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Binge Eating Self-help Treatment for University Students (BEST4US)

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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
Sponsor:
Collaborator:
Wesleyan University
Information provided by (Responsible Party):
Francine Rosselli, Wesleyan University

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Binge Eating Disorder Behavioral: Guided Self-Help Behavioral: Pure Self-Help Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

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.
Behavioral: Guided Self-Help
Pure Self-Help
Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources.
Behavioral: Pure Self-Help



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Connecticut
Manchester Community College Department of Psychology
Manchester, Connecticut, United States, 06040
Wesleyan University Department of Psychology
Middletown, Connecticut, United States, 06459
Sponsors and Collaborators
Francine Rosselli
Wesleyan University
Investigators
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Principal Investigator: Ruth Striegel, PhD Wesleyan University
Study Director: Francine Rosselli, PhD Manchester Community College

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Responsible Party: Francine Rosselli, Visting Scholar, Dept of Psychology; Co-Investigator, BEST4US, Wesleyan University
ClinicalTrials.gov Identifier: NCT01888406     History of Changes
Other Study ID Numbers: 1R15DK092768-O1A1
1R15DK092768 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013
Keywords provided by Francine Rosselli, Wesleyan University:
Obesity
Weight gain prevention
Eating disorder
Binge eating
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive