Eating Disorders Programs: An Indicated Trial

Eating Disorders Clinical Trial

Official title:

Eating Disorders Programs: An Indicated Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259347
• Other study ID #: IndPrevPilot
• Secondary ID: 1R01MH086582-01A
• Status: Completed
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: April 1, 2018

Study information

• Verified date: May 2018
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of two body acceptance programs for women. Participants may experience reduction of eating pathology and prevention of future obesity and eating disorders; may derive a sense of altruism and contribution to furthering understanding of a public health problem.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Participant indicates sub-threshold or threshold eating disorder.

• Participant is available to participate in the intervention sessions.

• Participants must be MRI eligible.

Exclusion Criteria:

• Participant does not indicate sub-threshold or threshold eating disorder.

• Participant is unable to attend intervention sessions.

• Participant cannot participate if MRI ineligible.

Related Conditions & MeSH terms

• Body Image
• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Group-based Therapy
Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.

Locations

Country	Name	City	State
United States	The University of Texas	Austin	Texas
United States	Oregon Research Institute	Eugene	Oregon
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months	Evaluate change (if any) by using the Eating Disorder Examination questionnaire at the 8 week and 6 month mark.	Measured at baseline, week 8, and Month 6
Secondary	Assessments using Ideal-Body Stereotype Scale-Revised	Evaluate the participants' perception of the ideal-body stereotype	Measured at baseline, week 8, and Month 6
Secondary	Assessments using Satisfaction and Dissatisfaction with Body Parts Scale	Evaluate participants' level of satisfaction and dissatisfaction with specific parts of their bodies	Measured at baseline, week 8, and Month 6
Secondary	Assessments using Dutch Restrained Eating Scale	Evaluate participants ability to exercise restraint in regards to food	Measured at baseline, week 8, and Month 6
Secondary	Assessments using Positive Affect and Negative Affect Scale-Revised	Measure participants' affect and monitor any changes that may occur.	Measured at baseline, week 8, and Month 6
Secondary	Assessments using Beliefs About Appearance Scale	Evaluate participants' perceptions and beliefs on physical appearance.	Measured at baseline, week 8, and Month 6