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

Exercise Dose and Insulin Sensitivity in Obese Children

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00108901
Enrollment
222
Registered
2005-04-21
Start date
2003-06-30
Completion date
2007-01-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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).

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Insulin area under the curve (oral glucose tolerance test)10-15 weeks
Body composition (% body fat, visceral fat)10-15 weeks
Aerobic fitness10-15 weeks
Cognition (Executive function)10-15 weeks

Secondary

MeasureTime frame
Glucose (oral glucose tolerance test)10-15 weeks
Academic achievement10-15 weeks
Lipid profile10-15 weeks
Inflammation (C-reactive protein, fibrinogen)10-15 weeks
Blood pressure10-15 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026