- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591886
The Peer-Delivered "Mind. Body. Voice." Program for High School Women (mbv)
Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- To explore young women's experiences of participating in the program, including strengths and limitations and perspectives on specific activities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- University of Colorado Boulder
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- High school women, grades 9-12
Exclusion Criteria:
- Prior participation in the Body Project
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mind. body. voice.
The 10-week mind.
body.
voice.
program
|
The mbv program consists of 10 weekly sessions that include a variety of practices, including: cognitive dissonance exercises, contemplative practices, guided discussion and community building.
|
No Intervention: Control
Assessment-only control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dieting Behavior and Restraint
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of dieting behavior and restricted eating (scale 1-5 with higher scores indicating higher levels of dieting and restriction)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Body Dissatisfaction Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Objectified Body Consciousness Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of body monitoring and surveillance (scale 1-5 with higher scores indicating higher levels of body surveillance)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Ideal Body Stereotype Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of internalization of ideal body stereotypes (scale 1-5 with higher scores indicating higher levels of internalization)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Body Appreciation Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Social Contribution Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of sense of contributing to society (scale 1-5 with higher scores indicating higher levels of contribution)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Engaged Living Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of values-based living (scale 1-5 with higher scores indicating higher levels of living based on values)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Multidimensional Assessment of Interoceptive Awareness
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of somatic awareness (scale 1-5 with higher scores indicating higher levels of somatic awareness)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Self-Liking and Self-Competence Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of how much one likes oneself and considers oneself competent (scale 1-5 with higher scores indicating higher levels of self-liking and self-competence)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Proactive Coping Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Self-Efficacy Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of effectiveness in handling challenges and achieving goals (scale 1-5 with higher scores indicating higher levels of self-efficacy)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Internalization of Media Appearance Ideals
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of internalized appearance ideals in the media (scale 1-5 with higher scores indicating higher levels of internalization)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Sociocultural Pressures Around Appearance
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of sociocultural pressures related to appearance (scale 1-5 with higher scores indicating higher levels of pressure)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Peer Influence on Appearance Concerns
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of influence of peers on appearance concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Group Belonging Scale (intervention group only)
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of sense of anticipated (baseline) and experienced (follow-up) belonging with intervention program group (scale 1-7 with higher scores indicating higher levels of belonging)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Self-Compassion Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Belonging Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Eating Disorder Symptoms and Diagnoses
Time Frame: baseline, post-intervention (10 weeks after baseline),
|
Interview data on eating disorder symptoms and diagnoses (Kiddie Schedule for Affective Disorders and Schizophrenia, Eating Disorder Supplement)
|
baseline, post-intervention (10 weeks after baseline),
|
Change in Eating Attitudes Test 26
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of disordered eating behaviors (scale 1-6 with higher scores indicating higher levels of disordered eating)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Generalized Anxiety Disorder 7
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of anxiety (scale 1-4 with higher scores indicating higher levels of anxiety)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Patient Health Questionnaire 9
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of depression (scale 1-4 with higher scores indicating higher levels of depression)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in UCLA Loneliness Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Positive and Negative Affect Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of positive and negative affect (scale 1-6 with higher scores indicating higher affect levels)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in School Engagement and Belonging
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of engagement with schoolwork and belonging in school (scale 1-5 with higher scores indicating higher levels of engagement and belonging)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in School Grades and Attendance
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of grades and attendance
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Physical Health Questionnaire
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of health outcomes such as sleep and physical symptoms (scale 1-7 with higher scores indicating higher levels of health symptoms)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Change in Humanitarian Egalitarian Scale
Time Frame: baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Self-report measure of agreement with humanitarian and egalitarian values (scale 1-5 with higher scores indicating higher levels of agreement)
|
baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0007-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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