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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Executive Function (Cognition); Type 2 Diabetes Prevention; Obesity

Treatments: Behavioral: Aerobic exercise program

Study type: Interventional

Funder types: NIH

Identifiers

NCT00108901

R01DK060692 (U.S. NIH Grant/Contract)

R01DK070922 (U.S. NIH Grant/Contract)

60692 (completed)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 3 patient groups

Control

No Intervention group

Description:

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.

Low Dose

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic exercise program

High dose

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic exercise program