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

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: NCT00516919
Recruitment Status : Completed
First Posted : August 16, 2007
Results First Posted : February 7, 2013
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.

Condition or disease Intervention/treatment Phase
Obesity Binge Eating Drug: Xenical + behavioral intervention Behavioral: Behavioral intervention + placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Study Start Date : August 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Xenical + behavioral intervention
 Drug: Xenical + behavioral intervention
120 mg TID; Behavioral weight loss in Spanish
Other Name: Xenical
Active Comparator: 2
Placebo + behavioral intervention
 Behavioral: Behavioral intervention + placebo
Behavioral weight loss treatment in Spanish Placebo TID


Outcome Measures
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Primary Outcome Measures :
  1. Participant BMI [ Time Frame: 4 months and 6 month follow-up ]
    Body Mass Index (BMI)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Monolingual Spanish Speaking
  • Obese (BMI >= 30)

Exclusion Criteria:

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516919


Locations
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United States, Connecticut
Hispanic Clinic of the Connecticut Mental Health Center
New Haven, Connecticut, United States, 06511
Yale Department of Psychiatry
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Donaghue Medical Research Foundation
Investigators
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Principal Investigator: Carlos M Grilo, PhD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00516919    
Other Study ID Numbers: 0608001753
First Posted: August 16, 2007    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Yale University:
Obesity
Binge Eating
Monolingual Hispanic Persons
Orlistat
Behavioral Weight Loss Treatment
Additional relevant MeSH terms:
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Obesity
Weight Loss
Bulimia
Binge-Eating Disorder
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes
 Feeding and Eating Disorders
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents