- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794763
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
December 12, 2024 updated by: Eric Stice, Stanford University
This present study will compare the efficacy of in-person versus virtually-delivered Body Project groups.
It will also 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, negative affect, eating disorder symptoms, and the future onset of eating disorders over a 3-month follow-up in this population.
It will also evaluate the effectiveness of this body acceptance class's ability to impact social appearance anxiety, body compassion, and self-stigma surrounding attaining help.
Study Overview
Status
Completed
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.
The proposed study will evaluate the effectiveness of a peer-implemented, virtually delivered, body acceptance class compared to a peer-implemented, in-person delivery of the same class.
Participation in the intervention will last four weeks.
Participants will be randomly assigned to the in-person or virtual body acceptance class.
Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94306
- Stanford University
-
-
Maryland
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Saint Marys City, Maryland, United States, 20686
- St. Mary's College of Maryland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria: Participants had to express body image concerns and all gender identities besides cisgender and transgender men were eligible.
Exclusion Criteria:
- Cisgender and transgender men were excluded due to the fact that The Body Project is typically administered with groups of all cisgender women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Body Project: In Person Delivery
In the in-person 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.
|
A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities.
The program consists of four 60-minute sessions
Other Names:
|
|
Experimental: Body Project: Virtual Delivery
In the virtual peer-led group intervention held over Zoom, 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.
|
A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities.
The program consists of four 60-minute sessions
Other Names:
|
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, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
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.
The mean score across the items is reported.
Overall scores can range from 1 to 6 and a higher score indicate a greater level of body satisfaction.
|
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
|
Change Over Time in Thin Ideal Internalization
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
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.
The mean score across the items is reported.
Overall scores can range from 1 to 5 and a higher score indicates a greater level of thin ideal internalization.
|
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Project Specific Attitude Measures
Time Frame: Pre intervention obtained on intake, and immediately post intervention.
|
7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
|
Pre intervention obtained on intake, and immediately post intervention.
|
|
Body Project Specific Outcome Measures
Time Frame: Pre intervention obtained on intake, and immediately post intervention.
|
7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
|
Pre intervention obtained on intake, and immediately post intervention.
|
|
Change Over Time in Negative Affect
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
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.
The mean score across the items is reported.
Overall scores can range from 1 to 5 and a higher score indicates a greater level of negative affect.
|
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
|
Change Over Time in Dieting
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
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.
The mean score across the items is reported.
Overall scores can range from 1 to 5 and a higher score indicates greater frequency of dieting behaviors.
|
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
|
Body Comparison Orientation
Time Frame: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
The six selected items from the Body, Eating, and Exercise Comparison Orientation Scale will assess the frequency of body comparisons using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
The mean score across the items is reported.
Overall scores can range from 1 to 5 and a higher score indicates greater frequency of body comparison.
|
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
|
|
Change Over Time in Social Appearance Anxiety
Time Frame: Pre intervention obtained on intake, and immediately post intervention.
|
The 16-item Social Appearance Anxiety Scale will assess levels of social appearance anxiety using a response scale ranging from 1 = not at all to 5 = extremely.
|
Pre intervention obtained on intake, and immediately post intervention.
|
|
Change Over Time in Body Compassion
Time Frame: Pre intervention obtained on intake, and immediately post intervention.
|
The 10-item Body Appreciation Scale-2 will assess levels of body compassion using a response scale ranging from 1 = never to 5 = always.
|
Pre intervention obtained on intake, and immediately post intervention.
|
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Change Over Time in Self-Stigma of Seeking Help Scale
Time Frame: Pre intervention obtained on intake, and immediately post intervention.
|
The 10-item Self-Stigma of Seeking Help Scale will assess participants' views towards seeking help using a scale ranging from 1 = strongly disagree to 5 = strongly agree.
|
Pre intervention obtained on intake, and immediately post intervention.
|
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Number of Eating Disorder Behaviors (Events) as a Measure of Change Over Time in Eating Disorder Symptoms
Time Frame: Pre intervention and 3 months after the end 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 and 3 months after the end of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Stice, PhD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2022
Primary Completion (Actual)
March 5, 2024
Study Completion (Actual)
March 5, 2024
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 12, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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