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

Primary Purpose

Obesity, Type 2 Diabetes Prevention, Executive Function (Cognition)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise program
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring prevention, children, diabetes, overweight, obesity, metabolic syndrome, exercise, insulin resistance, female, male, black, African-American, white, Caucasian, cognition, executive function

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Georgia Prevention Institute, Medical College of Georgia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Low Dose

High dose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Insulin area under the curve (oral glucose tolerance test)
Body composition (% body fat, visceral fat)
Aerobic fitness
Cognition (Executive function)

Secondary Outcome Measures

Glucose (oral glucose tolerance test)
Lipid profile
Inflammation (C-reactive protein, fibrinogen)
Blood pressure
Academic achievement

Full Information

First Posted
April 20, 2005
Last Updated
December 22, 2014
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00108901
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
High dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Insulin area under the curve (oral glucose tolerance test)
Time Frame
10-15 weeks
Title
Body composition (% body fat, visceral fat)
Time Frame
10-15 weeks
Title
Aerobic fitness
Time Frame
10-15 weeks
Title
Cognition (Executive function)
Time Frame
10-15 weeks
Secondary Outcome Measure Information:
Title
Glucose (oral glucose tolerance test)
Time Frame
10-15 weeks
Title
Lipid profile
Time Frame
10-15 weeks
Title
Inflammation (C-reactive protein, fibrinogen)
Time Frame
10-15 weeks
Title
Blood pressure
Time Frame
10-15 weeks
Title
Academic achievement
Time Frame
10-15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine L Davis, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Prevention Institute, Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17135615
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.
Results Reference
result
PubMed Identifier
18274222
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.
Results Reference
result
PubMed Identifier
19777141
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.
Results Reference
result
PubMed Identifier
22990269
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.
Results Reference
derived

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

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