NCT01949649

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

September 17, 2013

Last Update Submit

April 17, 2019

Conditions

Eating Disorder Prevention

Keywords

body imagebody dissatisfaction

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups

Other Outcomes (1)

  • Change over time: Body Dissatisfaction

    baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups

Study Arms (4)

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.

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.

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.

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.

Behavioral: Education Video

Interventions

Peer-Led Group InterventionBEHAVIORAL
Peer-Led Group Intervention
Internet-Based InterventionBEHAVIORAL
Internet-Based Intervention
Clinician-Led Group InterventionBEHAVIORAL
Clinician-Led Group Intervention
Education VideoBEHAVIORAL
Education Video

Eligibility Criteria

Age17 Years - 22 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Body image concerns
  • Attend University of Oregon, Oregon State University, University of Texas at Austin, or Southwestern University

You may not qualify if:

  • Meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oregon Research Institute

Corvallis, Oregon, 97330, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (20)

  • 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.

    PMID: 19803563BACKGROUND

  • Stice 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.

    PMID: 21707136BACKGROUND

  • Stice 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.

    PMID: 22122289BACKGROUND

  • Stice 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.

    PMID: 22506791BACKGROUND

  • Hudson 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.

    PMID: 16815322BACKGROUND

  • Stice 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.

    PMID: 23148784BACKGROUND

  • Wade 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.

    PMID: 16476129BACKGROUND

  • Fairburn CG, Harrison PJ. Eating disorders. Lancet. 2003 Feb 1;361(9355):407-16. doi: 10.1016/S0140-6736(03)12378-1.

    PMID: 12573387BACKGROUND

  • Crow 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.

    PMID: 19833789BACKGROUND

  • le 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.

    PMID: 16715488BACKGROUND

  • Schmidt 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.

    PMID: 18433024BACKGROUND

  • Newman 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.

    PMID: 8698949BACKGROUND

  • Striegel-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.

    PMID: 10744844BACKGROUND

  • Stice 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.

    PMID: 16649871BACKGROUND

  • 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.

    PMID: 39509183DERIVED

  • Stice 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.

    PMID: 35653756DERIVED

  • Akers L, Rohde P, Shaw H, Stice E. Cost-Effectiveness Comparison of Delivery Modalities for a Dissonance-Based Eating Disorder Prevention Program over 4-Year Follow-Up. Prev Sci. 2021 Nov;22(8):1086-1095. doi: 10.1007/s11121-021-01264-1. Epub 2021 Jun 21.

    PMID: 34152570DERIVED

  • Stice 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.

    PMID: 32534455DERIVED

  • Stice E, Rohde P, Shaw H, Gau JM. Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Effectiveness of these delivery modalities through 4-year follow-up. J Consult Clin Psychol. 2020 May;88(5):481-494. doi: 10.1037/ccp0000493. Epub 2020 Feb 24.

    PMID: 32091226DERIVED

  • Stice E, Rohde P, Shaw H, Gau JM. Clinician-led, peer-led, and internet-delivered dissonance-based eating disorder prevention programs: Acute effectiveness of these delivery modalities. J Consult Clin Psychol. 2017 Sep;85(9):883-895. doi: 10.1037/ccp0000211. Epub 2017 Apr 20.

    PMID: 28425735DERIVED

Study Officials

  • Eric Stice, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 24, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

March 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(3)