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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an eating disorder prevention program called the Body Project to determine its effectiveness for young people in Nova Scotia. The researchers aim to assess the program's appeal, interest level, ease of facilitation, and effectiveness in reducing eating disorder risks. Participants will join group sessions led by peer mentors, complete questionnaires, and discuss their experiences in a focus group. The trial seeks girls or women aged 15-22 who live in Nova Scotia and are students or have internet access for virtual sessions. As an unphased trial, this study provides a unique opportunity to contribute to the development of a potentially impactful program for preventing eating disorders.

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 prior data suggests that the Body Project is safe for youth?

Research has shown that the Body Project is a safe and easy-to-follow program. Studies have found it can significantly reduce the risk of developing eating disorders without harming participants. For instance, one study found that participants in the Body Project were less likely to develop an eating disorder over three years compared to those who did not join. The program includes group sessions in a supportive environment, designed to help without causing stress or discomfort. Overall, participants find the Body Project manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Body Project because it offers a fresh approach to preventing eating disorders, particularly in individuals with appetite disorders. Unlike traditional treatments that often focus on nutritional counseling or medication, the Body Project is a cognitive-behavioral intervention that empowers participants to challenge societal beauty ideals and develop a healthier body image. This method targets the root psychological factors contributing to disordered eating, potentially leading to more sustainable long-term benefits. By addressing these underlying issues, the Body Project could provide a more holistic and preventative strategy compared to existing treatments.

What evidence suggests that the Body Project is effective for preventing eating disorders?

Research has shown that the Body Project, which participants in this trial will receive, helps lower the risk of eating disorders in young people. In past studies, it greatly improved issues like negative body image and unhealthy eating habits. Participants experienced these improvements not just immediately after the program, but also one to three years later. The program has also been successfully offered online, providing similar benefits for young women at risk. Overall, the Body Project has a strong history of reducing the risk of eating disorders. ^{1 4 6 7 8}

Who Is on the Research Team?

Susan Gamberg, PhD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422777/

Effectiveness of the Body Project Eating Disorder ... Unfortunately, treatments for the spectrum of eating disorders only produce lasting remission from eating disordered behaviors for 23% to 55% of patients ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06893627

Body Project SMIL: Prevention of Eating Disorders Among ... The present study aims to test the efficacy of the Body Project as a virtually delivered peer-led intervention including women with psychiatric illness and body ...

3. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00932-7

Effectiveness of virtually delivered Body Project groups to ... Effectiveness of virtually delivered Body Project groups to prevent eating disorders in young women at risk: a protocol for a randomized ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016882272300760X

Evaluation of a novel eating disorder prevention program ... Virtually delivered Diabetes Body Project decreased ED risk factors and symptoms in young women with type 1 diabetes.

5. blueprintsprograms.org blueprintsprograms.org/programs/836999999/body-project/

Body Project (2015) found that the following outcomes were significantly improved from baseline to 1-year follow-up and 2- and 3-year follow-ups: Negative affect; Eating ...

6. diabetesjournals.org diabetesjournals.org/care/article/48/2/220/157535/Diabetes-Body-Project-Acute-Effects-of-an-Eating

Diabetes Body Project: Acute Effects of an Eating Disorder ... The Diabetes Body Project produced significantly larger acute effects with small to medium effect sizes compared with educational controls and has potential ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4053817/

Dissonance-Based Prevention of Eating Disorder Risk ... Critically, the Body Project significantly reduced onset of sub/full threshold eating disorders through 3-year follow-up relative to assessment-only ...

8. nationaleatingdisorders.org nationaleatingdisorders.org/the-body-project/

The Body Project NEDA - National Eating Disorders ... The Body Project is a group-based intervention that provides a forum for high school girls & college aged women to develop healthy body image, self-esteem.