Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
Not Applicable
Completed
- Conditions
- Obesity
- Registration Number
- NCT00471172
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
- 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2.
- 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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage change in body weight at 6 months.
- Secondary Outcome Measures
Name Time Method Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States