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

Pfizer

Status: Completed

Conditions: Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00471172

A9001187

Details and patient eligibility

About

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.

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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.