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Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Led Group Intervention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring Prevention, Peer Leader, Feeding and Eating Disorders

Eligibility Criteria

16 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Body image concerns

Exclusion Criteria:

  • N/A

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Led Group Intervention

Wait-List Control

Arm Description

In the virtual 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.

Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
Change over time in Eating Disorder symptoms
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview

Full Information

First Posted
June 10, 2020
Last Updated
September 27, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04433247
Brief Title
Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery
Official Title
Pilot Testing Virtual Delivery of the Body Project Eating Disorder Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Prevention, Peer Leader, Feeding and Eating Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor at post-test and 6 month follow-up are blind to participant randomization.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Led Group Intervention
Arm Type
Experimental
Arm Description
In the virtual 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.
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Participants will be placed on a wait list for four weeks, an equal span of time of participants in the peer led group intervention. At four weeks, participants will complete their post-test assessment, then receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Peer Led Group Intervention
Other Intervention Name(s)
Body Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change over time in Body Dissatisfaction
Description
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
Time Frame
pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Title
Change over time in Thin Ideal Internalization
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Secondary Outcome Measure Information:
Title
Change over time in Negative Affect
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Title
Change over time in Dieting
Description
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.
Time Frame
pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention
Title
Change over time in Eating Disorder symptoms
Description
Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview
Time Frame
pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body image concerns Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer-Led Dissonance Eating Disorder Prevention: Virtual Delivery

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