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

Phase 2

Completed

• Conditions: Obesity; Type 2 Diabetes Prevention; Executive Function (Cognition)
• Interventions: Behavioral: Aerobic exercise program

• Registration Number: NCT00108901
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-04-20
• Study First Submitted QC: 2005-04-20
• Study First Posted: 2005-04-21
• Primary Completion: 2006-12
• Study Completion: 2007-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Aerobic exercise program	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.
Low Dose	Aerobic exercise program	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Inflammation (C-reactive protein, fibrinogen)	10-15 weeks
Glucose (oral glucose tolerance test)	10-15 weeks
Lipid profile	10-15 weeks
Blood pressure	10-15 weeks
Academic achievement	10-15 weeks

Trial Locations

Locations (1)

Georgia Prevention Institute, Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States