Clinical trial NCT00108901: The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
Official title: Exercise Dose and Insulin Sensitivity in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Type 2 Diabetes Prevention
Executive Function (Cognition)
Keywords: prevention
children
diabetes
overweight
obesity
metabolic syndrome
exercise
insulin resistance
female
male
black, African-American
white, Caucasian
cognition
executive function
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-04-21
Enrollment: 222
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Insulin area under the curve (oral glucose tolerance test)
timeFrame: 10-15 weeks
measure: Body composition (% body fat, visceral fat)
timeFrame: 10-15 weeks
measure: Aerobic fitness
timeFrame: 10-15 weeks
measure: Cognition (Executive function)
timeFrame: 10-15 weeks
Secondary outcomes:
measure: Glucose (oral glucose tolerance test)
timeFrame: 10-15 weeks
measure: Lipid profile
timeFrame: 10-15 weeks
measure: Inflammation (C-reactive protein, fibrinogen)
timeFrame: 10-15 weeks
measure: Blood pressure
timeFrame: 10-15 weeks
measure: Academic achievement
timeFrame: 10-15 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute, Medical College of Georgia
state: Georgia
Study officials:
affiliation: Augusta University
name: Catherine L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis CL, Tkacz J, Gregoski M, Boyle CA, Lovrekovic G. Aerobic exercise and snoring in overweight children: a randomized controlled trial. Obesity (Silver Spring). 2006 Nov;14(11):1985-91. doi: 10.1038/oby.2006.232.
citation: Davis CL, Tomporowski PD, Boyle CA, Waller JL, Miller PH, Naglieri JA, Gregoski M. Effects of aerobic exercise on overweight children's cognitive functioning: a randomized controlled trial. Res Q Exerc Sport. 2007 Dec;78(5):510-9. doi: 10.1080/02701367.2007.10599450.
citation: Tomporowski PD, Davis CL, Miller PH, Naglieri JA. Exercise and Children's Intelligence, Cognition, and Academic Achievement. Educ Psychol Rev. 2008 Jun 1;20(2):111-131. doi: 10.1007/s10648-007-9057-0.
citation: Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Melendez A, Boyle CA, Gower BA. Exercise dose and diabetes risk in overweight and obese children: a randomized controlled trial. JAMA. 2012 Sep 19;308(11):1103-12. doi: 10.1001/2012.jama.10762.