- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433247
Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery
Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body image concerns
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Peer Led Group Intervention
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.
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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.
Other Names:
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No Intervention: Wait-List Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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
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pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
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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
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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.
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pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
|
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Change over time in Dieting
Time Frame: pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
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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.
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pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
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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
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Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview
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pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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