A Phase 2 interventional study of Aerobic exercise program in Obesity, Type 2 Diabetes Prevention and Executive Function (Cognition), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-24.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Prevention
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.
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.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 222 is above the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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
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).
Insulin area under the curve (oral glucose tolerance test)
Time frame: 10-15 weeks
Body composition (% body fat, visceral fat)
Time frame: 10-15 weeks
Aerobic fitness
Time frame: 10-15 weeks
Cognition (Executive function)
Time frame: 10-15 weeks
Glucose (oral glucose tolerance test)
Time frame: 10-15 weeks
Lipid profile
Time frame: 10-15 weeks
Inflammation (C-reactive protein, fibrinogen)
Time frame: 10-15 weeks
Blood pressure
Time frame: 10-15 weeks
Academic achievement
Time frame: 10-15 weeks
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)