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
  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
Behavioral: Healthy lifestyle class
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:


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
Arms Assigned Interventions
No Intervention: Control
Children were not provided with an after-school exercise intervention. They were free to do their usual activities.
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.
Experimental: Low Dose
This group was assigned to receive a 20 min/day dose of aerobic activity offered 5 days/week after school.
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.
Experimental: High dose
This group was assigned to receive a 40 min/day dose of aerobic activity offered 5 days/week after school.
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.

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
Investigators
Principal Investigator: Catherine L Davis, PhD Georgia Regents University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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), R01 DK060692, R01 DK070922
Study First Received: April 20, 2005
Last Updated: January 14, 2010
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014