NCT04263155

Brief Summary

This study will evaluate the impact of the Body Project (a dissonance-based program designed to address body image concerns and prevent eating disorders) on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up). Young women will be recruited from two high schools and will be randomized to receive the Body Project or to the control group. The Body Project will be facilitated by college-aged women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

January 29, 2020

Last Update Submit

June 24, 2020

Conditions

Keywords

Eating disorder preventionBody ProjectFemaleAdolescencePeer delivery

Outcome Measures

Primary Outcomes (4)

  • Change in Thin-Ideal Internalization Scale

    Self-report measure of endorsement of the thin ideal (scale 1-5 with higher scores indicating higher levels of thin ideal internalization)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Satisfaction and Dissatisfaction with Body Parts Scale

    Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Dutch Restrained Eating Scale

    Self-report measure of dietary restraint (scale 1-5 with higher scores indicating higher levels of eating restraint)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Positive Affect and Negative Affect Scale-Revised

    Self-report measure of negative affect (scale 1-5 with higher scores indicating higher levels of negative affect)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

Secondary Outcomes (13)

  • Change in Objectified Body Consciousness Scale - Body Surveillance Subscale

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in UCLA Loneliness Scale

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Inventory of Peer Influence on Eating Concerns

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Patient Health Questionnaire (PHQ-9)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • Change in Generalized Anxiety Disorder (GAD-7)

    Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up

  • +8 more secondary outcomes

Study Arms (2)

Experimental: The Body Project for high school young women

EXPERIMENTAL

The 4-hour Body Project workshop delivered by trained peer leaders

Behavioral: The Body Project

Control

NO INTERVENTION

The business-as-usual comparison group does not participate in the Body Project but may engage in any other programs or services they normally would

Interventions

The Body Project is a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders. The curriculum consists of written, verbal, and behavioral exercises that provide participants with the opportunity to voluntarily and publicly critique the appearance ideal.

Experimental: The Body Project for high school young women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Female high school student

You may not qualify if:

  • \- Previous participation in the Body Project program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (1)

  • Vanderkruik R, Gist D, Dimidjian S. Preventing eating disorders in young women: An RCT and mixed-methods evaluation of the peer-delivered Body Project. J Consult Clin Psychol. 2020 Dec;88(12):1105-1118. doi: 10.1037/ccp0000609.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 10, 2020

Study Start

August 1, 2018

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

June 26, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations