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

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Behavioral: Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)
• Behavioral: Face-to-face counseling by a dietitian (monthly)
• Behavioral: Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)
• Behavioral: Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)
• Behavioral: Self help

Primary Measures

• Percentage change in body weight at 6 months.

Secondary Measures

• Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471172

Study ID Number: A9001187

ClinicalTrials.gov Identifier: NCT00471172

Health Authority: Unknown:

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