This trial is active, not recruiting.

Conditions obesity, low fitness
Treatment exercise
Sponsor University of Wisconsin, Madison
Start date March 2002
End date December 2011
Trial size 360 participants
Trial identifier NCT00205296, 2002-090


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

maximal VO2 levels
time frame: 9 months

Secondary Outcomes

fasting insulin and glucose levels
time frame: 9 months

Eligibility Criteria

Male or female participants from 7 years up to 16 years old.

Inclusion Criteria: - obesity - low fitness Exclusion Criteria: - diagnosis of diabetes - inability to exercise

Additional Information

Official title Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children
Principal investigator Aaron Carrel, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.