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

Purpose

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	Intervention	Phase
Obesity Type 2 Diabetes Prevention Executive Function (Cognition)	Behavioral: Aerobic exercise program	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Exercise Dose and Insulin Sensitivity in Obese Children

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Exercise and Physical Fitness

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	222
Study Start Date:	June 2003
Study Completion Date:	January 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

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.

Eligibility


Ages Eligible for Study:	7 Years to 11 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108901

Locations


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


Principal Investigator:	Catherine L Davis, PhD	Georgia Regents University

More Information

Publications:

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.

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.

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.

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

Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Meléndez 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.


Responsible Party:	Catherine L. Davis PhD, Principal Investigator, Assoc. Prof. of Pediatrics, Medical College of Georgia
ClinicalTrials.gov Identifier:	NCT00108901 History of Changes
Other Study ID Numbers:	60692 (completed), R01DK060692, R01DK070922
Study First Received:	April 20, 2005
Last Updated:	December 22, 2014
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on March 03, 2015