The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Dose and Insulin Sensitivity in Obese Children

Conditions
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Obesity, Type 2 Diabetes Prevention, Executive Function (Cognition)

Intervention / Treatment
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* Behavioral: Aerobic exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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).<br>|
| Experimental: High dose<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin area under the curve (oral glucose tolerance test) |  | 10-15 weeks | 
| Body composition (% body fat, visceral fat) |  | 10-15 weeks | 
| Aerobic fitness |  | 10-15 weeks | 
| Cognition (Executive function) |  | 10-15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose (oral glucose tolerance test) |  | 10-15 weeks | 
| Lipid profile |  | 10-15 weeks | 
| Inflammation (C-reactive protein, fibrinogen) |  | 10-15 weeks | 
| Blood pressure |  | 10-15 weeks | 
| Academic achievement |  | 10-15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, children, diabetes, overweight, obesity, metabolic syndrome, exercise, insulin resistance, female, male, black, African-American, white, Caucasian, cognition, executive function