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Trial record 1 of 1 for:    NCT00471172
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Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss

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ClinicalTrials.gov Identifier: NCT00471172
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : September 15, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 7, 2007
First Posted Date  ICMJE May 9, 2007
Last Update Posted Date September 15, 2008
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
Percentage change in body weight at 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00471172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
Official Title  ICMJE A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 7, 2007)
350
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471172
Other Study ID Numbers  ICMJE A9001187
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2008

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