Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
2 other identifiers
interventional
191
1 country
1
Brief Summary
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Nov 2008
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
February 1, 2016
CompletedApril 3, 2020
April 1, 2020
5 years
January 26, 2009
October 27, 2015
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Reached Binge Eating Remission
Binge Remission (abstinence from binge eating)
12 months follow-up
Secondary Outcomes (1)
BMI
12 months follow-up post-treatment
Study Arms (2)
1
ACTIVE COMPARATORStandard Care
2
EXPERIMENTALStepped-care
Interventions
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Eligibility Criteria
You may qualify if:
- Obese (BMI\>=30)
You may not qualify if:
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Related Publications (1)
Grilo CM, White MA, Ivezaj V, Gueorguieva R. Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up. Obesity (Silver Spring). 2020 Nov;28(11):2116-2124. doi: 10.1002/oby.22975. Epub 2020 Sep 27.
PMID: 32985114DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carlos Grilo
- Organization
- Yale School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Grilo, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
November 1, 2008
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
April 3, 2020
Results First Posted
February 1, 2016
Record last verified: 2020-04