Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00471172

Run by

Pfizer

People needed

350

Starts

2004-08-01

Expected to finish

2005-05-01

Last updated by the study team

2008-09-15

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Kissimmee, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Milford, Massachusetts, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Harleysville, Pennsylvania, United States
• Pfizer Investigational Site — Warwick, Rhode Island, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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