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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00516919
• Collaborator: Donaghue Medical Research Foundation (Other)
• Enrollment: 79
• Locations: 2
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 39.5
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Binge Eating	Drug: Xenical + behavioral intervention; Behavioral: Behavioral intervention + placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Xenical + behavioral intervention	Drug: Xenical + behavioral intervention; 120 mg TID; Behavioral weight loss in Spanish; Other Names: Xenical
Active Comparator: 2 Placebo + behavioral intervention	Behavioral: Behavioral intervention + placebo; Behavioral weight loss treatment in Spanish Placebo TID

Outcome Measures

Primary Outcome Measures

1. Participant BMI [4 months and 6 month follow-up]

   Body Mass Index (BMI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Monolingual Spanish Speaking

• Obese (BMI >= 30)

Exclusion Criteria:

• Pregnancy

• Current cardiac disease

• Serious neurologic illnesses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hispanic Clinic of the Connecticut Mental Health Center	New Haven	Connecticut	United States	06511
2	Yale Department of Psychiatry	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• Donaghue Medical Research Foundation

Investigators

• Principal Investigator: Carlos M Grilo, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00516919
• Other Study ID Numbers: 0608001753
• First Posted: Aug 16, 2007
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Yale University: Obesity; Binge Eating; Monolingual Hispanic Persons; Orlistat; Behavioral Weight Loss Treatment
• Additional relevant MeSH terms: Obesity; Weight Loss; Bulimia; Binge-Eating Disorder; Orlistat

Study Results

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.

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

Baseline Characteristics

Arm/Group Title	Total Enrollment
Arm/Group Description
Overall Participants	79
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	79 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (9.7)
Sex: Female, Male (Count of Participants)
Female	65 82.3%
Male	14 17.7%
Region of Enrollment (participants) [Number]
United States	79 100%

Outcome Measures

1. Primary Outcome

Title	Participant BMI
Description	Body Mass Index (BMI)
Time Frame	4 months and 6 month follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Drug: Xenical + Behavioral: Behavioral Intervention	Drug: Placebo + Behavioral: Behavioral Intervention
Arm/Group Description	Xenical + behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish	Placebo + behavioral intervention Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID
Measure Participants	40	39
Post-treatment (4 months)	36.0 (5.9)	36.4 (4.7)
6 month follow up	36.3 (4.9)	36.8 (4.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Drug: Xenical + Behavioral: Behavioral Intervention, Drug: Placebo + Behavioral: Behavioral Intervention
	Comments	Test for group differences in BMI at post-treatment, controlling for baseline BMI.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.51
	Comments
	Method	ANCOVA
	Comments	Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)
Method of Estimation	Estimation Parameter	F statistic
	Estimated Value	0.45
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Drug: Xenical + Behavioral: Behavioral Intervention, Drug: Placebo + Behavioral: Behavioral Intervention
	Comments	Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.41
	Comments
	Method	ANCOVA
	Comments	Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)
Method of Estimation	Estimation Parameter	F statistic
	Estimated Value	0.69
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial (through 4 months of active treatment).
Adverse Event Reporting Description	Overall frequency of reported side effects was only slightly higher for Xenical than for placebo, although reports of minor gastrointestinal events known to be due to Xenical's mechanism of action were higher for the Xenical condition. Nearly all events occurred early in treatment, were generally mild, and resolved spontaneously.
Arm/Group Title	Drug: Xenical + Behavioral: Behavioral Intervention		Drug: Placebo + Behaviora: Behavioral Intervention
Arm/Group Description	Xenical + behavioral intervention Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish		Placebo + behavioral intervention Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID
All Cause Mortality
	Drug: Xenical + Behavioral: Behavioral Intervention		Drug: Placebo + Behaviora: Behavioral Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Drug: Xenical + Behavioral: Behavioral Intervention		Drug: Placebo + Behaviora: Behavioral Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Drug: Xenical + Behavioral: Behavioral Intervention		Drug: Placebo + Behaviora: Behavioral Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.