NCT04591912

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
1 day 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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

October 10, 2020

Last Update Submit

May 15, 2023

Conditions

Keywords

Eating disorder preventionPeer deliveryFemaleAdolescence

Outcome Measures

Primary Outcomes (17)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (10)

  • Change in Eating Attitudes Test 26

    Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)

  • Change in School Engagement and Belonging

    Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)

  • Change in School Grades and Attendance

    Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)

  • Change in Physical Health Questionnaire

    Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)

  • Change in Positive and Negative Affect Scale

    Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)

  • +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.

Also known as: Healthy Body, Mind, and Voice
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 or mind. body. voice. RCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

MeSH Terms

Interventions

Voice

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

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

October 9, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations