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Completed

NCT Number: NCT00471172

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

Primary outcomes

  1. Percentage change in body weight at 6 months.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
May 9, 2007
Registry last updated
Sep 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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