Fitness Training in Children

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 12, 2005
Last updated: October 1, 2015
Last verified: October 2008

We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week.

Condition Intervention
Low Fitness
Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • maximal VO2 levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting insulin and glucose levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: March 2002
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise
    this will test the effect of exercise on insulin sensitivity, fitness and body composition

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • obesity
  • low fitness

Exclusion Criteria:

  • diagnosis of diabetes
  • inability to exercise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00205296

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Aaron Carrel, MD, MPH University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00205296     History of Changes
Other Study ID Numbers: 2002-090
Study First Received: September 12, 2005
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 07, 2015