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

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NCT00471172

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Study Location
Pfizer Investigational Site
Los Angeles, California, , United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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