The Peer-Delivered Body Project for Young Women in High School

Eating Disorders in Adolescence Clinical Trial

Official title:

Implementation and Evaluation of the Peer-Delivered Body Project for Young Women in High School

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263155
• Other study ID #: 18-0007-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: June 2020
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female high school student

Exclusion Criteria:

• Previous participation in the Body Project program

Related Conditions & MeSH terms

• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

Behavioral:
• The Body Project
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.

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	Change in UCLA Loneliness Scale	Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	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)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	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)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	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)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	Change in General Self-Efficacy Scale	Self-report measure of self-efficacy (scale 1-4 with higher scores indicating higher levels of self-efficacy)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	Change in Self-Compassion Scale	Self-report measure of self-compassion (scale 1-5 with higher scores indicating higher levels of self-compassion)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	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)	Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary	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)	Baseline
Secondary	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)	Post-intervention (4 weeks after baseline)
Secondary	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)	Post-intervention (4 weeks after baseline)
Secondary	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)	Post-intervention (4 weeks after baseline)
Secondary	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)	From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average