Eating Disorders in AdolescenceNCT04591912
The Peer-Delivered "Mind. Body. Voice." Program for High School Women (Mbv) - Remote
A study testing mind. body. voice in people with Eating Disorders in Adolescence, run by University of Colorado, Boulder at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders in Adolescence
- What is being tested?
- mind. body. voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- High school women, grades 9-12
Who cannot join
- Prior participation in the Body Project or mind. body. voice. RCT
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women - Remote
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.
Read the 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.
- Conditions
- Eating Disorders in Adolescence
- Being tested
- mind. body. voice
- Keywords
- Eating disorder prevention, Peer delivery, Female, Adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mind. body. voiceBehavioural
Also called Healthy Body, Mind, and 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.
| Study group | Role | What they receive |
|---|---|---|
| mind. body. voice. | Experimental | The 10-week mind. body. voice. program. Receives: Behavioral: mind. body. voice |
| Control | No intervention | Assessment-only control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Appreciation Scale
Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Secondary outcomes (10)
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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in School Grades and Attendance
Self-report measure of grades and attendance
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Patient Health Questionnaire A
Self-report measure of depression (scale 1-4 with higher scores indicating higher levels of depression)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in UCLA Loneliness Scale
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Generalized Anxiety Disorder 7
Self-report measure of anxiety (scale 1-4 with higher scores indicating higher levels of anxiety)
Measured: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in COVID-19 impact
Self-report measure of COVID-19 negative and positive life impact
Measured: Baseline, midway, post-intervention (10 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start9 Oct 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorders in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sona Dimidjian, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591912
- Sponsor's protocol ID
- 18-0007-03
- Status last verified
- May 2023
- First submitted
- 10 Oct 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Peer-Delivered "Mind. Body. Voice." Eating Disorder Prevention Program Among High School Women - Remote
- ClinicalTrials.gov ID
- NCT04591912
- Acronym / sponsor ID
- 18-0007-03
- Conditions
- Eating Disorders in Adolescence
- Keywords
- Eating disorder prevention, Peer delivery, Female, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mind. body. voice. | Experimental | Behavioral: mind. body. voiceThe 10-week mind. body. voice. program. |
| Control | No intervention | –Assessment-only control |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- High school women, grades 9-12
Key exclusion criteria (1 listed)
- Prior participation in the Body Project or mind. body. voice. RCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mind. body. voiceAlso: Healthy Body, Mind, and VoiceThe mbv program consists of 10 weekly sessions that include a variety of practices, including: cognitive dissonance exercises, contemplative practices, guided discussion and community building. | Behavioural | mind. body. voice. |
Primary outcome
Change in Body Appreciation Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of body appreciation (scale 1-5 with higher scores indicating higher levels of appreciation)
Change in Engaged Living Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of somatic awareness (scale 1-5 with higher scores indicating higher levels of somatic awareness)
Change in Social Contribution Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of compassion for oneself (scale 1-5 with higher scores indicating higher levels of self-compassion)
Change in Group Belonging Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction
Change in Objectified Body Consciousness Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
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
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of general sense of belonging (scale 1-5 with higher scores indicating higher levels of belonging)
Change in Proactive Coping Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Self-report measure of ability to succeed (scale 1-5 with higher scores indicating higher levels of proactive coping)
10 secondary outcomes
Change in Eating Attitudes Test 26
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in School Engagement and Belonging
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in School Grades and Attendance
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Physical Health Questionnaire
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Positive and Negative Affect Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Patient Health Questionnaire A
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in UCLA Loneliness Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Humanitarian Egalitarian Scale
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in Generalized Anxiety Disorder 7
Time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)
Change in COVID-19 impact
Time frame: Baseline, midway, post-intervention (10 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mind. body. voice in people with Eating Disorders in Adolescence, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Appreciation Scale (time frame: Baseline, midway (5 weeks after baseline), post-intervention (10 weeks after baseline)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.