Clinical trial NCT01949649: Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered
Official title: Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered (Formerly: Effectiveness Trial of Peer-Led Dissonance Eating Disorder Prevention Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Prevention
Keywords: body image
body dissatisfaction
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 680
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change over time: Eating disorder diagnostic interview
timeFrame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2-, and 3-year follow-ups
Secondary outcomes:
measure: Change over time: Thin-ideal internalization
timeFrame: baseline obtained on intake, 1 month post intervention and 6mo-, 1-, 2-, & 3-year followups
Other outcomes:
measure: Change over time: Body Dissatisfaction
timeFrame: baseline obtained on intake, 1 month post intervention and at 6mo, 1-, 2- & 3-yr followups
Locations:
city: Corvallis
country: United States
facility: Oregon Research Institute
state: Oregon
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: Oregon Research Institute
name: Eric Stice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.