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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04591886
Other study ID # 18-0007-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 31, 2021

Study information

Verified date November 2021
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - High school women, grades 9-12 Exclusion Criteria: - Prior participation in the Body Project

Study Design


Intervention

Behavioral:
mind. body. voice.
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.

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 Dieting Behavior and Restraint 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
Primary Change in Body Dissatisfaction Scale 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
Primary Change in Objectified Body Consciousness Scale 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
Primary Change in Ideal Body Stereotype Scale 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
Primary Change in Body Appreciation Scale 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
Primary Change in Social Contribution Scale 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
Primary Change in Engaged Living Scale 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
Primary Change in Multidimensional Assessment of Interoceptive Awareness 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
Primary Change in Self-Liking and Self-Competence Scale 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
Primary Change in Proactive Coping Scale 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
Primary Change in Self-Efficacy Scale 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
Primary Change in Internalization of Media Appearance Ideals 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
Primary Change in Sociocultural Pressures Around Appearance 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
Primary Change in Peer Influence on Appearance Concerns 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
Primary Change in Group Belonging Scale (intervention group only) 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
Primary Change in Self-Compassion Scale 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
Primary Change in Belonging Scale 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 Change in Eating Disorder Symptoms and Diagnoses 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),
Secondary Change in Eating Attitudes Test 26 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
Secondary Change in Generalized Anxiety Disorder 7 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
Secondary Change in Patient Health Questionnaire 9 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
Secondary Change in UCLA Loneliness Scale 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
Secondary Change in Positive and Negative Affect Scale 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
Secondary Change in School Engagement and Belonging 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
Secondary Change in School Grades and Attendance 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
Secondary Change in Physical Health Questionnaire 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
Secondary Change in Humanitarian Egalitarian Scale 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
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