The Peer-Delivered Body Project for Young Women in High School
Primary Purpose
Eating Disorders in Adolescence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Body Project
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders in Adolescence focused on measuring Eating disorder prevention, Body Project, Female, Adolescence, Peer delivery
Eligibility Criteria
Inclusion Criteria:
- Female high school student
Exclusion Criteria:
- Previous participation in the Body Project program
Sites / Locations
- University of Colorado Boulder
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: The Body Project for high school young women
Control
Arm Description
The 4-hour Body Project workshop delivered by trained peer leaders
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
Outcomes
Primary Outcome Measures
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)
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)
Change in Dutch Restrained Eating Scale
Self-report measure of dietary restraint (scale 1-5 with higher scores indicating higher levels of eating restraint)
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)
Secondary Outcome Measures
Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
Self-report measure of body monitoring and surveillance (scale 1-7 with higher scores indicating higher levels of body surveillance)
Change in UCLA Loneliness Scale
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Change in Inventory of Peer Influence on Eating Concerns
Self-report measure of peer influence on eating and body concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
Change in Patient Health Questionnaire (PHQ-9)
Self-report measure for depressive symptom severity(scale 0-3 with higher scores indicating higher levels of depression)
Change in Generalized Anxiety Disorder (GAD-7)
Self-report measure for symptoms of generalized anxiety (scale 0-3 with higher scores indicating higher levels of anxiety)
Change in General Self-Efficacy Scale
Self-report measure of self-efficacy (scale 1-4 with higher scores indicating higher levels of self-efficacy)
Change in Self-Compassion Scale
Self-report measure of self-compassion (scale 1-5 with higher scores indicating higher levels of self-compassion)
Change in Rosenberg Self-Esteem Scale
Self-report measure of global self-worth (scale 1-4 with higher scores indicating higher levels of self-esteem)
Sense of Belonging (Body Project group only)
Self-report measure of anticipated belonging with group (scale 1-7 with higher scores indicating higher levels of anticipated belonging)
Sense of Belonging Follow-Up (Body Project group only)
Self-report measure of belonging with group (scale 1-7 with higher scores indicating higher levels of experienced belonging)
Working Alliance Inventory (Body Project group only)
Self-report measure of therapeutic alliance with peer leaders (scale 1-5 with higher scores indicating higher levels of working alliance)
Program Satisfaction (Body Project group only)
Self-reported ratings of satisfaction with program and peer leaders (scale 1-4 with higher scores indicating higher levels of program satisfaction)
Fidelity and Competence (Body Project group only)
Observer-rated assessments of peer leader fidelity and competence (scale 1-10 with higher scores indicating higher levels of facilitator fidelity and competence)
Full Information
NCT ID
NCT04263155
First Posted
January 29, 2020
Last Updated
June 24, 2020
Sponsor
University of Colorado, Boulder
1. Study Identification
Unique Protocol Identification Number
NCT04263155
Brief Title
The Peer-Delivered Body Project for Young Women in High School
Official Title
Implementation and Evaluation of the Peer-Delivered Body Project for Young Women in High School
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Preventive models that can avert the onset of eating disorders and innovative delivery methods that increase engagement with care offer a promising approach to improving the mental health and wellness of young women. This study aims to implement and evaluate the Body Project, a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders with high school young women using a peer delivery model. This study will evaluate the impact of the Body Project 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 program or to the control group. The Body Project will be facilitated by college-aged young women who have been trained to deliver the Body Project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders in Adolescence
Keywords
Eating disorder prevention, Body Project, Female, Adolescence, Peer delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: The Body Project for high school young women
Arm Type
Experimental
Arm Description
The 4-hour Body Project workshop delivered by trained peer leaders
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
The Body Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Thin-Ideal Internalization Scale
Description
Self-report measure of endorsement of the thin ideal (scale 1-5 with higher scores indicating higher levels of thin ideal internalization)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Satisfaction and Dissatisfaction with Body Parts Scale
Description
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Dutch Restrained Eating Scale
Description
Self-report measure of dietary restraint (scale 1-5 with higher scores indicating higher levels of eating restraint)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Positive Affect and Negative Affect Scale-Revised
Description
Self-report measure of negative affect (scale 1-5 with higher scores indicating higher levels of negative affect)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary Outcome Measure Information:
Title
Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
Description
Self-report measure of body monitoring and surveillance (scale 1-7 with higher scores indicating higher levels of body surveillance)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in UCLA Loneliness Scale
Description
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Inventory of Peer Influence on Eating Concerns
Description
Self-report measure of peer influence on eating and body concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
Self-report measure for depressive symptom severity(scale 0-3 with higher scores indicating higher levels of depression)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Generalized Anxiety Disorder (GAD-7)
Description
Self-report measure for symptoms of generalized anxiety (scale 0-3 with higher scores indicating higher levels of anxiety)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in General Self-Efficacy Scale
Description
Self-report measure of self-efficacy (scale 1-4 with higher scores indicating higher levels of self-efficacy)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Self-Compassion Scale
Description
Self-report measure of self-compassion (scale 1-5 with higher scores indicating higher levels of self-compassion)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Change in Rosenberg Self-Esteem Scale
Description
Self-report measure of global self-worth (scale 1-4 with higher scores indicating higher levels of self-esteem)
Time Frame
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Title
Sense of Belonging (Body Project group only)
Description
Self-report measure of anticipated belonging with group (scale 1-7 with higher scores indicating higher levels of anticipated belonging)
Time Frame
Baseline
Title
Sense of Belonging Follow-Up (Body Project group only)
Description
Self-report measure of belonging with group (scale 1-7 with higher scores indicating higher levels of experienced belonging)
Time Frame
Post-intervention (4 weeks after baseline)
Title
Working Alliance Inventory (Body Project group only)
Description
Self-report measure of therapeutic alliance with peer leaders (scale 1-5 with higher scores indicating higher levels of working alliance)
Time Frame
Post-intervention (4 weeks after baseline)
Title
Program Satisfaction (Body Project group only)
Description
Self-reported ratings of satisfaction with program and peer leaders (scale 1-4 with higher scores indicating higher levels of program satisfaction)
Time Frame
Post-intervention (4 weeks after baseline)
Title
Fidelity and Competence (Body Project group only)
Description
Observer-rated assessments of peer leader fidelity and competence (scale 1-10 with higher scores indicating higher levels of facilitator fidelity and competence)
Time Frame
From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Female high school student
Exclusion Criteria:
- Previous participation in the Body Project program
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33370134
Citation
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.
Results Reference
derived
Learn more about this trial
The Peer-Delivered Body Project for Young Women in High School
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