Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debra L. Safer, Stanford University
ClinicalTrials.gov Identifier:
NCT00601354
First received: January 4, 2008
Last updated: June 26, 2013
Last verified: June 2013
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Overweight
Eating Disorders
Interventions: Behavioral: Emotion regulation group therapy
Drug: Orlistat/alli program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through newspaper advertisements and flyers. The study took place at an outpatient psychiatry department of a large university medical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no wash out, run-in, or transition following participant enrollment.Exclusion criteria are described previously. Main exclusion was weight less than 27 kg/m2.

Reporting Groups
  Description
OTC Orlistat + Guided Self-help Affect Regulation Group 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
OTC Orlistat /Medication Management Alone Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone

Participant Flow:   Overall Study
    OTC Orlistat + Guided Self-help Affect Regulation     OTC Orlistat /Medication Management Alone  
STARTED     8     9  
COMPLETED     4     4  
NOT COMPLETED     4     5  
Lost to Follow-up                 4                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
OTC Orlistat + Guided Self-help Affect Regulation Group 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
OTC Orlistat /Medication Management Alone Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Total Total of all reporting groups

Baseline Measures
    OTC Orlistat + Guided Self-help Affect Regulation     OTC Orlistat /Medication Management Alone     Total  
Number of Participants  
[units: participants]
  8     9     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     9     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.6  ± 11.2     50.1  ± 4.1     49.4  ± 11.4  
Gender  
[units: participants]
     
Female     8     7     15  
Male     0     2     2  
Region of Enrollment  
[units: participants]
     
United States     8     9     17  



  Outcome Measures
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1.  Primary:   Weight Loss   [ Time Frame: 3 months: Measured from pre to post treatment ]

2.  Secondary:   Binge Frequency   [ Time Frame: 3 months: Measured from pre to post treatment ]

3.  Other Pre-specified:   Weeks of Adherence to Orlistat   [ Time Frame: Number of adherent weeks over 1 year study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Debra L Safer
Organization: Stanford University
phone: 650-723-7928
e-mail: dlsafer@stanford.edu


No publications provided


Responsible Party: Debra L. Safer, Stanford University
ClinicalTrials.gov Identifier: NCT00601354     History of Changes
Other Study ID Numbers: K23 MH066330, K23MH066330
Study First Received: January 4, 2008
Results First Received: June 18, 2013
Last Updated: June 26, 2013
Health Authority: United States: Federal Government