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The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
This study has been completed.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00108901
First received: April 20, 2005
Last updated: December 22, 2014
Last verified: December 2014
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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.
An ancillary study examined effects on cognition and achievement.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity Type 2 Diabetes Prevention Executive Function (Cognition) | Behavioral: Aerobic exercise program | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Exercise Dose and Insulin Sensitivity in Obese Children |
Resource links provided by NLM:
MedlinePlus related topics:
Exercise and Physical Fitness
Drug Information available for:
Insulin
U.S. FDA Resources
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 222 |
| Study Start Date: | June 2003 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
|
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.
|
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.
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 7 Years to 11 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00108901
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108901
Locations
| United States, Georgia | |
| Georgia Prevention Institute, Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Catherine L Davis, PhD | Augusta University |
More Information
Publications:
Tomporowski, P., Davis, C.L., Miller, P.H., Naglieri, J. (2007). Exercise and children's intelligence, cognition, and academic achievement. In press, Educational Psychology Review; Online First, Sept. 27.
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 History of Changes |
| Other Study ID Numbers: |
60692 (completed) R01DK060692 ( U.S. NIH Grant/Contract ) R01DK070922 ( U.S. NIH Grant/Contract ) |
| Study First Received: | April 20, 2005 |
| Last Updated: | December 22, 2014 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
prevention children diabetes overweight obesity metabolic syndrome exercise |
insulin resistance female male black, African-American white, Caucasian cognition executive function |
Additional relevant MeSH terms:
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 18, 2017