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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, United States
Contact
1-800-718-1021
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

- 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.

NCT00471172
Pfizer
Completed
Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss

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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.
Not Provided
Interventional
Not Provided
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
Not Provided
Not Provided


*   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
Not Provided
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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