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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental: The Body Project for high school young women
The 4-hour Body Project workshop delivered by trained peer leaders
Behavioral: The Body Project
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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