Eating Disorders in AdolescenceNCT04263155
The Peer-Delivered Body Project for Young Women in High School
A study testing The Body Project 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 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). 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?
- The Body Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Mar 2020
- 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
- Female high school student
Who cannot join
- Previous participation in the Body Project program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorders in Adolescence
- Being tested
- The Body Project
- Keywords
- Eating disorder prevention, Body Project, Female, Adolescence, Peer delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Body ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: The Body Project for high school young women | Experimental | The 4-hour Body Project workshop delivered by trained peer leaders Receives: Behavioral: The Body Project |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Thin-Ideal Internalization Scale
Self-report measure of endorsement of the thin ideal (scale 1-5 with higher scores indicating higher levels of thin ideal internalization)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Satisfaction and Dissatisfaction with Body Parts Scale
Self-report measure of body dissatisfaction (scale 1-5 with higher scores indicating higher levels of dissatisfaction)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Dutch Restrained Eating Scale
Self-report measure of dietary restraint (scale 1-5 with higher scores indicating higher levels of eating restraint)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Positive Affect and Negative Affect Scale-Revised
Self-report measure of negative affect (scale 1-5 with higher scores indicating higher levels of negative affect)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Secondary outcomes (13)
Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
Self-report measure of body monitoring and surveillance (scale 1-7 with higher scores indicating higher levels of body surveillance)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in UCLA Loneliness Scale
Self-report measure of loneliness (scale 1-4 with higher scores indicating higher levels of loneliness)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Inventory of Peer Influence on Eating Concerns
Self-report measure of peer influence on eating and body concerns (scale 1-5 with higher scores indicating higher levels of peer influence)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Patient Health Questionnaire (PHQ-9)
Self-report measure for depressive symptom severity(scale 0-3 with higher scores indicating higher levels of depression)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Generalized Anxiety Disorder (GAD-7)
Self-report measure for symptoms of generalized anxiety (scale 0-3 with higher scores indicating higher levels of anxiety)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in General Self-Efficacy Scale
Self-report measure of self-efficacy (scale 1-4 with higher scores indicating higher levels of self-efficacy)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Self-Compassion Scale
Self-report measure of self-compassion (scale 1-5 with higher scores indicating higher levels of self-compassion)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Change in Rosenberg Self-Esteem Scale
Self-report measure of global self-worth (scale 1-4 with higher scores indicating higher levels of self-esteem)
Measured: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up
Sense of Belonging (Body Project group only)
Self-report measure of anticipated belonging with group (scale 1-7 with higher scores indicating higher levels of anticipated belonging)
Measured: Baseline
Sense of Belonging Follow-Up (Body Project group only)
Self-report measure of belonging with group (scale 1-7 with higher scores indicating higher levels of experienced belonging)
Measured: Post-intervention (4 weeks after baseline)
Working Alliance Inventory (Body Project group only)
Self-report measure of therapeutic alliance with peer leaders (scale 1-5 with higher scores indicating higher levels of working alliance)
Measured: Post-intervention (4 weeks after baseline)
Program Satisfaction (Body Project group only)
Self-reported ratings of satisfaction with program and peer leaders (scale 1-4 with higher scores indicating higher levels of program satisfaction)
Measured: Post-intervention (4 weeks after baseline)
Fidelity and Competence (Body Project group only)
Observer-rated assessments of peer leader fidelity and competence (scale 1-10 with higher scores indicating higher levels of facilitator fidelity and competence)
Measured: From the first Body Project session to the final (fourth) Body Project session, 4 weeks on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Aug 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 74 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
- NCT04263155
- Sponsor's protocol ID
- 18-0007-01
- Status last verified
- Jun 2020
- First submitted
- 29 Jan 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanderkruik R, Gist D, Dimidjian S. Preventing eating disorders in young women: An RCT and mixed-methods evaluation of the peer-delivered Body Project. J Consult Clin Psychol. 2020 Dec;88(12):1105-1118. doi: 10.1037/ccp0000609.
PubMed 33370134
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of the Peer-Delivered Body Project for Young Women in High School
- ClinicalTrials.gov ID
- NCT04263155
- Acronym / sponsor ID
- 18-0007-01
- Conditions
- Eating Disorders in Adolescence
- Keywords
- Eating disorder prevention, Body Project, Female, Adolescence, Peer delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Feb 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: The Body Project for high school young women | Experimental | Behavioral: The Body ProjectThe 4-hour Body Project workshop delivered by trained peer leaders |
| Control | No intervention | –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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female high school student
Key exclusion criteria (1 listed)
- Previous participation in the Body Project program
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 |
|---|---|---|
| The Body ProjectThe 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. | Behavioural | Experimental: The Body Project for high school young women |
Primary outcome
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)
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)
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)
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)
13 secondary outcomes
Change in Objectified Body Consciousness Scale - Body Surveillance Subscale
Time frame: 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
Change in Inventory of Peer Influence on Eating Concerns
Time frame: 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
Change in Generalized Anxiety Disorder (GAD-7)
Time frame: 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
Change in Self-Compassion Scale
Time frame: 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
Sense of Belonging (Body Project group only)
Time frame: Baseline
Sense of Belonging Follow-Up (Body Project group only)
Time frame: Post-intervention (4 weeks after baseline)
Working Alliance Inventory (Body Project group only)
Time frame: Post-intervention (4 weeks after baseline)
Program Satisfaction (Body Project group only)
Time frame: 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
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 26 Jun 2020.
- Derived from this study: PubMed 33370134Vanderkruik R, Gist D, Dimidjian S. Preventing eating disorders in young women: An RCT and mixed-methods evaluation of the peer-delivered Body Project. J Consult Clin Psychol. 2020 Dec;88(12):1105-1118. doi: 10.1037/ccp0000609.
- Individual participant dataSharing planned: No
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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 The Body Project 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 26 Jun 2020. 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 Thin-Ideal Internalization Scale (time frame: Baseline, Post-intervention (4 weeks after baseline), 1 year post-intervention follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263155, which also lists 1 linked publication.
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 26 Jun 2020.