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

Primary Purpose

Obesity, Binge Eating

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Xenical + behavioral intervention
Behavioral intervention + placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Binge Eating, Monolingual Hispanic Persons, Orlistat, Behavioral Weight Loss Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Current cardiac disease
  • Serious neurologic illnesses

Sites / Locations

  • Hispanic Clinic of the Connecticut Mental Health Center
  • Yale Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Xenical + behavioral intervention

Placebo + behavioral intervention

Outcomes

Primary Outcome Measures

Participant BMI
Body Mass Index (BMI)

Secondary Outcome Measures

Full Information

First Posted
August 15, 2007
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
Donaghue Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00516919
Brief Title
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Official Title
Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Donaghue Medical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Binge Eating
Keywords
Obesity, Binge Eating, Monolingual Hispanic Persons, Orlistat, Behavioral Weight Loss Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Xenical + behavioral intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Placebo + behavioral intervention
Intervention Type
Drug
Intervention Name(s)
Xenical + behavioral intervention
Other Intervention Name(s)
Xenical
Intervention Description
120 mg TID; Behavioral weight loss in Spanish
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention + placebo
Intervention Description
Behavioral weight loss treatment in Spanish Placebo TID
Primary Outcome Measure Information:
Title
Participant BMI
Description
Body Mass Index (BMI)
Time Frame
4 months and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Monolingual Spanish Speaking Obese (BMI >= 30) Exclusion Criteria: Pregnancy Current cardiac disease Serious neurologic illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos M Grilo, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hispanic Clinic of the Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale Department of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34582624
Citation
Grilo CM, Kerrigan SG, Lydecker JA, White MA. Physical activity changes during behavioral weight loss treatment by Latinx patients with obesity with and without binge eating disorder. Obesity (Silver Spring). 2021 Dec;29(12):2026-2034. doi: 10.1002/oby.23278. Epub 2021 Sep 28.
Results Reference
derived
PubMed Identifier
23376451
Citation
Grilo CM, White MA. Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as. Behav Res Ther. 2013 Mar;51(3):167-75. doi: 10.1016/j.brat.2013.01.002. Epub 2013 Jan 18.
Results Reference
derived

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

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