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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	350 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2004
Actual Study Completion Date :	May 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Percentage change in body weight at 6 months.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

To obtain contact information for a study center near you, click here. 

ClinicalTrials.gov Identifier:	NCT00471172 History of Changes
Other Study ID Numbers:	A9001187
First Posted:	May 9, 2007
Last Update Posted:	September 15, 2008
Last Verified:	September 2008

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms