Binge Eating Self-help Treatment for University Students

Obesity Clinical Trial

— BEST4US  

Official title:

Targeting Binge Eating to Prevent Weight Gain in College Students

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01888406
• Other study ID #: 1R15DK092768-O1A1
• Status: Active, not recruiting
• Phase: N/A
• First received: June 20, 2013
• Last updated: June 24, 2013
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: Wesleyan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 22 Years

Eligibility

Inclusion Criteria:

• binge eating episodes at least once per week in the past 28 days

• 18 to 22 years old

• full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)

Exclusion Criteria:

• purging more than once per week in the past three months

• BMI less than 18 or greater than/equal to 40

• currently pregnant

• severe depressive symptoms or suicidality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Obesity

Intervention

Behavioral:
• Guided Self-Help

• Pure Self-Help

Locations

Country	Name	City	State
United States	Manchester Community College Department of Psychology	Manchester	Connecticut
United States	Wesleyan University Department of Psychology	Middletown	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Francine Rosselli	Wesleyan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	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.	Baseline, post-intervention (8-week), and 6-month follow-up	No
Secondary	Cessation of Binge Eating	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).	Baseline, post-intervention (8-week), and 6-month follow-up	No