- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888406
Binge Eating Self-help Treatment for University Students (BEST4US)
June 24, 2013 updated by: Francine Rosselli
Targeting Binge Eating to Prevent Weight Gain in College Students
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Manchester, Connecticut, United States, 06040
- Manchester Community College Department of Psychology
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Middletown, Connecticut, United States, 06459
- Wesleyan University Department of Psychology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 22 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
Other: Pure Self-Help
Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, post-intervention (8-week), and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, post-intervention (8-week), and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth Striegel, PhD, Wesleyan University
- Study Director: Francine Rosselli, PhD, Manchester Community College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
September 1, 2014
Study Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
June 24, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Estimate)
June 27, 2013
Last Update Submitted That Met QC Criteria
June 24, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R15DK092768-O1A1
- 1R15DK092768 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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