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

NCT ID: NCT00516919

Last Updated: 2020-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Binge Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Xenical + behavioral intervention

Group Type EXPERIMENTAL

Xenical + behavioral intervention

Intervention Type DRUG

120 mg TID; Behavioral weight loss in Spanish

2

Placebo + behavioral intervention

Group Type ACTIVE_COMPARATOR

Behavioral intervention + placebo

Intervention Type BEHAVIORAL

Behavioral weight loss treatment in Spanish Placebo TID

Interventions

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Xenical + behavioral intervention

120 mg TID; Behavioral weight loss in Spanish

Intervention Type DRUG

Behavioral intervention + placebo

Behavioral weight loss treatment in Spanish Placebo TID

Intervention Type BEHAVIORAL

Other Intervention Names

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Xenical

Eligibility Criteria

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Inclusion Criteria

* Monolingual Spanish Speaking
* Obese (BMI \>= 30)

Exclusion Criteria

* Pregnancy
* Current cardiac disease
* Serious neurologic illnesses
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Donaghue Medical Research Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos M Grilo, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Hispanic Clinic of the Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Yale Department of Psychiatry

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34582624 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23376451 (View on PubMed)

Other Identifiers

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0608001753

Identifier Type: -

Identifier Source: org_study_id

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