Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery

Eating Disorders Clinical Trial

Official title:

Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433247
• Other study ID #: 54596
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposed pilot study will 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 and negative affect), eating disorder symptoms, and future onset of eating disorders over 6-month follow-up in this population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

Inclusion Criteria:

• Body image concerns

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Peer Led Group Intervention
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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over time in Body Dissatisfaction	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	pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Primary	Change over time in Thin Ideal Internalization	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.	pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Secondary	Change over time in Negative Affect	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.	pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Secondary	Change over time in Dieting	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.	pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Secondary	Change over time in Eating Disorder symptoms	Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview	pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention