The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote
Primary Purpose
Eating Disorders in Adolescence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mind. body. voice
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders in Adolescence focused on measuring Eating disorder prevention, Peer delivery, Female, Adolescence
Eligibility Criteria
Inclusion Criteria:
- High school women, grades 9-12
Exclusion Criteria:
- Prior participation in the Body Project or mind. body. voice. RCT
Sites / Locations
- University of Colorado Boulder
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mind. body. voice.
Control
Arm Description
The 10-week mind. body. voice. program.
Assessment-only control
Outcomes
Primary Outcome Measures
Change in Body Appreciation Scale
Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
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)
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)
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)
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)
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)
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)
Change in Self-Compassion Scale
Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)
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)
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)
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)
Change in Body Dissatisfaction Scale
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction
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)
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
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)
Change in Belonging Scale
Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)
Change in Proactive Coping Scale
Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)
Secondary Outcome Measures
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)
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)
Change in School Grades and Attendance
Self-report measure of grades and attendance
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)
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)
Change in Patient Health Questionnaire A
Self-report measure of depression (scale 1-4 with higher scores indicating higher levels of depression)
Change in UCLA Loneliness Scale
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
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)
Change in Generalized Anxiety Disorder 7
Self-report measure of anxiety (scale 1-4 with higher scores indicating higher levels of anxiety)
Change in COVID-19 impact
Self-report measure of COVID-19 negative and positive life impact
Full Information
NCT ID
NCT04591912
First Posted
October 10, 2020
Last Updated
May 15, 2023
Sponsor
University of Colorado, Boulder
1. Study Identification
Unique Protocol Identification Number
NCT04591912
Brief Title
The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote
Official Title
Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women - Remote
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders in Adolescence
Keywords
Eating disorder prevention, Peer delivery, Female, Adolescence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mind. body. voice.
Arm Type
Experimental
Arm Description
The 10-week mind. body. voice. program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment-only control
Intervention Type
Behavioral
Intervention Name(s)
mind. body. voice
Other Intervention Name(s)
Healthy Body, Mind, and Voice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Appreciation Scale
Description
Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Engaged Living Scale
Description
Self-report measure of values-based living (scale 1-5 with higher scores indicating higher levels of living based on values)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Multidimensional Assessment of Interoceptive Awareness
Description
Self-report measure of somatic awareness (scale 1-5 with higher scores indicating higher levels of somatic awareness)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Social Contribution Scale
Description
Self-report measure of sense of contributing to society (scale 1-5 with higher scores indicating higher levels of contribution)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Sociocultural Pressures Around Appearance
Description
Self-report measure of sociocultural pressures related to appearance (scale 1-5 with higher scores indicating higher levels of pressure)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Internalization of Media Appearance Ideals
Description
Self-report measure of internalized appearance ideals in the media (scale 1-5 with higher scores indicating higher levels of internalization)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Ideal Body Stereotype Scale
Description
Self-report measure of internalization of ideal body stereotypes (scale 1-5 with higher scores indicating higher levels of internalization)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Self-Compassion Scale
Description
Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Group Belonging Scale
Description
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)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Peer Influence on Appearance Concerns
Description
Self-report measure of influence of peers on appearance concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Dieting Behavior and Restraint
Description
Self-report measure of dieting behavior and restricted eating (scale 1-5 with higher scores indicating higher levels of dieting and restriction)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Body Dissatisfaction Scale
Description
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Objectified Body Consciousness Scale
Description
Self-report measure of body monitoring and surveillance (scale 1-5 with higher scores indicating higher levels of body surveillance)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Self-Liking Scale/Self-Competence Scale
Description
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
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Self-Efficacy Scale
Description
Self-report measure of effectiveness in handling challenges and achieving goals (scale 1-5 with higher scores indicating higher levels of self-efficacy)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Belonging Scale
Description
Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Proactive Coping Scale
Description
Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Secondary Outcome Measure Information:
Title
Change in Eating Attitudes Test 26
Description
Self-report measure of disordered eating behaviors (scale 1-6 with higher scores indicating higher levels of disordered eating)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in School Engagement and Belonging
Description
Self-report measure of engagement with schoolwork and belonging in school (scale 1-5 with higher scores indicating higher levels of engagement and belonging)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in School Grades and Attendance
Description
Self-report measure of grades and attendance
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Physical Health Questionnaire
Description
Self-report measure of health outcomes such as sleep and physical symptoms (scale 1-7 with higher scores indicating higher levels of health symptoms)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Positive and Negative Affect Scale
Description
Self-report measure of positive and negative affect (scale 1-6 with higher scores indicating higher affect levels)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Patient Health Questionnaire A
Description
Self-report measure of depression (scale 1-4 with higher scores indicating higher levels of depression)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in UCLA Loneliness Scale
Description
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Humanitarian Egalitarian Scale
Description
Self-report measure of agreement with humanitarian and egalitarian values (scale 1-5 with higher scores indicating higher levels of agreement)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in Generalized Anxiety Disorder 7
Description
Self-report measure of anxiety (scale 1-4 with higher scores indicating higher levels of anxiety)
Time Frame
Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Title
Change in COVID-19 impact
Description
Self-report measure of COVID-19 negative and positive life impact
Time Frame
Baseline, midway, post-intervention (10 weeks after baseline)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identify as female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
High school women, grades 9-12
Exclusion Criteria:
Prior participation in the Body Project or mind. body. voice. RCT
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote
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