Binge Eating Self-help Treatment for University Students (BEST4US)
|ClinicalTrials.gov Identifier: NCT01888406|
Recruitment Status : Unknown
Verified June 2013 by Francine Rosselli, Wesleyan University.
Recruitment status was: Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obesity Binge Eating Disorder||Behavioral: Guided Self-Help Behavioral: Pure Self-Help||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Targeting Binge Eating to Prevent Weight Gain in College Students|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Guided Self-Help
Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources. In addition, participants receive 8 individual sessions with a peer coach who supports participants in working the self-help program.
Behavioral: Guided Self-Help
Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources.
Behavioral: Pure Self-Help
- BMI [ Time Frame: Baseline, post-intervention (8-week), and 6-month follow-up ]The primary outcome measure is change in BMI from randomization. Height and weight will be measured by study staff at the baseline visit using a stadiometer (collecting height measures twice and reporting the average) and a calibrated scale (light clothing, street shoes removed). BMI will be calculated as weight in kilograms divided by height in squared centimeters. Weight will be re-measured at 8 week- and 6 month assessments. BMI change is a primary-, and incidence of obesity (i.e., obesity onset since baseline, BMI > 30) is a secondary outcome variable. While we assess weight at the post-treatment assessment, the key question of our study is whether the intervention will reduce excess weight gain at 6-month follow-up.
- Cessation of Binge Eating [ Time Frame: Baseline, post-intervention (8-week), and 6-month follow-up ]Binge eating is assessed by clinical interview using an abbreviated version of the Eating Disorders Examination (EDE-16e) at baseline, post-treatment (8-week), and 6-month follow-up. Specifically, the EDE sections on 7-day meal patterns, overeating episodes, and the frequency of inappropriate compensatory behaviors will be administered. The key question of our study is whether the intervention will eliminate binge eating at 6-month follow-up (no reported binge eating episodes in the 28 days prior to the 6-month follow-up).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888406
|United States, Connecticut|
|Manchester Community College Department of Psychology|
|Manchester, Connecticut, United States, 06040|
|Wesleyan University Department of Psychology|
|Middletown, Connecticut, United States, 06459|
|Principal Investigator:||Ruth Striegel, PhD||Wesleyan University|
|Study Director:||Francine Rosselli, PhD||Manchester Community College|