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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00108901
First received: April 20, 2005
Last updated: January 14, 2010
Last verified: January 2010
History of Changes

April 20, 2005
January 14, 2010
June 2003
Not Provided
  • Insulin area under the curve (oral glucose tolerance test) [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Body composition (% body fat, visceral fat) [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Aerobic fitness [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Cognition (Executive function) [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Insulin area under the curve (oral glucose tolerance test)
  • Body composition (% body fat, visceral fat)
  • Aerobic fitness
Complete list of historical versions of study NCT00108901 on ClinicalTrials.gov Archive Site
  • Glucose (oral glucose tolerance test) [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Inflammation (C-reactive protein, fibrinogen) [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Academic achievement [ Time Frame: 10-15 weeks ] [ Designated as safety issue: No ]
  • Glucose (oral glucose tolerance test)
  • Lipid profile
  • Inflammation (C-reactive protein, fibrinogen)
  • Blood pressure
Not Provided
Not Provided
 
The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
Exercise Dose and Insulin Sensitivity in Obese Children

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Type 2 Diabetes Prevention
  • Executive Function (Cognition)
  • 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).
  • Behavioral: Healthy lifestyle class
    Families were invited to monthly seminars on health, diet, physical activity, and stress reduction. Children were taught separately with age-appropriate activities.
  • No Intervention: Control
    Children were not provided with an after-school exercise intervention. They were free to do their usual activities.
    Intervention: Behavioral: Healthy lifestyle class
  • Experimental: Low Dose
    This group was assigned to receive a 20 min/day dose of aerobic activity offered 5 days/week after school.
    Interventions:
    • Behavioral: Aerobic exercise program
    • Behavioral: Healthy lifestyle class
  • Experimental: High dose
    This group was assigned to receive a 40 min/day dose of aerobic activity offered 5 days/week after school.
    Interventions:
    • Behavioral: Aerobic exercise program
    • Behavioral: Healthy lifestyle class

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
January 2007
Not Provided

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
Both
7 Years to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108901
60692 (completed), R01 DK060692, R01 DK070922
No
Catherine L. Davis PhD, Principal Investigator, Assoc. Prof. of Pediatrics, Medical College of Georgia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Catherine L Davis, PhD Georgia Regents University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP