Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
Comparing Orlistat/Alli to Orlistat/Alli Plus Guided Self-help Group Therapy in Overweight Binge Eaters
1 other identifier
interventional
17
1 country
1
Brief Summary
This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
September 9, 2013
CompletedSeptember 9, 2013
June 1, 2013
1.2 years
January 4, 2008
June 18, 2013
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight Loss
Change in weight in lbs from per to post treatment
3 months: Measured from pre to post treatment
Secondary Outcomes (1)
Binge Frequency
3 months: Measured from pre to post treatment
Other Outcomes (1)
Weeks of Adherence to Orlistat
Number of adherent weeks over 1 year study
Study Arms (2)
Emotion Regulation Group therapy + alli
EXPERIMENTALGroup taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
Orlistat/alli program meds only
ACTIVE COMPARATORGroup taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Interventions
Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy.
The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with online access.
Eligibility Criteria
You may qualify if:
- Body mass index greater than 27
- Binge eating at least two times per week during the 6 months prior to study entry
You may not qualify if:
- Current psychosis
- Current suicidal ideations
- Pregnant
- Receiving concurrent psychotherapy
- Unstable on psychotropic medications for 3 months prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Debra L Safer
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Debra L. Safer, MD
Stanford University Department of Psychiatry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 28, 2008
Study Start
September 1, 2007
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
September 9, 2013
Results First Posted
September 9, 2013
Record last verified: 2013-06