Eating DisordersNCT00663754
Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)
A study testing Dissonance-based eating disorder prevention program and Educational brochure in people with Eating Disorders, run by Oregon Research Institute at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Dissonance-based eating disorder prevention program and Educational brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Oct 2012
- 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Self-reported body image concerns
Who cannot join
- Meets diagnostic and statistical manual (DSM-IV) criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eating Disorder Prevention Program Effectiveness Trial
This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.
Read the detailed description
It is estimated that up to 80% of young adult women in the United States are dissatisfied with their appearance, particularly their weight. Young women's perception of the ideal body type is influenced by many factors, including peers, parents, and the media. Body dissatisfaction is associated with an increased risk of depression and eating disorders, making programs to reduce body image issues in young women important. Programs that target eating disorder prevention through promoting healthy behaviors and critiquing the thin ideal may be an effective means of increasing body satisfaction among young women. Particularly, a dissonance-based eating disorder prevention program that assesses the thin ideal through verbal, written, and behavioral exercises may be the best means of addressing body image concerns. This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.
Participation in this study will last 2 years and will involve both parent and daughter participants. Study participation for parent participants will include three 15-minute interviews conducted at baseline and Years 1 and 2. The interviews will focus on their daughters' social adjustment, performance in school, relationships with others, hobbies, and related topics. Daughter participants will still be allowed to partake in the study even if their parents do not complete all three interviews.
All potential daughter participants will first complete a 20-minute interview regarding their eating habits and mental health. Eligible participants will then be assigned to one of three programs designed to improve body image satisfaction:
- Program 1 will consist of the distribution of an educational brochure about a healthy body image.
- Program 2 will involve four 1-hour meetings during which participants will complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal.
- Program 3 will include eight 1-hour meetings during which participants will also complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and by promoting healthy eating and exercise habits.
Participants in all programs will complete brief surveys and interviews about their attitudes and behaviors at baseline, at treatment completion, and at three other points during the 2 years from baseline.
- Conditions
- Eating Disorders
- Being tested
- Dissonance-based eating disorder prevention program, Educational brochure
- Keywords
- Body Image
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissonance-based eating disorder prevention programBehavioural
Participants will engage in verbal, written, and behavioral exercises in which they will critique the thin ideal. These exercises will be conducted in sessions and in homework activities. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal.
Educational brochureBehavioural
Participants will receive a mailed educational brochure about a healthy body image only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive a mailed brochure about body image only. Receives: Behavioral: Educational brochure |
| 2 | Active comparator | Participants will receive the 4-hour dissonance-based eating disorder prevention program. Receives: Behavioral: Dissonance-based eating disorder prevention program |
| 3 | Experimental | Participants will receive the 8-hour dissonance-based eating disorder prevention program. Receives: Behavioral: Dissonance-based eating disorder prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Diagnostic Interview
Measured: Measured at baseline, post-treatment, Month 6, and Years 1 and 2
Secondary outcomes (1)
Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Dutch Restrained Eating Scale, Positive Affect and Negative Affect Scale-Revised, and Beliefs About Appearance Scale
Measured: Measured at baseline, post-treatment, Month 6, and Years 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Eric Stice, Principal investigator, Oregon Research InstitutePaul Rhode, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663754
- Sponsor's protocol ID
- R01MH070699
- Other IDs
- R01MH070699, DSIR 84-CTP
- Status last verified
- Mar 2014
- First submitted
- 21 Apr 2008
- Last updated
- 4 Mar 2014
- 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 34180702
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Disorder Prevention Program Effectiveness Trial
- ClinicalTrials.gov ID
- NCT00663754
- Acronym / sponsor ID
- R01MH070699
- Conditions
- Eating Disorders
- Keywords
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Apr 2008 (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 study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.
Detailed description
It is estimated that up to 80% of young adult women in the United States are dissatisfied with their appearance, particularly their weight. Young women's perception of the ideal body type is influenced by many factors, including peers, parents, and the media. Body dissatisfaction is associated with an increased risk of depression and eating disorders, making programs to reduce body image issues in young women important. Programs that target eating disorder prevention through promoting healthy behaviors and critiquing the thin ideal may be an effective means of increasing body satisfaction among young women. Particularly, a dissonance-based eating disorder prevention program that assesses the thin ideal through verbal, written, and behavioral exercises may be the best means of addressing body image concerns. This study will evaluate the effectiveness of dissonance-based eating disorder prevention programs in reducing body dissatisfaction among young women with body image concerns.
Participation in this study will last 2 years and will involve both parent and daughter participants. Study participation for parent participants will include three 15-minute interviews conducted at baseline and Years 1 and 2. The interviews will focus on their daughters' social adjustment, performance in school, relationships with others, hobbies, and related topics. Daughter participants will still be allowed to partake in the study even if their parents do not complete all three interviews.
All potential daughter participants will first complete a 20-minute interview regarding their eating habits and mental health. Eligible participants will then be assigned to one of three programs designed to improve body image satisfaction:
- Program 1 will consist of the distribution of an educational brochure about a healthy body image.
- Program 2 will involve four 1-hour meetings during which participants will complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal.
- Program 3 will include eight 1-hour meetings during which participants will also complete a series of verbal and written exercises. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and by promoting healthy eating and exercise habits.
Participants in all programs will complete brief surveys and interviews about their attitudes and behaviors at baseline, at treatment completion, and at three other points during the 2 years from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Educational brochureParticipants will receive a mailed brochure about body image only. |
| 2 | Active comparator | Behavioral: Dissonance-based eating disorder prevention programParticipants will receive the 4-hour dissonance-based eating disorder prevention program. |
| 3 | Experimental | Behavioral: Dissonance-based eating disorder prevention programParticipants will receive the 8-hour dissonance-based eating disorder prevention program. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Self-reported body image concerns
Key exclusion criteria (1 listed)
- Meets diagnostic and statistical manual (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 |
|---|---|---|
| Dissonance-based eating disorder prevention programParticipants will engage in verbal, written, and behavioral exercises in which they will critique the thin ideal. These exercises will be conducted in sessions and in homework activities. The exercises will aim to increase body image satisfaction by helping participants to think critically about the thin ideal and to discuss some of the problems associated with the pursuit of this ideal. | Behavioural | 2, 3 |
| Educational brochureParticipants will receive a mailed educational brochure about a healthy body image only. | Behavioural | 1 |
Primary outcome
Eating Disorder Diagnostic Interview
Time frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2
1 secondary outcome
Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Dutch Restrained Eating Scale, Positive Affect and Negative Affect Scale-Revised, and Beliefs About Appearance Scale
Time frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2
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 4 Mar 2014.
- 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.
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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 principal investigator
Oregon Research Institute
Paul Rhode principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissonance-based eating disorder prevention program and Educational brochure in people with Eating Disorders, run by Oregon Research Institute 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 4 Mar 2014. 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?
Eating Disorder Diagnostic Interview (time frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2). 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 NCT00663754, which also lists 3 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 4 Mar 2014.