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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00516919
Enrollment
79
Registered
2007-08-16
Start date
2007-08-31
Completion date
2010-12-31
Last updated
2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating, Obesity

Keywords

Obesity, Binge Eating, Monolingual Hispanic Persons, Orlistat, Behavioral Weight Loss Treatment

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.

Interventions

DRUGXenical + behavioral intervention

120 mg TID; Behavioral weight loss in Spanish

BEHAVIORALBehavioral intervention + placebo

Behavioral weight loss treatment in Spanish Placebo TID

Sponsors

Yale University
Lead SponsorOTHER
Donaghue Medical Research Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnancy * Current cardiac disease * Serious neurologic illnesses

Design outcomes

Primary

MeasureTime frameDescription
Participant BMI4 months and 6 month follow-upBody Mass Index (BMI)

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
Total Enrollment79
Total79

Baseline characteristics

CharacteristicTotal Enrollment
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
79 Participants
Age, Continuous46.3 years
STANDARD_DEVIATION 9.7
Region of Enrollment
United States
79 participants
Sex: Female, Male
Female
65 Participants
Sex: Female, Male
Male
14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 400 / 39
serious
Total, serious adverse events
0 / 400 / 39

Outcome results

Primary

Participant BMI

Body Mass Index (BMI)

Time frame: 4 months and 6 month follow-up

Population: Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.

ArmMeasureGroupValue (MEAN)Dispersion
Drug: Xenical + Behavioral: Behavioral InterventionParticipant BMIPost-treatment (4 months)36.0 kg/m^2Standard Deviation 5.9
Drug: Xenical + Behavioral: Behavioral InterventionParticipant BMI6 month follow up36.3 kg/m^2Standard Deviation 4.9
Drug: Placebo + Behavioral: Behavioral InterventionParticipant BMIPost-treatment (4 months)36.4 kg/m^2Standard Deviation 4.7
Drug: Placebo + Behavioral: Behavioral InterventionParticipant BMI6 month follow up36.8 kg/m^2Standard Deviation 4.7
Comparison: Test for group differences in BMI at post-treatment, controlling for baseline BMI.p-value: =0.51ANCOVA
Comparison: Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.p-value: =0.41ANCOVA

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026