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Clinical Trial: The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
This study is currently recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Obesity | Behavior: Aerobic exercise program | Phase II |
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: Exercise Dose and Insulin Sensitivity in Obese Children
Secondary Outcomes: Glucose (oral glucose tolerance test); Lipid profile; Inflammation (C-reactive protein, fibrinogen); Blood pressure
Expected Total Enrollment: 240
Study start: June 2003; Expected completion: April 2008
Last follow-up: January 2007; Data entry closure: April 2007
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.
Eligibility
Ages Eligible for Study: 7 Years - 11 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Overweight, sedentary children
- Black or white race
- Attending specific schools in Augusta, GA area from which this study is recruiting
Exclusion Criteria:
- Unable to participate in testing or vigorous exercise program
- Diabetes
- Taking medication that would affect study results
- Sibling enrolled in project
Location and Contact Information
Georgia
Georgia Prevention Institute, Medical College of Georgia, Augusta, Georgia, 30912, United States; Recruiting
Catherine L Davis, PhD, Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 21, 2005
Record first received: April 20, 2005
ClinicalTrials.gov Identifier: NCT00108901
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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