Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: 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)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
Study design: Other, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Percentage change in body weight at 6 months.
Secondary outcome: Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
Eligibility
Minimum age: 25 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Los Angeles, California, United States
Pfizer Investigational Site, Pembroke Pines, Florida, United States
Pfizer Investigational Site, Kissimmee, Florida, United States
Pfizer Investigational Site, Clearwater, Florida, United States
Pfizer Investigational Site, Louisville, Kentucky, United States
Pfizer Investigational Site, Lexington, Kentucky, United States
Pfizer Investigational Site, Milford, Massachusetts, United States
Pfizer Investigational Site, Charlotte, North Carolina, United States
Pfizer Investigational Site, Harleysville, Pennsylvania, United States
Pfizer Investigational Site, Warwick, Rhode Island, United States
Pfizer Investigational Site, Nashville, Tennessee, United States
Pfizer Investigational Site, Milwaukee, Wisconsin, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2004
Ending date: May 2005
Last updated: May 7, 2007
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