Eating Disorder Prevention for Appetite Disorders

(EDPP-P2 Trial)

Overseen By Susan Gamberg, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Susan Gamberg

Disqualifiers: Previous participation in Body Project

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2-4 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Body Project for eating disorder prevention?

The Body Project has been shown to effectively reduce eating disorder symptoms and risk factors in various groups, including young women with body image concerns and Brazilian young women. It is particularly effective for those with higher initial symptoms and has demonstrated lasting effects up to six months after the intervention. ^{1 2 3 4 5}

Is the Body Project safe for humans?

The Body Project, a program aimed at preventing eating disorders, has been tested in various settings and populations, including young women and adolescents, without reports of safety concerns. It is generally considered safe for participants. ^{2 4 6 7 8}

How is the Body Project treatment different from other treatments for eating disorders?

The Body Project is unique because it is a group-based prevention program that uses dissonance-induction (creating a conflict between beliefs and behaviors) to reduce risk factors and symptoms of eating disorders. Unlike many other treatments, it has been shown to be effective in preventing the future onset of eating disorders, especially in young women. ^{2 4 9 10 11}

What is the purpose of this trial?

The goal of this study is to evaluate the Body Project, which is an eating disorder prevention program for youth 15-22 years old. The main question it aims to answer is 'Can an eating disorder prevention program, specifically the Body Project, be successfully delivered to youth in Nova Scotia'? This study will determine the feasibility of implementing the Body Project in Nova Scotia by assessing the following objectives: 1. Acceptability (how well the Body Project is received by, and the extent to which it is perceived as meeting the needs of, youth in Nova Scotia). 2. Demand (the extent to which youth in Nova Scotia are interested in and willing to engage with the program). 3. Integration (the extent to which the Body Project is judged as feasible by the group facilitators). 4. Effectiveness (the extent to which the Body Project reduces eating disorder risk factors in youth in Nova Scotia). Participants will: * Attend a total of 4 hours of Body Project group sessions, which are led by peer mentors. * Complete outcome measure questionnaires before their first session and after their last session. * Participate in a focus group with their session group members after their last session.

Research Team

Susan Gamberg, PhD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

This trial is for youth aged 15-22 in Nova Scotia who self-identify as girls/women, are students (for in-person groups), have internet and webcam access (for virtual groups), can complete English questionnaires, and consent to participate. Those who've done the Body Project before can't join.

Inclusion Criteria

I identify as a girl/woman.

For inclusion in an in-person group, must be currently enrolled as a student at the school where they will participate in sessions

For inclusion in a virtual BP group, must live in and/or attend school in Nova Scotia, have access to a computer with internet connection and a webcam that can be used in a private location, able to complete English computer-based self-report questionnaires, provides informed consent (or verbal assent with informed consent provided by parent/guardian)

Exclusion Criteria

Previous participation in the Body Project

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend a total of 4 hours of Body Project group sessions led by peer mentors

2-4 weeks

4 sessions (in-person)

Follow-up

Participants complete outcome measure questionnaires and participate in a focus group after their last session

Immediately following the last session

1 focus group (in-person)

Long-term Follow-up

Facilitators complete surveys to assess integration and effectiveness of the Body Project

24 months

Treatment Details

Interventions

• Body Project

Trial Overview The study tests the Body Project, an eating disorder prevention program. It checks if it's acceptable, demanded, integrable by facilitators, and effective at reducing risk factors among Nova Scotian youth through group sessions led by peers.

Participant Groups

Group I: the Body Project Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Susan Gamberg

Lead Sponsor

Queen Elizabeth II Health Sciences Centre Foundation

Collaborator

Trials

1

Recruited

20+

References

1. England pubmed.ncbi.nlm.nih.gov

Do participant, facilitator, or group factors moderate effectiveness of the Body Project? Implications for dissemination. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

A controlled trial of a dissonance-based eating disorders prevention program with Brazilian girls. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Dissonance-based eating disorder prevention among Brazilian young women: A randomized efficacy trial of the Body Project. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

From efficacy to effectiveness to broad implementation: Evolution of the Body Project. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Is a dissonance-based group intervention targeting thin-ideal internalization a successful potential add-on for specialized eating disorder care? A randomized feasibility and acceptability pilot study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing eating disorders in young women: An RCT and mixed-methods evaluation of the peer-delivered Body Project. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an eating disorder preventative intervention in primary care medical settings. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating whether a peer-led dissonance-based eating disorder prevention program prevents onset of each eating disorder type. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Interventions for preventing eating disorders in children and adolescents. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Preventing eating disorders. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Prevention of eating disorders: A systematic review and meta-analysis. [2022]