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
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.
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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie lifestyle interventions in obesity management as studied in NCT00471172?
How does the efficacy of non-pharmacologic weight loss programs compare to standard-of-care pharmacotherapy for obesity?
Are there specific biomarkers that correlate with successful weight loss outcomes in lifestyle modification programs like NCT00471172?
What are the potential adverse events associated with intensive counseling in obesity treatment and how are they managed?
How do combination approaches of lifestyle modification and pharmacotherapy (e.g., sibutramine) influence long-term weight management compared to monotherapies?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States
Pfizer Investigational Site🇺🇸Milwaukee, Wisconsin, United States