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Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss

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ClinicalTrials.gov Identifier: NCT00664547
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : April 23, 2008
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Queen's University

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date April 23, 2008
Study Start Date  ICMJE September 1997
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April¬†22,¬†2008)
  • Abdominal obesity [ Time Frame: 3 months ]
  • Insulin Resistance [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Official Title  ICMJE Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Brief Summary The purpose of the trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. We hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Diet Weight Loss
  • Behavioral: Exercise Weight Loss
  • Behavioral: Exercise Without Weight Loss
Study Arms  ICMJE
  • No Intervention: C
  • Active Comparator: DWL
    Diet Weight Loss
    Intervention: Behavioral: Diet Weight Loss
  • Active Comparator: EWL
    Exercise Weight Loss
    Intervention: Behavioral: Exercise Weight Loss
  • Active Comparator: EWS
    Exercise without weight loss
    Intervention: Behavioral: Exercise Without Weight Loss
Publications * Ross R, Dagnone D, Jones PJ, Smith H, Paddags A, Hudson R, Janssen I. Reduction in obesity and related comorbid conditions after diet-induced weight loss or exercise-induced weight loss in men. A randomized, controlled trial. Ann Intern Med. 2000 Jul 18;133(2):92-103.

*   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 Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 1999
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men between 20 and 60 yrs

Exclusion Criteria:

  • Smokers and diabetics
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664547
Other Study ID Numbers  ICMJE Ross 1997
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Robert Ross, PhD Queen's University
PRS Account Queen's University
Verification Date April 2008

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