The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
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ClinicalTrials.gov Identifier: NCT00108901 |
Recruitment Status :
Completed
First Posted : April 21, 2005
Last Update Posted : December 24, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
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Obesity Type 2 Diabetes Prevention Executive Function (Cognition) | Behavioral: Aerobic exercise program | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Exercise Dose and Insulin Sensitivity in Obese Children |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
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No Intervention: Control
Children were not provided with an after-school exercise intervention. They were free to do their usual activities. Families were offered a monthly healthy lifestyle class.
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Experimental: Low Dose
This group was assigned to receive a 20 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class.
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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). |
Experimental: High dose
This group was assigned to receive a 40 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class.
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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). |
- Insulin area under the curve (oral glucose tolerance test) [ Time Frame: 10-15 weeks ]
- Body composition (% body fat, visceral fat) [ Time Frame: 10-15 weeks ]
- Aerobic fitness [ Time Frame: 10-15 weeks ]
- Cognition (Executive function) [ Time Frame: 10-15 weeks ]
- Glucose (oral glucose tolerance test) [ Time Frame: 10-15 weeks ]
- Lipid profile [ Time Frame: 10-15 weeks ]
- Inflammation (C-reactive protein, fibrinogen) [ Time Frame: 10-15 weeks ]
- Blood pressure [ Time Frame: 10-15 weeks ]
- Academic achievement [ Time Frame: 10-15 weeks ]

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Ages Eligible for Study: | 7 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108901
United States, Georgia | |
Georgia Prevention Institute, Medical College of Georgia | |
Augusta, Georgia, United States, 30912 |
Principal Investigator: | Catherine L Davis, PhD | Augusta University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Catherine L. Davis PhD, Principal Investigator, Assoc. Prof. of Pediatrics, Medical College of Georgia |
ClinicalTrials.gov Identifier: | NCT00108901 |
Other Study ID Numbers: |
60692 (completed) R01DK060692 ( U.S. NIH Grant/Contract ) R01DK070922 ( U.S. NIH Grant/Contract ) |
First Posted: | April 21, 2005 Key Record Dates |
Last Update Posted: | December 24, 2014 |
Last Verified: | December 2014 |
prevention children diabetes overweight obesity metabolic syndrome exercise |
insulin resistance female male black, African-American white, Caucasian cognition executive function |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |