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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00042185
Other study ID # R01MH061957
Secondary ID R01MH061957DSIR
Status Completed
Phase N/A
First received July 24, 2002
Last updated September 26, 2013
Start date February 2001
Est. completion date May 2007

Study information

Verified date September 2013
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns.


Description:

Adolescent girls with body dissatisfaction (N=481; SD=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. Dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. Healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. Healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. Dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 19 Years
Eligibility Inclusion criteria:

- Self-reported body image concerns

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Dissonance Eating Disorder Prevention Program
In this intervention, participants voluntarily engaged in verbal, written, and behavioral exercises in which they critiqued the thin-ideal ideal. These exercises were conducted in sessions and in homework activities. For example, they wrote a counter-attitudinal essay about the costs associated with pursuit of the thin-ideal and engaged in a counter-attitudinal role-play in which they attempted to dissuade facilitators from pursuing the thin-ideal.
Healthy Weight Intervention
In this intervention, participants were encouraged to make gradual healthy and lasting changes to their diet and physical activity to balance their energy needs with their energy intake, and thereby achieve a healthier weight and body satisfaction. With support from the facilitator and group members, they initiated an individual lifestyle change plan to reduce intake of fat and sugar and to increase exercise using behavioral modification principles. Food and exercise diaries were used to identify behaviors to target in this lifestyle modification and to monitor change. Motivational enhancement activities were used to promote motivation for behavior change.
Expressive Writing Control Condition
In this condition, which is based on the work of Pennebaker (1997), participants wrote about emotionally significant topics in three individual weekly 45-minute sessions. They were told that research indicates that body dissatisfaction is linked to emotional issues and that expressive writing helps resolve these issues. Sample topics included relationships or goals. They were told that their work would not be read and were asked to write continuously for the duration of the session about an emotionally important topic.

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. — View Citation

Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Disorder Diagnostic Interview 1 year No
Secondary The Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Positive Affect and Negative Affect Scale-Revised 1 year No
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