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Completed

NCT Number: NCT04591886

The Peer-Delivered "Mind. Body. Voice." Program for High School Women

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.

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Key information

Conditions

Eating Disorders in Adolescence

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High school women, grades 9-12

Exclusion criteria

  • Prior participation in the Body Project

Treatment and study plan

mind. body. voice.

Behavioral

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: mbv

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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