Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
1 other identifier
interventional
79
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 obesity
Started Aug 2007
Typical duration for phase_4 obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 15, 2007
CompletedFirst Posted
Study publicly available on registry
August 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
February 7, 2013
CompletedApril 2, 2020
March 1, 2020
3.3 years
August 15, 2007
July 31, 2012
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant BMI
Body Mass Index (BMI)
4 months and 6 month follow-up
Study Arms (2)
1
EXPERIMENTALXenical + behavioral intervention
2
ACTIVE COMPARATORPlacebo + behavioral intervention
Interventions
120 mg TID; Behavioral weight loss in Spanish
Eligibility Criteria
You may qualify if:
- Monolingual Spanish Speaking
- Obese (BMI \>= 30)
You may not qualify if:
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Donaghue Medical Research Foundationcollaborator
Study Sites (2)
Hispanic Clinic of the Connecticut Mental Health Center
New Haven, Connecticut, 06511, United States
Yale Department of Psychiatry
New Haven, Connecticut, 06519, United States
Related Publications (2)
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.
PMID: 34582624DERIVEDGrilo 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.
PMID: 23376451DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carlos Grilo
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos M Grilo, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2007
First Posted
August 16, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 2, 2020
Results First Posted
February 7, 2013
Record last verified: 2020-03