The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
NCT00108901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222
Last updated 2014-12-24
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.
Conditions
- Obesity
- Type 2 Diabetes Prevention
- Executive Function (Cognition)
Interventions
- 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).
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
lead NIH
Principal Investigators
-
Catherine L Davis, PhD · Augusta University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2003-06-30
- Primary Completion
- 2006-12-31
- Completion
- 2007-01-31
Countries
- United States
Study Locations
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