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

September 12, 2008 updated by: Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage change in body weight at 6 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 9, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2008

Last Update Submitted That Met QC Criteria

September 12, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9001187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe