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Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663754
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Oregon Research Institute

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 22, 2008
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE March 2005
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
Eating Disorder Diagnostic Interview [ Time Frame: Measured at baseline, post-treatment, Month 6, and Years 1 and 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00663754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Dissonance-Based Eating Disorder Prevention Program (The Body Project II)
Official Title  ICMJE Eating Disorder Prevention Program Effectiveness Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Eating Disorders
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: Educational brochure
    Participants will receive a mailed educational brochure about a healthy body image only.
Study Arms  ICMJE
  • Active Comparator: 1
    Participants will receive a mailed brochure about body image only.
    Intervention: Behavioral: Educational brochure
  • Active Comparator: 2
    Participants will receive the 4-hour dissonance-based eating disorder prevention program.
    Intervention: Behavioral: Dissonance-based eating disorder prevention program
  • Experimental: 3
    Participants will receive the 8-hour dissonance-based eating disorder prevention program.
    Intervention: Behavioral: Dissonance-based eating disorder prevention program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2008)
306
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00663754
Other Study ID Numbers  ICMJE R01MH070699( U.S. NIH Grant/Contract )
R01MH070699 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Research Institute
Study Sponsor  ICMJE Oregon Research Institute
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Eric Stice Oregon Research Institute
Principal Investigator: Paul Rhode Oregon Research Institute
PRS Account Oregon Research Institute
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP