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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 20, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Binge Eating Self-help Treatment for University Students
Official Title  ICMJE Targeting Binge Eating to Prevent Weight Gain in College Students
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Binge Eating Disorder
Intervention  ICMJE
  • Behavioral: Guided Self-Help
  • Behavioral: Pure Self-Help
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Pure Self-Help
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2013)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 22 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888406
Other Study ID Numbers  ICMJE 1R15DK092768-O1A1
1R15DK092768 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francine Rosselli, Wesleyan University
Study Sponsor  ICMJE Francine Rosselli
Collaborators  ICMJE Wesleyan University
Investigators  ICMJE
Principal Investigator: Ruth Striegel, PhD Wesleyan University
Study Director: Francine Rosselli, PhD Manchester Community College
PRS Account Wesleyan University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP