Eating Disorder PreventionNCT01949649
Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered
A study testing Peer-Led Group Intervention, Internet-Based Intervention and Clinician-Led Group Intervention in people with Eating Disorder Prevention, run by Oregon Research Institute at 3 sites in United States.
Trial summary
Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified (ED-NOS), which includes subthreshold variants of these disorders. Read more about this study
- Who is it for?
- Ages 17 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Prevention
- What is being tested?
- Peer-Led Group Intervention, Internet-Based Intervention and Clinician-Led Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Mar 2019
- 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 17 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Body image concerns
- Attend University of Oregon, Oregon State University, University of Texas at Austin, or Southwestern University
Who cannot join
- Meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
- Suicidal ideation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas at Austin
Austin, Texas, 78712
Oregon Research Institute
Corvallis, Oregon, 97330
Oregon Research Institute
Eugene, Oregon, 97403
About this study
Official title: Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)
Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified (ED-NOS), which includes subthreshold variants of these disorders. Over half of those presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse, morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide attempts, outpatient/inpatient treatment, and functional impairment than most other psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public health priority is to develop and disseminate effective eating disorder prevention programs.
Read the detailed description
Although dozens of eating disorder prevention programs have been evaluated, only a dissonance-based program (the Body Project) has significantly reduced future onset of threshold and subthreshold eating disorders through long-term follow-up. An effectiveness trial found that the Body Project produced significant reductions in risk factors, eating disorder symptoms, and functional impairment relative to educational brochure controls, with some effects persisting through 3-yr follow-up when high school clinicians recruited students and delivered the program. These trials confirm the efficacy and effectiveness of the Body Project, but revealed a key dissemination barrier; it can be difficult to identify and recruit clinicians at high schools and colleges with the time and expertise to competently deliver the program.
One solution to this key dissemination barrier is to train students in established peer leader programs at colleges to recruit high-risk students and deliver the program. Another solution to this dissemination barrier would be to deliver the Body Project via the Internet.
Because peer-led groups and Internet delivery of the Body Project could markedly extend the reach and sustainability of this evidence-based program, we propose to conduct the first large multi-site effectiveness trial that directly compares the effects and cost effectiveness of peer-led Body Project groups, the eBody Project intervention, and clinician-led Body Project groups to an educational video control condition.
- Conditions
- Eating Disorder Prevention
- Being tested
- Peer-Led Group Intervention, Internet-Based Intervention, Clinician-Led Group Intervention, Education Video
- Keywords
- body image, body dissatisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Led Group InterventionBehavioural
Internet-Based InterventionBehavioural
Clinician-Led Group InterventionBehavioural
Education VideoBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Peer-Led Group Intervention | Active comparator | In the Peer-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by peer leaders. Receives: Behavioral: Peer-Led Group Intervention |
| Clinician-Led Group Intervention | Active comparator | In the Clinician-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by University clinicians. Receives: Behavioral: Clinician-Led Group Intervention |
| Internet-Based Intervention | Active comparator | The Internet-Based Intervention consists of 6 40-min modules involving user-driven self-education activities and games (e.g., role-plays), writing/video contests, and off-line exercises designed to induce dissonance regarding pursuit of the thin-ideal, mirroring activities from the group Body Project. Receives: Behavioral: Internet-Based Intervention |
| Education Video | Active comparator | The Education Video describes eating disorders, their adverse effects, and the need for treatment, which is key information to provide to young women at elevated risk for eating disorders due to body dissatisfaction. Receives: Behavioral: Education Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time: Eating disorder diagnostic interview
Participants will complete an interview assessing Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) eating disorder symptoms.
Measured: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups
Secondary outcomes (1)
Change over time: Thin-ideal internalization
Thin-ideal internalization will be assessed with the 8-item Ideal-Body Stereotype Scale-Revised. Participants respond using a 5-point response format.
Measured: baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder PreventionStudies 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
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Stice, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949649
- Sponsor's protocol ID
- MH097720
- Status last verified
- Apr 2019
- First submitted
- 17 Sep 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stice E, Rohde P, Gau J, Shaw H. An effectiveness trial of a dissonance-based eating disorder prevention program for high-risk adolescent girls. J Consult Clin Psychol. 2009 Oct;77(5):825-34. doi: 10.1037/a0016132.
PubMed 19803563Stice E, Rohde P, Shaw H, Gau J. An effectiveness trial of a selected dissonance-based eating disorder prevention program for female high school students: Long-term effects. J Consult Clin Psychol. 2011 Aug;79(4):500-8. doi: 10.1037/a0024351.
PubMed 21707136Stice E, Rohde P, Shaw H, Marti CN. Efficacy trial of a selective prevention program targeting both eating disorder symptoms and unhealthy weight gain among female college students. J Consult Clin Psychol. 2012 Feb;80(1):164-170. doi: 10.1037/a0026484. Epub 2011 Nov 28.
PubMed 22122289Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
PubMed 22506791Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3.
PubMed 16815322Stice E, Marti CN, Rohde P. Prevalence, incidence, impairment, and course of the proposed DSM-5 eating disorder diagnoses in an 8-year prospective community study of young women. J Abnorm Psychol. 2013 May;122(2):445-57. doi: 10.1037/a0030679. Epub 2012 Nov 12.
PubMed 23148784Wade TD, Bergin JL, Tiggemann M, Bulik CM, Fairburn CG. Prevalence and long-term course of lifetime eating disorders in an adult Australian twin cohort. Aust N Z J Psychiatry. 2006 Feb;40(2):121-8. doi: 10.1080/j.1440-1614.2006.01758.x.
PubMed 16476129Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.
PubMed 12573387Crow SJ, Peterson CB, Swanson SA, Raymond NC, Specker S, Eckert ED, Mitchell JE. Increased mortality in bulimia nervosa and other eating disorders. Am J Psychiatry. 2009 Dec;166(12):1342-6. doi: 10.1176/appi.ajp.2009.09020247. Epub 2009 Oct 15.
PubMed 19833789le Grange D, Binford RB, Peterson CB, Crow SJ, Crosby RD, Klein MH, Bardone-Cone AM, Joiner TE, Mitchell JE, Wonderlich SA. DSM-IV threshold versus subthreshold bulimia nervosa. Int J Eat Disord. 2006 Sep;39(6):462-7. doi: 10.1002/eat.20304.
PubMed 16715488Schmidt U, Lee S, Perkins S, Eisler I, Treasure J, Beecham J, Berelowitz M, Dodge L, Frost S, Jenkins M, Johnson-Sabine E, Keville S, Murphy R, Robinson P, Winn S, Yi I. Do adolescents with eating disorder not otherwise specified or full-syndrome bulimia nervosa differ in clinical severity, comorbidity, risk factors, treatment outcome or cost? Int J Eat Disord. 2008 Sep;41(6):498-504. doi: 10.1002/eat.20533.
PubMed 18433024Newman DL, Moffitt TE, Caspi A, Magdol L, Silva PA, Stanton WR. Psychiatric disorder in a birth cohort of young adults: prevalence, comorbidity, clinical significance, and new case incidence from ages 11 to 21. J Consult Clin Psychol. 1996 Jun;64(3):552-62.
PubMed 8698949Striegel-Moore RH, Leslie D, Petrill SA, Garvin V, Rosenheck RA. One-year use and cost of inpatient and outpatient services among female and male patients with an eating disorder: evidence from a national database of health insurance claims. Int J Eat Disord. 2000 May;27(4):381-9. doi: 10.1002/(sici)1098-108x(200005)27:43.0.co;2-u.
PubMed 10744844Stice E, Shaw H, Burton E, Wade E. Dissonance and healthy weight eating disorder prevention programs: a randomized efficacy trial. J Consult Clin Psychol. 2006 Apr;74(2):263-75. doi: 10.1037/0022-006X.74.2.263.
PubMed 16649871Stice 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 39509183
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)
- ClinicalTrials.gov ID
- NCT01949649
- Acronym / sponsor ID
- MH097720
- Conditions
- Eating Disorder Prevention
- Keywords
- body image, body dissatisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 24 Sep 2013 (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.
Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified (ED-NOS), which includes subthreshold variants of these disorders. Over half of those presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse, morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide attempts, outpatient/inpatient treatment, and functional impairment than most other psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public health priority is to develop and disseminate effective eating disorder prevention programs.
Detailed description
Although dozens of eating disorder prevention programs have been evaluated, only a dissonance-based program (the Body Project) has significantly reduced future onset of threshold and subthreshold eating disorders through long-term follow-up. An effectiveness trial found that the Body Project produced significant reductions in risk factors, eating disorder symptoms, and functional impairment relative to educational brochure controls, with some effects persisting through 3-yr follow-up when high school clinicians recruited students and delivered the program. These trials confirm the efficacy and effectiveness of the Body Project, but revealed a key dissemination barrier; it can be difficult to identify and recruit clinicians at high schools and colleges with the time and expertise to competently deliver the program.
One solution to this key dissemination barrier is to train students in established peer leader programs at colleges to recruit high-risk students and deliver the program. Another solution to this dissemination barrier would be to deliver the Body Project via the Internet.
Because peer-led groups and Internet delivery of the Body Project could markedly extend the reach and sustainability of this evidence-based program, we propose to conduct the first large multi-site effectiveness trial that directly compares the effects and cost effectiveness of peer-led Body Project groups, the eBody Project intervention, and clinician-led Body Project groups to an educational video control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peer-Led Group Intervention | Active comparator | Behavioral: Peer-Led Group InterventionIn the Peer-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by peer leaders. |
| Clinician-Led Group Intervention | Active comparator | Behavioral: Clinician-Led Group InterventionIn the Clinician-Led Group Intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique the thin-ideal ideal during 4 1-hr sessions and in homework activities which are led by University clinicians. |
| Internet-Based Intervention | Active comparator | Behavioral: Internet-Based InterventionThe Internet-Based Intervention consists of 6 40-min modules involving user-driven self-education activities and games (e.g., role-plays), writing/video contests, and off-line exercises designed to induce dissonance regarding pursuit of the thin-ideal, mirroring activities from the group Body Project. |
| Education Video | Active comparator | Behavioral: Education VideoThe Education Video describes eating disorders, their adverse effects, and the need for treatment, which is key information to provide to young women at elevated risk for eating disorders due to body dissatisfaction. |
Who may qualify
- Ages
- 17 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Body image concerns
- Attend University of Oregon, Oregon State University, University of Texas at Austin, or Southwestern University
Key exclusion criteria (2 listed)
- Meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
- Suicidal ideation
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 |
|---|---|---|
| Peer-Led Group Intervention | Behavioural | Peer-Led Group Intervention |
| Internet-Based Intervention | Behavioural | Internet-Based Intervention |
| Clinician-Led Group Intervention | Behavioural | Clinician-Led Group Intervention |
| Education Video | Behavioural | Education Video |
Primary outcome
Change over time: Eating disorder diagnostic interview
Time frame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups
Participants will complete an interview assessing Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) eating disorder symptoms.
1 secondary outcome
Change over time: Thin-ideal internalization
Time frame: baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups
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 18 Apr 2019.
- Background: PubMed 19803563Stice E, Rohde P, Gau J, Shaw H. An effectiveness trial of a dissonance-based eating disorder prevention program for high-risk adolescent girls. J Consult Clin Psychol. 2009 Oct;77(5):825-34. doi: 10.1037/a0016132.
- Background: PubMed 21707136Stice E, Rohde P, Shaw H, Gau J. An effectiveness trial of a selected dissonance-based eating disorder prevention program for female high school students: Long-term effects. J Consult Clin Psychol. 2011 Aug;79(4):500-8. doi: 10.1037/a0024351.
- Background: PubMed 22122289Stice E, Rohde P, Shaw H, Marti CN. Efficacy trial of a selective prevention program targeting both eating disorder symptoms and unhealthy weight gain among female college students. J Consult Clin Psychol. 2012 Feb;80(1):164-170. doi: 10.1037/a0026484. Epub 2011 Nov 28.
- Background: PubMed 22506791Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
- Background: PubMed 16815322Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3.
- Background: PubMed 23148784Stice E, Marti CN, Rohde P. Prevalence, incidence, impairment, and course of the proposed DSM-5 eating disorder diagnoses in an 8-year prospective community study of young women. J Abnorm Psychol. 2013 May;122(2):445-57. doi: 10.1037/a0030679. Epub 2012 Nov 12.
- Background: PubMed 16476129Wade TD, Bergin JL, Tiggemann M, Bulik CM, Fairburn CG. Prevalence and long-term course of lifetime eating disorders in an adult Australian twin cohort. Aust N Z J Psychiatry. 2006 Feb;40(2):121-8. doi: 10.1080/j.1440-1614.2006.01758.x.
- Background: PubMed 12573387Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.
- Background: PubMed 19833789Crow SJ, Peterson CB, Swanson SA, Raymond NC, Specker S, Eckert ED, Mitchell JE. Increased mortality in bulimia nervosa and other eating disorders. Am J Psychiatry. 2009 Dec;166(12):1342-6. doi: 10.1176/appi.ajp.2009.09020247. Epub 2009 Oct 15.
- Background: PubMed 16715488le Grange D, Binford RB, Peterson CB, Crow SJ, Crosby RD, Klein MH, Bardone-Cone AM, Joiner TE, Mitchell JE, Wonderlich SA. DSM-IV threshold versus subthreshold bulimia nervosa. Int J Eat Disord. 2006 Sep;39(6):462-7. doi: 10.1002/eat.20304.
- Background: PubMed 18433024Schmidt U, Lee S, Perkins S, Eisler I, Treasure J, Beecham J, Berelowitz M, Dodge L, Frost S, Jenkins M, Johnson-Sabine E, Keville S, Murphy R, Robinson P, Winn S, Yi I. Do adolescents with eating disorder not otherwise specified or full-syndrome bulimia nervosa differ in clinical severity, comorbidity, risk factors, treatment outcome or cost? Int J Eat Disord. 2008 Sep;41(6):498-504. doi: 10.1002/eat.20533.
- Background: PubMed 8698949Newman DL, Moffitt TE, Caspi A, Magdol L, Silva PA, Stanton WR. Psychiatric disorder in a birth cohort of young adults: prevalence, comorbidity, clinical significance, and new case incidence from ages 11 to 21. J Consult Clin Psychol. 1996 Jun;64(3):552-62.
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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, PhD principal investigator
Oregon Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Led Group Intervention, Internet-Based Intervention and Clinician-Led Group Intervention in people with Eating Disorder Prevention, run by Oregon Research Institute at 3 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 2 inclusion and 2 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change over time: Eating disorder diagnostic interview (time frame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups). 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 NCT01949649, which also lists 20 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 18 Apr 2019.