NCT04433247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

June 10, 2020

Last Update Submit

September 27, 2021

Conditions

Eating Disorders

Keywords

PreventionPeer LeaderFeeding and Eating Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change over time in Negative Affect

    pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention

  • Change over time in Dieting

    pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention

  • Change over time in Eating Disorder symptoms

    pre intervention obtained on intake, immediately post intervention, and 6-months after the conclusion of the intervention

Study Arms (2)

Peer Led Group Intervention

EXPERIMENTAL

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.

Behavioral: Peer Led Group Intervention

Wait-List Control

NO 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.

Interventions

Peer Led Group InterventionBEHAVIORAL

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.

Also known as: Body Project
Peer Led Group Intervention

Eligibility Criteria

Age16 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Body image concerns

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Stice E, Bohon C, Shaw H, Desjardins CD. Efficacy of virtual delivery of a dissonance-based eating disorder prevention program and evaluation of a donation model to support sustained implementation. J Consult Clin Psychol. 2023 Mar;91(3):139-149. doi: 10.1037/ccp0000796. Epub 2023 Feb 6.

    PMID: 36745074DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Eric Stice, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor at post-test and 6 month follow-up are blind to participant randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

March 3, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)