Trial Outcomes & Findings for Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons (NCT NCT00516919)

NCT ID: NCT00516919

Last Updated: 2020-04-02

Results Overview

Body Mass Index (BMI)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 79 participants
• Primary outcome timeframe: 4 months and 6 month follow-up
• Results posted on: 2020-04-02

Participant Flow

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.

Participant milestones

Measure	Xenical + Behavioral Intervention Drug: Xenical + Behavioral: behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish	Placebo + Behavioral Intervention Drug: Placebo + Behavioral: behavioral intervention Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day
Overall Study STARTED	40	39
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Enrollment n=79 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	79 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Body Mass Index (BMI)

Outcome measures

Measure	Drug: Xenical + Behavioral: Behavioral Intervention n=40 Participants Xenical + behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish	Drug: Placebo + Behavioral: Behavioral Intervention n=39 Participants Placebo + behavioral intervention Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID
Participant BMI Post-treatment (4 months)	36.0 kg/m^2 Standard Deviation 5.9	36.4 kg/m^2 Standard Deviation 4.7
Participant BMI 6 month follow up	36.3 kg/m^2 Standard Deviation 4.9	36.8 kg/m^2 Standard Deviation 4.7

Adverse Events

Drug: Xenical + Behavioral: Behavioral Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug: Placebo + Behaviora: Behavioral Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos Grilo

Yale University School of Medicine

Phone: 203-785-2792

Email: carlos.grilo@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place