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NCT Number: NCT00108901

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Executive Function (Cognition) Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Prevention

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Georgia Prevention Institute, Medical College of Georgia

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Exercise Dose and Insulin Sensitivity in Obese Children

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Apr 21, 2005
Registry last updated
Dec 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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