NCT01888406

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

June 20, 2013

Last Update Submit

June 24, 2013

Conditions

ObesityBinge Eating Disorder

Keywords

ObesityWeight gain preventionEating disorderBinge eating

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cessation of Binge Eating

    Baseline, post-intervention (8-week), and 6-month follow-up

Study Arms (2)

Guided Self-Help

EXPERIMENTAL

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

OTHER

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

Behavioral: Pure Self-Help

Interventions

Guided Self-HelpBEHAVIORAL
Guided Self-Help
Pure Self-HelpBEHAVIORAL
Pure Self-Help

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • binge eating episodes at least once per week in the past 28 days
  • to 22 years old
  • full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manchester Community College Department of Psychology

Manchester, Connecticut, 06040, United States

Location

Wesleyan University Department of Psychology

Middletown, Connecticut, 06459, United States

Location

MeSH Terms

Conditions

ObesityBinge-Eating DisorderFeeding and Eating DisordersBulimia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSigns and Symptoms, DigestiveHyperphagia

Study Officials

  • Ruth Striegel, PhD

    Wesleyan University

    PRINCIPAL INVESTIGATOR

  • Francine Rosselli, PhD

    Manchester Community College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Visting Scholar, Dept of Psychology; Co-Investigator, BEST4US

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 27, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

US(2)