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Trial record 32 of 69 for:    ORLISTAT

Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

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ClinicalTrials.gov Identifier: NCT00516919
Recruitment Status : Completed
First Posted : August 16, 2007
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Carlos Grilo, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Obesity
Binge Eating
Interventions Drug: Xenical + behavioral intervention
Behavioral: Behavioral intervention + placebo
Enrollment 79
Recruitment Details The study enrolled participants from August 2007 through October 2009. Participants were a consecutive series of 79 monolingual (Spanish-speaking-only) obese Latino/as recruited from clinical teams and referrals at a community mental health center serving economically disadvantaged persons with mental health needs.
Pre-assignment Details  
Arm/Group Title Xenical + Behavioral Intervention Placebo + Behavioral Intervention
Hide Arm/Group Description

Drug: Xenical + Behavioral: behavioral intervention

Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish

Drug: Placebo + Behavioral: behavioral intervention

Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day

Period Title: Overall Study
Started 40 39
Completed 30 32
Not Completed 10 7
Arm/Group Title Total Enrollment
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
<=18 years
0
   0.0%
Between 18 and 65 years
79
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants
46.3  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
65
  82.3%
Male
14
  17.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 79 participants
79
1.Primary Outcome
Title Participant BMI
Hide Description Body Mass Index (BMI)
Time Frame 4 months and 6 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.
Arm/Group Title Drug: Xenical + Behavioral: Behavioral Intervention Drug: Placebo + Behavioral: Behavioral Intervention
Hide Arm/Group Description:

Xenical + behavioral intervention

Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish

Placebo + behavioral intervention

Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID

Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Post-treatment (4 months) 36.0  (5.9) 36.4  (4.7)
6 month follow up 36.3  (4.9) 36.8  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug: Xenical + Behavioral: Behavioral Intervention, Drug: Placebo + Behavioral: Behavioral Intervention
Comments Test for group differences in BMI at post-treatment, controlling for baseline BMI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.51
Comments [Not Specified]
Method ANCOVA
Comments Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)
Method of Estimation Estimation Parameter F statistic
Estimated Value 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Drug: Xenical + Behavioral: Behavioral Intervention, Drug: Placebo + Behavioral: Behavioral Intervention
Comments Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.41
Comments [Not Specified]
Method ANCOVA
Comments Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)
Method of Estimation Estimation Parameter F statistic
Estimated Value 0.69
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected for the duration of the trial (through 4 months of active treatment).
Adverse Event Reporting Description Overall frequency of reported side effects was only slightly higher for Xenical than for placebo, although reports of minor gastrointestinal events known to be due to Xenical’s mechanism of action were higher for the Xenical condition. Nearly all events occurred early in treatment, were generally mild, and resolved spontaneously.
 
Arm/Group Title Drug: Xenical + Behavioral: Behavioral Intervention Drug: Placebo + Behaviora: Behavioral Intervention
Hide Arm/Group Description

Xenical + behavioral intervention

Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish

Placebo + behavioral intervention

Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID

All-Cause Mortality
Drug: Xenical + Behavioral: Behavioral Intervention Drug: Placebo + Behaviora: Behavioral Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Drug: Xenical + Behavioral: Behavioral Intervention Drug: Placebo + Behaviora: Behavioral Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug: Xenical + Behavioral: Behavioral Intervention Drug: Placebo + Behaviora: Behavioral Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (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. Carlos Grilo
Organization: Yale University School of Medicine
Phone: 203-785-2792
EMail: carlos.grilo@yale.edu
Layout table for additonal information
Responsible Party: Carlos Grilo, Yale University
ClinicalTrials.gov Identifier: NCT00516919     History of Changes
Other Study ID Numbers: DF-06-018
First Submitted: August 15, 2007
First Posted: August 16, 2007
Results First Submitted: July 31, 2012
Results First Posted: February 7, 2013
Last Update Posted: February 7, 2013