Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00601354
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Debra L. Safer, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Overweight
Eating Disorders
Interventions Behavioral: Emotion regulation group therapy
Drug: Orlistat/alli program
Enrollment 17
Recruitment Details 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 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.
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Hide Arm/Group Description 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 Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Period Title: Overall Study
Started 8 9
Completed 4 4
Not Completed 4 5
Reason Not Completed
Lost to Follow-up             4             5
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone Total
Hide Arm/Group Description 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 Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
9
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
48.6  (11.2) 50.1  (4.1) 49.4  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
8
 100.0%
7
  77.8%
15
  88.2%
Male
0
   0.0%
2
  22.2%
2
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
1.Primary Outcome
Title Weight Loss
Hide Description Change in weight in lbs from per to post treatment
Time Frame 3 months: Measured from pre to post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Used intent-to-treat analysis
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Hide Arm/Group Description:
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
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: lbs
6.15  (14.36) 3.61  (8.11)
2.Secondary Outcome
Title Binge Frequency
Hide Description frequency of objective binge days over prior 28 days
Time Frame 3 months: Measured from pre to post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Hide Arm/Group Description:
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
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: % change objective binge days
9.0  (2.13) 12.11  (5.44)
3.Other Pre-specified Outcome
Title Weeks of Adherence to Orlistat
Hide Description [Not Specified]
Time Frame Number of adherent weeks over 1 year study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Hide Arm/Group Description:
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
Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: week of adherence to orlistat
13.8  (17.3) 20.6  (19.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Hide Arm/Group Description 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 Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
All-Cause Mortality
OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OTC Orlistat + Guided Self-help Affect Regulation OTC Orlistat /Medication Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Debra L Safer
Organization: Stanford University
Phone: 650-723-7928
EMail: dlsafer@stanford.edu
Layout table for additonal information
Responsible Party: Debra L. Safer, Stanford University
ClinicalTrials.gov Identifier: NCT00601354     History of Changes
Other Study ID Numbers: K23MH066330 ( U.S. NIH Grant/Contract )
K23MH066330 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2008
First Posted: January 28, 2008
Results First Submitted: June 18, 2013
Results First Posted: September 9, 2013
Last Update Posted: September 9, 2013