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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471172
First Posted: May 9, 2007
Last Update Posted: September 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
May 7, 2007
May 9, 2007
September 15, 2008
August 2004
Not Provided
Percentage change in body weight at 6 months.
Same as current
Complete list of historical versions of study NCT00471172 on ClinicalTrials.gov Archive Site
Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
Same as current
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Not Provided
 
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
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.
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2005
Not Provided

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.
Sexes Eligible for Study: All
25 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00471172
A9001187
Not Provided
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Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP