- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663754
Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)
Eating Disorder Prevention Program Effectiveness Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Oregon Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-reported body image concerns
Exclusion Criteria:
- Meets diagnostic and statistical manual (DSM-IV) criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Participants will receive a mailed brochure about body image only.
|
Participants will receive a mailed educational brochure about a healthy body image only.
|
|
ACTIVE_COMPARATOR: 2
Participants will receive the 4-hour dissonance-based eating disorder prevention program.
|
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.
|
|
EXPERIMENTAL: 3
Participants will receive the 8-hour dissonance-based eating disorder prevention program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eating Disorder Diagnostic Interview
Time Frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2
|
Measured at baseline, post-treatment, Month 6, and Years 1 and 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Measured at baseline, post-treatment, Month 6, and Years 1 and 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Stice, Oregon Research Institute
- Principal Investigator: Paul Rhode, Oregon Research Institute
Publications and helpful links
General Publications
- 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.
- Stice 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH070699 (NIH)
- DSIR 84-CTP (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders
-
Ibn Haldun UniversityCompletedDisordered Eating Behaviors | Eating Pathology | Eating Disorders SymptomsTurkey
-
Ibn Haldun UniversityActive, not recruitingDisordered Eating Behaviors | Eating Pathology | Eating Disorder SymptomsTurkey
-
University of PalermoUniversity of Padova; University of CatanzaroRecruitingEating Disorders | Eating Behavior | Eating Disorder SymptomItaly
-
Axsome Therapeutics, Inc.Enrolling by invitationBinge-Eating DisorderUnited States
-
BioprojetCompleted
-
Axsome Therapeutics, Inc.RecruitingBinge-Eating DisorderUnited States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedBinge-Eating DisorderUnited States
-
Ali RezaiActive, not recruiting
-
Bezmialem Vakif UniversityMuğla Sıtkı Koçman University; The Scientific and Technological Research Council... and other collaboratorsActive, not recruitingEating Disorders | Eating Behavior | Orthodontic Appliance Complication | Eating HabitTurkey
-
University of Sao Paulo General HospitalActive, not recruitingBinge Eating DisorderBrazil
Clinical Trials on Educational brochure
-
Milton S. Hershey Medical CenterCompletedChemotherapy Effect | Chemotherapeutic Toxicity | Chemotherapeutic Agent ToxicityUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingBreast Cancer | Breast Cancer MetastaticUnited States
-
University Health Network, TorontoEnrolling by invitationParkinson Disease | Dementia | Alzheimer Disease | Vascular Dementia | Frontotemporal Lobar Degeneration | Neuro-Degenerative Disease | Caregiver BurnoutCanada
-
Western Kentucky UniversityRecruitingPregnancy Related | PostpartumUnited States
-
University of Colorado, DenverThe Henry J. Kaiser Family FoundationCompletedColonoscopy | Mass ScreeningUnited States
-
Medical College of WisconsinVersiti; Healthier Wisconsin Partnership Program; National Anemia Action CouncilCompletedAnemia | Colorectal CancerUnited States
-
VA Office of Research and DevelopmentMinneapolis Veterans Affairs Medical Center; Indiana University; White River... and other collaboratorsNot yet recruitingPTSD | Anxiety | Diagnoses of DepressionUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteCompleted
-
Mayo ClinicTerminatedPatient Education in Radiation OncologyUnited States
-
Mayo ClinicNational Institute on Minority Health and Health Disparities (NIMHD); Mountain...CompletedBreast CancerUnited States