previous session, presentation of educational handouts, careful review of previous behavior change goals, and the development of healthy behavior change plans for the next session. Home exercises for all sessions consist of following individualized diet and exercise goals, and keeping a food and exercise log to determine areas for future healthy changes.
arm group label: Project Health
arm group type: Experimental
description: Project Health adds dissonance-inducing activities, discussions, and homework activities to the Healthy Weight basic intervention. Each session begins with a verbal commitment to participate (to underscore the voluntary nature of participation), includes discussions of completed home practice assignments and in-session writing/sharing exercises (to create accountability), and concludes with home exercises (to increase level of effort). Completed home assignments are videotaped in subsequent sessions to increase accountability.
arm group label: Control
arm group type: Placebo Comparator
description: Some participants will be randomized to control condition whereby they will be given an psychoeducational video ("Weight of the World")to view.
intervention type: Behavioral
intervention name: Healthy Weight
arm group label: Healthy Weight
intervention type: Behavioral
intervention name: Project Health
arm group label: Project Health
intervention type: Behavioral
intervention name: Placebo Control
description: Participants will view a video on overweight and obesity
arm group label: Control
criteria: 
gender: All
minimum age: 17 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Stice, PhD
role: Principal Investigator
affiliation: Oregon Research Institute
last name: Paul Rohde, PhD
role: Study Director
affiliation: Oregon Research Institute
last name: Heather Shaw, PhD
role: Study Director
affiliation: Oregon Research Institute
last name: Kyle Burger, PhD
role: Study Director
affiliation: Oregon Research Institute
last name: Nathan Marti, PhD
role: Study Director
affiliation: Oregon Research Institute
facility: 
facility: 
facility: 
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Obesity
mesh term: Weight Gain
mesh term: Feeding and Eating Disorders