The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote

Eating Disorders in Adolescence Clinical Trial

Official title:

Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women - Remote

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591912
• Other study ID #: 18-0007-03
• Status: Completed
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• 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 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, an extended co-design process, and previous iterations of the mbv program. 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 three time points over the course of the 10-week program, which will be offered remotely in response to the COVID-19 pandemic. Students will be recruited from 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 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: 170
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• 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 or mind. body. voice. RCT

Related Conditions & MeSH terms

• Eating Disorders in Adolescence
• Feeding and Eating Disorders

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 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)
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)
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)
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)
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)
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)
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)
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)
Primary	Change in Group Belonging Scale	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)
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)
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)
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)
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)
Primary	Change in Self-Liking Scale/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)
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)
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)
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)
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)
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)
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)
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)
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)
Secondary	Change in Patient Health Questionnaire A	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)
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)
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)
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)
Secondary	Change in COVID-19 impact	Self-report measure of COVID-19 negative and positive life impact	Baseline, midway, post-intervention (10 weeks after baseline)