Eating DisordersNCT01126918
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
A study testing Body Project in people with Eating Disorders and Obesity, run by Oregon Research Institute at 7 sites in United States.
Trial summary
This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Obesity
- What is being tested?
- Body Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2010to Feb 2016
- 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
- (1) is a registered student at a participating school, (2) self-reports body image concerns
Who cannot join
- meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Texas at Austin
Austin, Texas, 78712
Northwest Christian University
Eugene, Oregon, 97401
University of Oregon
Eugene, Oregon, 97403
Southwestern University
Georgetown, Texas, 78626
Drexel University
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19122
About this study
This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.
Read the detailed description
Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.
- Conditions
- Eating Disorders, Obesity
- Being tested
- Body Project
- Keywords
- Eating Disorders, Obesity, Body Dissatisfaction, Female
- Medical subject headings
- Feeding and Eating Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body ProjectBehavioural
Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Brochure Condition | Active comparator | Participants in this condition receive an educational brochure about healthy body image via post-mail. Receives: Behavioral: Body Project |
| Group Condition | Experimental | Participants in this condition attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction. Receives: Behavioral: Body Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
eating disorder symptoms, risk for future eating disorder and obesity onset
Measured: 2 years
Secondary outcomes (2)
mediators to intervention effects
We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization
Measured: 2 years
moderators to program effects
We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, Drexel University
- Responsible party
- Sponsor
- Investigators
- Eric Stice, Ph.D., Principal investigator, Oregon Research InstituteMeghan Butryn, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126918
- Sponsor's protocol ID
- MH086582
- Status last verified
- Sep 2016
- First submitted
- 18 May 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stice E, Desjardins C, Shaw H, Siegel S, Gee K, Rohde P. Prevalence, incidence, impairment, course, and diagnostic progression and transition of eating disorders, overweight, and obesity in a large prospective study of high-risk young women. J Psychopathol Clin Sci. 2025 May;134(4):427-437. doi: 10.1037/abn0000965. Epub 2024 Nov 7.
PubMed 39509183Stice E, Desjardins CD, Rohde P. Young women who develop anorexia nervosa exhibit a persistently low premorbid body weight on average: A longitudinal investigation of an important etiologic clue. J Psychopathol Clin Sci. 2022 Jul;131(5):479-492. doi: 10.1037/abn0000762. Epub 2022 Jun 2.
PubMed 35653756Stice E, Desjardins CD, Rohde P, Shaw H. Sequencing of symptom emergence in anorexia nervosa, bulimia nervosa, binge eating disorder, and purging disorder and relations of prodromal symptoms to future onset of these disorders. J Abnorm Psychol. 2021 May;130(4):377-387. doi: 10.1037/abn0000666.
PubMed 34180702Stice E, Rohde P, Shaw H, Desjardins C. Weight suppression increases odds for future onset of anorexia nervosa, bulimia nervosa, and purging disorder, but not binge eating disorder. Am J Clin Nutr. 2020 Oct 1;112(4):941-947. doi: 10.1093/ajcn/nqaa146.
PubMed 32534455
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
- ClinicalTrials.gov ID
- NCT01126918
- Acronym / sponsor ID
- MH086582
- Conditions
- Eating Disorders, Obesity
- Keywords
- Eating Disorders, Obesity, Body Dissatisfaction, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- University of Texas at Austin, Drexel University
- Study start
- Apr 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 May 2010 (estimated)
- 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 three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.
Detailed description
Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brochure Condition | Active comparator | Behavioral: Body ProjectParticipants in this condition receive an educational brochure about healthy body image via post-mail. |
| Group Condition | Experimental | Behavioral: Body ProjectParticipants in this condition attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) is a registered student at a participating school, (2) self-reports body image concerns
Key exclusion criteria (1 listed)
- meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
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 |
|---|---|---|
| Body ProjectParticipants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction. | Behavioural | Brochure Condition, Group Condition |
Primary outcome
eating disorder symptoms, risk for future eating disorder and obesity onset
Time frame: 2 years
2 secondary outcomes
mediators to intervention effects
Time frame: 2 years
moderators to program effects
Time frame: 2 years
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 30 Sep 2016.
- Derived from this study: PubMed 39509183Stice E, Desjardins C, Shaw H, Siegel S, Gee K, Rohde P. Prevalence, incidence, impairment, course, and diagnostic progression and transition of eating disorders, overweight, and obesity in a large prospective study of high-risk young women. J Psychopathol Clin Sci. 2025 May;134(4):427-437. doi: 10.1037/abn0000965. Epub 2024 Nov 7.
- Derived from this study: PubMed 35653756Stice E, Desjardins CD, Rohde P. Young women who develop anorexia nervosa exhibit a persistently low premorbid body weight on average: A longitudinal investigation of an important etiologic clue. J Psychopathol Clin Sci. 2022 Jul;131(5):479-492. doi: 10.1037/abn0000762. Epub 2022 Jun 2.
- Derived from this study: PubMed 34180702Stice E, Desjardins CD, Rohde P, Shaw H. Sequencing of symptom emergence in anorexia nervosa, bulimia nervosa, binge eating disorder, and purging disorder and relations of prodromal symptoms to future onset of these disorders. J Abnorm Psychol. 2021 May;130(4):377-387. doi: 10.1037/abn0000666.
- Derived from this study: PubMed 32534455Stice E, Rohde P, Shaw H, Desjardins C. Weight suppression increases odds for future onset of anorexia nervosa, bulimia nervosa, and purging disorder, but not binge eating disorder. Am J Clin Nutr. 2020 Oct 1;112(4):941-947. doi: 10.1093/ajcn/nqaa146.
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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.
Eric Stice, Ph.D. principal investigator
Oregon Research Institute
Meghan Butryn, Ph.D. principal investigator
Drexel University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Project in people with Eating Disorders and Obesity, run by Oregon Research Institute at 7 sites 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
eating disorder symptoms, risk for future eating disorder and obesity onset (time frame: 2 years). 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 NCT01126918, which also lists 4 linked publications.
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 30 Sep 2016.