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

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ClinicalTrials.gov Identifier: NCT00108901
Recruitment Status : Completed
First Posted : April 21, 2005
Last Update Posted : December 24, 2014
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Prevention Executive Function (Cognition) Behavioral: Aerobic exercise program Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise Dose and Insulin Sensitivity in Obese Children
Study Start Date : June 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Low Dose
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
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).
Experimental: High dose
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).


Outcome Measures
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Primary Outcome Measures :
  1. Insulin area under the curve (oral glucose tolerance test) [ Time Frame: 10-15 weeks ]
  2. Body composition (% body fat, visceral fat) [ Time Frame: 10-15 weeks ]
  3. Aerobic fitness [ Time Frame: 10-15 weeks ]
  4. Cognition (Executive function) [ Time Frame: 10-15 weeks ]

Secondary Outcome Measures :
  1. Glucose (oral glucose tolerance test) [ Time Frame: 10-15 weeks ]
  2. Lipid profile [ Time Frame: 10-15 weeks ]
  3. Inflammation (C-reactive protein, fibrinogen) [ Time Frame: 10-15 weeks ]
  4. Blood pressure [ Time Frame: 10-15 weeks ]
  5. Academic achievement [ Time Frame: 10-15 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108901


Locations
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United States, Georgia
Georgia Prevention Institute, Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Catherine L Davis, PhD Augusta University
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Catherine L. Davis PhD, Principal Investigator, Assoc. Prof. of Pediatrics, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00108901    
Other Study ID Numbers: 60692 (completed)
R01DK060692 ( U.S. NIH Grant/Contract )
R01DK070922 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2005    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
prevention
children
diabetes
overweight
obesity
metabolic syndrome
exercise
 insulin resistance
female
male
black, African-American
white, Caucasian
cognition
executive function
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases