NCT04591886

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

October 10, 2020

Last Update Submit

November 15, 2021

Conditions

Keywords

Eating disorder preventionFemaleAdolescencePeer delivery

Outcome Measures

Primary Outcomes (17)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Change in Eating Disorder Symptoms and Diagnoses

    baseline, post-intervention (10 weeks after baseline),

  • Change in Eating Attitudes Test 26

    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

    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

    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

    baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline), 6-month post intervention follow-up, 1-year post intervention follow-up

  • +5 more secondary outcomes

Study Arms (2)

mind. body. voice.

EXPERIMENTAL

The 10-week mind. body. voice. program

Behavioral: mind. body. voice.

Control

NO INTERVENTION

Assessment-only control

Interventions

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.

mind. body. voice.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsidentify as female
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High school women, grades 9-12

You may not qualify if:

  • Prior participation in the Body Project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 10, 2020

First Posted

October 19, 2020

Study Start

September 1, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations