Clinical Trials Directory

Trials / Completed

CompletedNCT00108901

The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children

Exercise Dose and Insulin Sensitivity in Obese Children

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
222 (actual)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
7 Years – 11 Years
Healthy volunteers
Accepted

Summary

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren. The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases. An ancillary study examined effects on cognition and achievement.

Detailed description

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren. Blinded psychological assessments of cognition and achievement were obtained.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAerobic exercise programVigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of \>150 bpm average HR each day and attending at least 80% of sessions (4 days/week).

Timeline

Start date
2003-06-01
Primary completion
2006-12-01
Completion
2007-01-01
First posted
2005-04-21
Last updated
2014-12-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00108901. Inclusion in this directory is not an endorsement.