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Completed

NCT Number: NCT01126918

Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students

This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.

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Key information

Conditions

Eating Disorders Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Christian University, Eugene, Oregon, United States

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About this study

Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) is a registered student at a participating school, (2) self-reports body image concerns

Exclusion criteria

  • meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder

Treatment and study plan

Body Project

Behavioral

Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.

Primary outcomes

  1. eating disorder symptoms, risk for future eating disorder and obesity onset

    Time frame: 2 years

Secondary outcomes

  1. mediators to intervention effects

    Time frame: 2 years

    We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization

  2. moderators to program effects

    Time frame: 2 years

    We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • Drexel University
  • University of Texas at Austin

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
May 20, 2010
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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