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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Aerobic exercise program | Vigorous 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.