Clinical trial NCT04591886: The Peer-Delivered "Mind. Body. Voice." Program for High School Women
Official title: Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders in Adolescence
Keywords: Eating disorder prevention
Female
Adolescence
Peer delivery
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 120
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 a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, and an extended co-design process. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at five time points over the course of a year. Students will be recruited from two high schools and will be randomized to receive the mbv program or an assessment-only control group.

Detailed description: Eating disorders have the highest mortality rate of any psychiatric condition and are the second leading cause of mental health disability among young women. Given that eating disorders have their peak onset during adolescence (ages 16-19), prevention efforts among adolescent women are critical in order to avert the onset of these chronic and disabling disorders. The mbv program targets body image and appearance related pressures, awareness of body sensations, and agency and community building skills.The program consists of 10 weekly sessions and is delivered by peer facilitators. This study will implement and evaluate the mbv program at the high school level in order to examine the extent to which the program influences young women's mental health and well-being, particularly related to eating disorder risk factors and symptoms.

Utilizing a longitudinal randomized controlled trial, the study seeks to address the following aims:

1. To examine the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self- constructs, physical health and mood among participating high school women.
2. To explore young women's experiences of participating in the program, including strengths and limitations and perspectives on specific activities.

Eligibility criteria: Inclusion Criteria:

* High school women, grades 9-12

Exclusion Criteria:

* Prior participation in the Body Project

Primary outcomes:
measure: Change in Dieting Behavior and Restraint
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Body Dissatisfaction Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Objectified Body Consciousness Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Ideal Body Stereotype Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Body Appreciation Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Social Contribution Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Engaged Living Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Multidimensional Assessment of Interoceptive Awareness
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Self-Liking and Self-Competence Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Proactive Coping Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Self-Efficacy Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Internalization of Media Appearance Ideals
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Sociocultural Pressures Around Appearance
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Peer Influence on Appearance Concerns
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Group Belonging Scale (intervention group only)
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Self-Compassion Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Belonging Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
Secondary outcomes:
measure: Change in Eating Disorder Symptoms and Diagnoses
timeFrame: baseline, post-intervention (10 weeks after baseline),
measure: Change in Eating Attitudes Test 26
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Generalized Anxiety Disorder 7
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Patient Health Questionnaire 9
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in UCLA Loneliness Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Positive and Negative Affect Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in School Engagement and Belonging
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in School Grades and Attendance
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Physical Health Questionnaire
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
measure: Change in Humanitarian Egalitarian Scale
timeFrame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References: