Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
1 other identifier
interventional
350
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2004
Shorter than P25 for not_applicable obesity
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedSeptember 15, 2008
September 1, 2008
May 7, 2007
September 12, 2008
Conditions
Outcome Measures
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.
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and \<40 kg/m2.
- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- Willingness and ability to comply with study related procedures
- Access to Internet and email
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Kissimmee, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
August 1, 2004
Study Completion
May 1, 2005
Last Updated
September 15, 2008
Record last verified: 2008-09