Virtual Body Project Groups Led by Peers Versus Clinicians

Study Overview
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Brief Summary
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Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).

Official Title
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Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial

Conditions
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Eating Disorders, Body Image

Intervention / Treatment
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* Behavioral: Body Project
* Behavioral: Psychoeducational control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16-25 Female identifying Self-reported body image concerns Exclusion Criteria: Ongoing eating disorder diagnosis requiring treatment or hospitalization

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinician-led Body Project<br>Participants randomized to this condition will take part in virtual Body Project groups led by clinicians. | Behavioral: Body Project<br>* The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.<br>|
| Experimental: Peer-led Body Project<br>Participants randomized to this condition will take part in virtual Body Project groups led by peers. | Behavioral: Body Project<br>* The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.<br>|
| Active Comparator: Educational control<br>Participants randomized to the educational control group will receive educational videos on body image and eating disorders | Behavioral: Psychoeducational control<br>* Participants randomized to the educational control condition will receive videos addressing body image and eating disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in eating disorder symptoms | Assessed with the 28-item self-report Eating Disorder Examination Questionnaire (EDE-Q). Responses range from 0-6, whith higher scores indicating more severe eating disorder psychopathology | Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years | 
| Rate of eating disorder onset | Assessed with the eating disorder diagnostic interview Eating Disorder Assessment-5 (EDA-5). This is a semi-structured clinician-led diagnostic interview, based on the diagnostic criteria in the diagnostic manual DSM-5, and is efficient to determine eating disorder diagnostic status. This outcome will be used to determine proportion of participants with an eating disorder diagnosis. | Baseline/pretest, 1-year, and at 2-years | 
| Change over time in Body dissatisfaction | Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction | Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years | 
| Change over time in thin-ideal internalization | Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal. | Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years | 
| Negative affect | 20 negative items from the Positive and Negative Affect Schedule - Revised (PANAS-X) (Watson & Clark, 1992) to measure negative affect. Higher scores indicate higher levels of negative affect. Responses range from 1-5 | Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time in appearance ideals and perceived pressures | Assessed with the Attitudes Towards Appearance Questionnaire (SATAQ-4R) (Schaefer et al., 2017). A total of 31 items are included, and responses range from 1-5. Higher scores indicate higher levels of internalization/pressures | Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Body acceptance