- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263155
The Peer-Delivered Body Project for Young Women in High School
June 24, 2020 updated by: Sona Dimidjian, University of Colorado, Boulder
Implementation and Evaluation of the Peer-Delivered Body Project for Young Women in High School
This study will evaluate the impact of the Body Project (a dissonance-based program designed to address body image concerns and prevent eating disorders) on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up).
Young women will be recruited from two high schools and will be randomized to receive the Body Project or to the control group.
The Body Project will be facilitated by college-aged women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preventive models that can avert the onset of eating disorders and innovative delivery methods that increase engagement with care offer a promising approach to improving the mental health and wellness of young women.
This study aims to implement and evaluate the Body Project, a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders with high school young women using a peer delivery model.
This study will evaluate the impact of the Body Project on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up).
Young women will be recruited from two high schools and will be randomized to receive the Body Project program or to the control group.
The Body Project will be facilitated by college-aged young women who have been trained to deliver the Body Project.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- University of Colorado Boulder
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female high school student
Exclusion Criteria:
- Previous participation in the Body Project program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental: The Body Project for high school young women
The 4-hour Body Project workshop delivered by trained peer leaders
|
The Body Project is a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders.
The curriculum consists of written, verbal, and behavioral exercises that provide participants with the opportunity to voluntarily and publicly critique the appearance ideal.
|
|
NO_INTERVENTION: Control
The business-as-usual comparison group does not participate in the Body Project but may engage in any other programs or services they normally would
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Thin-Ideal Internalization Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of endorsement of the thin ideal (scale 1-5 with higher scores indicating higher levels of thin ideal internalization)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Satisfaction and Dissatisfaction with Body Parts Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Dutch Restrained Eating Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of dietary restraint (scale 1-5 with higher scores indicating higher levels of eating restraint)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Positive Affect and Negative Affect Scale-Revised
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of negative affect (scale 1-5 with higher scores indicating higher levels of negative affect)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of body monitoring and surveillance (scale 1-7 with higher scores indicating higher levels of body surveillance)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in UCLA Loneliness Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Inventory of Peer Influence on Eating Concerns
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of peer influence on eating and body concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure for depressive symptom severity(scale 0-3 with higher scores indicating higher levels of depression)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure for symptoms of generalized anxiety (scale 0-3 with higher scores indicating higher levels of anxiety)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in General Self-Efficacy Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of self-efficacy (scale 1-4 with higher scores indicating higher levels of self-efficacy)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Self-Compassion Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of self-compassion (scale 1-5 with higher scores indicating higher levels of self-compassion)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Change in Rosenberg Self-Esteem Scale
Time Frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
Self-report measure of global self-worth (scale 1-4 with higher scores indicating higher levels of self-esteem)
|
Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
|
|
Sense of Belonging (Body Project group only)
Time Frame: Baseline
|
Self-report measure of anticipated belonging with group (scale 1-7 with higher scores indicating higher levels of anticipated belonging)
|
Baseline
|
|
Sense of Belonging Follow-Up (Body Project group only)
Time Frame: Post-intervention (4 weeks after baseline)
|
Self-report measure of belonging with group (scale 1-7 with higher scores indicating higher levels of experienced belonging)
|
Post-intervention (4 weeks after baseline)
|
|
Working Alliance Inventory (Body Project group only)
Time Frame: Post-intervention (4 weeks after baseline)
|
Self-report measure of therapeutic alliance with peer leaders (scale 1-5 with higher scores indicating higher levels of working alliance)
|
Post-intervention (4 weeks after baseline)
|
|
Program Satisfaction (Body Project group only)
Time Frame: Post-intervention (4 weeks after baseline)
|
Self-reported ratings of satisfaction with program and peer leaders (scale 1-4 with higher scores indicating higher levels of program satisfaction)
|
Post-intervention (4 weeks after baseline)
|
|
Fidelity and Competence (Body Project group only)
Time Frame: From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average
|
Observer-rated assessments of peer leader fidelity and competence (scale 1-10 with higher scores indicating higher levels of facilitator fidelity and competence)
|
From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2018
Primary Completion (ACTUAL)
March 30, 2020
Study Completion (ACTUAL)
March 30, 2020
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (ACTUAL)
February 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0007-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders in Adolescence
-
University Hospital, RouenCompleted
-
University of Colorado, BoulderCompletedEating Disorders in AdolescenceUnited States
-
Esther NovaSpanish National Research Council (ICTAN, CSIC); FUNDACION PARA LA INVESTIGACIÓN...RecruitingEating Disorders in Adolescence | Eating Disorders in ChildrenSpain
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
King's College LondonSouth London and Maudsley NHS Foundation Trust; South West London and St George... and other collaboratorsUnknownEating Disorders in AdolescenceUnited Kingdom
-
University of ValenciaMinistry of Science and InnovationCompleted
-
University of Colorado, BoulderCompletedEating Disorders in AdolescenceUnited States
-
McMaster UniversityCompletedEating Disorders | Eating Disorders in AdolescenceCanada
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatedBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Ege UniversityRecruitingBody Image | Eating Behavior | Nutrition, Healthy | Eating Habit | Nutrition Disorders in AdolescenceTurkey
Clinical Trials on The Body Project
-
University of CalgaryCompletedBody-dissatisfactionCanada
-
Florida State UniversityCompleted
-
Susan GambergQueen Elizabeth II Health Sciences Centre FoundationRecruitingBody Image | Body Dissatisfaction | Dietary Restraint | Negative AffectCanada
-
Cornell CollegeNational Institute of Mental Health (NIMH)Completed
-
University of SheffieldPrincess Nourah Bint Abdulrahman UniversityCompletedEating Disorder Symptom and Body Image DissatisfactionSaudi Arabia
-
Ostfold University CollegeOslo University Hospital; Norwegian School of Sport SciencesCompletedAthletic Injuries | Eating Disorders | Adolescent - Emotional Problem | Body Dissatisfaction | Disordered EatingNorway
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Overweight | Body ImageUnited States
-
Oregon Research InstituteUniversity of Texas at Austin; Drexel UniversityCompletedObesity | Eating DisordersUnited States
-
Aarhus University HospitalAalborg Psychiatric HospitalNot yet recruitingPsychiatric Disorder | Eating Disorders | Body Dissatisfaction | Eating Disorder Symptom and Body Image DissatisfactionDenmark
-
Oslo University HospitalThe Dam Foundation; Norwegian Diabetes AssociationTerminatedFeeding and Eating Disorders | Diabetes Mellitus, Type 1 | Body ImageNorway