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

NCT00108901 | Completed Phase 2

• 3 other identifiers: 60692 (completed)R01DK060692R01DK070922
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Insulin area under the curve (oral glucose tolerance test)

  10-15 weeks

• Body composition (% body fat, visceral fat)

  10-15 weeks

• Aerobic fitness

  10-15 weeks

• Cognition (Executive function)

  10-15 weeks

Secondary Outcomes (5)

• Glucose (oral glucose tolerance test)

  10-15 weeks

• Lipid profile

  10-15 weeks

• Inflammation (C-reactive protein, fibrinogen)

  10-15 weeks

• Blood pressure

  10-15 weeks

• Academic achievement

  10-15 weeks

Study Arms (3)

Control

NO INTERVENTION

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.

Low Dose

EXPERIMENTAL

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

High dose

EXPERIMENTAL

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

Interventions

Aerobic exercise program BEHAVIORAL

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).

High dose; Low Dose

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Overweight, sedentary children
• Black or white race
• Attending specific schools in Augusta, GA area from which this study is recruiting

You may not qualify if:

• Unable to participate in testing or vigorous exercise program
• Diabetes
• Taking medication that would affect study results
• Sibling enrolled in project

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Georgia Prevention Institute, Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Related Publications (4)

• 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.

  PMID: 17135615 RESULT

• 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.

  PMID: 18274222 RESULT

• 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.

  PMID: 19777141 RESULT

• 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.

  PMID: 22990269 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Overweight; Metabolic Syndrome; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavior

Study Officials

• Catherine L Davis, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 20, 2005
• First Posted: April 21, 2005
• Study Start: June 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

US (1)