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

Primary Purpose

Obesity, Binge Eating Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Self-Help
Pure Self-Help
Sponsored by
Francine Rosselli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Weight gain prevention, Eating disorder, Binge eating

Eligibility Criteria

18 Years - 22 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Manchester Community College Department of Psychology
  • Wesleyan University Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Guided Self-Help

Pure Self-Help

Arm Description

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.

Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 20, 2013
Last Updated
June 24, 2013
Sponsor
Francine Rosselli
Collaborators
Wesleyan University
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1. Study Identification

Unique Protocol Identification Number
NCT01888406
Brief Title
Binge Eating Self-help Treatment for University Students
Acronym
BEST4US
Official Title
Targeting Binge Eating to Prevent Weight Gain in College Students
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francine Rosselli
Collaborators
Wesleyan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Binge Eating Disorder
Keywords
Obesity, Weight gain prevention, Eating disorder, Binge eating

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guided Self-Help
Arm Type
Experimental
Arm Description
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.
Arm Title
Pure Self-Help
Arm Type
Other
Arm Description
Participants receive self-help materials, including a book (Overcoming Binge Eating by C. Fairburn, handouts, and online resources.
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Help
Intervention Type
Behavioral
Intervention Name(s)
Pure Self-Help
Primary Outcome Measure Information:
Title
BMI
Description
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.
Time Frame
Baseline, post-intervention (8-week), and 6-month follow-up
Secondary Outcome Measure Information:
Title
Cessation of Binge Eating
Description
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).
Time Frame
Baseline, post-intervention (8-week), and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Striegel, PhD
Organizational Affiliation
Wesleyan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francine Rosselli, PhD
Organizational Affiliation
Manchester Community College
Official's Role
Study Director
Facility Information:
Facility Name
Manchester Community College Department of Psychology
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Wesleyan University Department of Psychology
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06459
Country
United States

12. IPD Sharing Statement

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Binge Eating Self-help Treatment for University Students

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