A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity

Pfizer1 site in 1 country350 target enrollmentAugust 2004

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Pfizer
Enrollment: 350
Locations: 1
Primary Endpoint: Percentage change in body weight at 6 months.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

May 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and \<40 kg/m
•2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
•3- Willingness and ability to comply with study related procedures
•4- Access to Internet and email

Exclusion Criteria

•Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.