Clinical trial NCT04263155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders in Adolescence
Keywords: Eating disorder prevention
Body Project
Female
Adolescence
Peer delivery
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

- Female high school student

Exclusion Criteria:

- Previous participation in the Body Project program

Primary outcomes:
measure: Change in Thin-Ideal Internalization Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Satisfaction and Dissatisfaction with Body Parts Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Dutch Restrained Eating Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Positive Affect and Negative Affect Scale-Revised
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary outcomes:
measure: Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in UCLA Loneliness Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Inventory of Peer Influence on Eating Concerns
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in General Self-Efficacy Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Self-Compassion Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Change in Rosenberg Self-Esteem Scale
timeFrame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
measure: Sense of Belonging (Body Project group only)
timeFrame: Baseline
measure: Sense of Belonging Follow-Up (Body Project group only)
timeFrame: Post-intervention (4 weeks after baseline)
measure: Working Alliance Inventory (Body Project group only)
timeFrame: Post-intervention (4 weeks after baseline)
measure: Program Satisfaction (Body Project group only)
timeFrame: Post-intervention (4 weeks after baseline)
measure: Fidelity and Competence (Body Project group only)
timeFrame: From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
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.