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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00471172
First received: May 7, 2007
Last updated: September 12, 2008
Last verified: September 2008

May 7, 2007
September 12, 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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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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
Both
25 Years to 60 Years
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