<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/NCT04433247</url>
  </required_header>
  <id_info>
    <org_study_id>54596</org_study_id>
    <nct_id>NCT04433247</nct_id>
  </id_info>
  <brief_title>Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery</brief_title>
  <official_title>Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposed pilot study will evaluate whether this body acceptance class produces greater&#xD;
      reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body&#xD;
      dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms,&#xD;
      and future onset of eating disorders over 6-month follow-up in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body&#xD;
      Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year&#xD;
      follow-up, produced larger reductions in outcomes than credible alternative interventions,&#xD;
      been shown to engage the intervention target (valuation of the thin beauty ideal), and&#xD;
      produced effects in trials from several independent teams. Although undergraduate&#xD;
      peer-educator-led Body Project groups have produced larger reductions in outcomes than an&#xD;
      eating disorder education video, an unmoderated Internet-based prevention program, and even&#xD;
      clinician-led Body Project groups, it can be logistically difficult to schedule in-person&#xD;
      Body Project groups with high school and college students. One solution to this key&#xD;
      implementation barrier is to have peer educators deliver Body Project groups virtually over&#xD;
      the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered&#xD;
      peer-led Body Project groups produced greater reductions in eating disorder symptoms and&#xD;
      future onset of eating disorders than an active expressive-writing intervention. The proposed&#xD;
      pilot study will evaluate whether Body Project produces greater reductions in risk factor&#xD;
      symptoms, eating disorder symptoms, and future onset of eating disorders in this population.&#xD;
&#xD;
      Participation in the intervention will last four weeks. Participants will be randomly&#xD;
      assigned to the intervention condition or waitlist-control condition. Assessments will take&#xD;
      place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control&#xD;
      participants will receive the intervention after they complete their post-test assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes Assessor at post-test and 6 month follow-up are blind to participant randomization.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change over time in Body Dissatisfaction</measure>
    <time_frame>pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention</time_frame>
    <description>Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change over time in Thin Ideal Internalization</measure>
    <time_frame>pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention</time_frame>
    <description>The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change over time in Negative Affect</measure>
    <time_frame>pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention</time_frame>
    <description>Twenty items from the sadness, guilt, and fear/anxiety subscales from the Positive Affect and Negative Affect Scale-Revised will assess negative affect. Participants reported the extent to which they had felt negative emotions on scales ranging from 1 = very slightly or not at all to 5 = extremely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Dieting</measure>
    <time_frame>pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention</time_frame>
    <description>The 10-item Dutch Restrained Eating Scale will assess the frequency of dieting behaviors using a response scale ranging from 1 = never to 5 = always.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change over time in Eating Disorder symptoms</measure>
    <time_frame>pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention</time_frame>
    <description>Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Peer Led Group Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the virtual peer-led group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer Led Group Intervention</intervention_name>
    <description>Four week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions.</description>
    <arm_group_label>Peer Led Group Intervention</arm_group_label>
    <other_name>Body Project</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body image concerns&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>26 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>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</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 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Eric Stice</investigator_full_name>
    <investigator_title>Professor of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Peer Leader</keyword>
  <keyword>Feeding and Eating Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04433247
org study id: 54596
nct id: NCT04433247
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposed pilot study will evaluate whether this body acceptance class produces greater
      reductions in eating disorder risk factor symptoms (pursuit of the thin ideal, body
      dissatisfaction, dieting, dietary restraint and negative affect), eating disorder symptoms,
      and future onset of eating disorders over 6-month follow-up in this population.
Dozens of eating disorder prevention programs have been evaluated, but only the 4-hr Body
      Project has reduced eating disorder symptoms and future eating disorder onset over 3-4 year
      follow-up, produced larger reductions in outcomes than credible alternative interventions,
      been shown to engage the intervention target (valuation of the thin beauty ideal), and
      produced effects in trials from several independent teams. Although undergraduate
      peer-educator-led Body Project groups have produced larger reductions in outcomes than an
      eating disorder education video, an unmoderated Internet-based prevention program, and even
      clinician-led Body Project groups, it can be logistically difficult to schedule in-person
      Body Project groups with high school and college students. One solution to this key
      implementation barrier is to have peer educators deliver Body Project groups virtually over
      the Internet. A pilot trial in Sweden provided initial evidence that virtually-delivered
      peer-led Body Project groups produced greater reductions in eating disorder symptoms and
      future onset of eating disorders than an active expressive-writing intervention. The proposed
      pilot study will evaluate whether Body Project produces greater reductions in risk factor
      symptoms, eating disorder symptoms, and future onset of eating disorders in this population.

      Participation in the intervention will last four weeks. Participants will be randomly
      assigned to the intervention condition or waitlist-control condition. Assessments will take
      place at pre-intervention, post-intervention, and 6 month follow up. Waitlist control
      participants will receive the intervention after they complete their post-test assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Outcomes Assessor at post-test and 6 month follow-up are blind to participant randomization.
measure: Change over time in Body Dissatisfaction
time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
description: Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied
measure: Change over time in Thin Ideal Internalization
time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
description: The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
measure: Change over time in Negative Affect
time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
description: Twenty items from the sadness, guilt, and fear/anxiety subscales from the Positive Affect and Negative Affect Scale-Revised will assess negative affect. Participants reported the extent to which they had felt negative emotions on scales ranging from 1 = very slightly or not at all to 5 = extremely.
measure: Change over time in Dieting
time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
description: The 10-item Dutch Restrained Eating Scale will assess the frequency of dieting behaviors using a response scale ranging from 1 = never to 5 = always.
measure: Change over time in Eating Disorder symptoms
time frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
description: Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview
arm group label: Peer Led Group Intervention
arm group type: Experimental
description: In the virtual peer-led group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
arm group label: Wait-List Control
arm group type: No Intervention
description: Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention.
intervention type: Behavioral
intervention name: Peer Led Group Intervention
description: Four week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions.
arm group label: Peer Led Group Intervention
other name: Body Project
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Stice, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Eric Stice
investigator title: Professor of Psychiatry and Behavioral Sciences
mesh term: Feeding and Eating Disorders
sharing ipd: No