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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00471172
First received: May 7, 2007
Last updated: September 12, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Obesity
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage change in body weight at 6 months.

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

Estimated Enrollment: 350
Study Start Date: August 2004
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471172

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Kissimmee, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States
United States, Pennsylvania
Pfizer Investigational Site
Harleysville, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Warwick, Rhode Island, United States
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00471172     History of Changes
Other Study ID Numbers: A9001187
Study First Received: May 7, 2007
Last Updated: September 12, 2008
Health Authority: Unknown:

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014