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OpenTrials
Completed

NCT Number: NCT02227095

Exercise & Overweight Children's Cognition

This research focuses on overweight, sedentary children whose health, cognition, and academic performance are therefore at risk, and who may be particularly responsive to exercise interventions.

This study will determine whether regular exercise per se (i.e. compared to attention control, or placebo, condition) benefits children's cognition and achievement, and will provide insight into neural mechanisms. A substudy will examine exercise-induced changes in brain structure.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by persuading policymakers, schools and communities that time spent in physical activity enhances, rather than detracts from, learning.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

About this study

An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1, http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&icde=20104167)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 8-11 years of age
  • Overweight or obese (BMI-for-age >= 85th percentile)
  • Able to participate in exercise testing and intervention

Exclusion criteria

  • Medical condition or medications that would interfere with measurements
  • Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
  • T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption

Treatment and study plan

Exercise

Behavioral

Heart rate monitors worn by each child at each session

Other names: Aerobic training

After-school program

Behavioral

Supervised recreational program with token economy

Primary outcomes

  1. Change in Planning Scale scores

    Time frame: Baseline, 8 months, one-year follow-up

    The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function

  2. Change in functional MRI

    Time frame: Baseline, 8 months

    Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks

Secondary outcomes

  1. Change in BMI

    Time frame: Baseline, 8 months, one-year follow-up

    BMI and BMI z-score, per current norms, will be calculated

  2. Change in adiposity

    Time frame: Baseline, 8 months, one-year follow-up

    Percent fat via whole-body dual-energy x-ray absorptiometry

  3. Change in aerobic fitness

    Time frame: Baseline, 8 months, one-year follow-up

    VO2 peak via treadmill test

  4. Change in Tower of London scores

    Time frame: Baseline, 8 months, one-year follow-up

    Individually administered standardized psychological assessment of executive function

  5. Change in teacher ratings of classroom behavior

    Time frame: Baseline, 8 months

    Behavior Rating Inventory for Executive Functions-Teacher form

  6. Change in academic achievement

    Time frame: Baseline, 8 months, one-year follow-up

    Woodcock-Johnson Test of Achievement III

  7. Change in performance on executive function tasks

    Time frame: Baseline, 8 months

    Antisaccade and flanker tasks - error rates, interference effect

Other outcomes

  1. Change in physical activity outside the program

    Time frame: Baseline, 8 months, one-year follow-up

    Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months

  2. Attendance to the interventions

    Time frame: 8 months

  3. Average heart rate during the exercise intervention

    Time frame: 8 months

    Polar heart rate monitors will be worn by each child in the exercise intervention and downloaded after each session. Average heart rate during the session will be recorded daily. The mean for each child over the intervention period will be computed.

  4. Points earned during the intervention

    Time frame: 8 months

    Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • San Francisco State University
  • University of Georgia

Registry information

Acronym: SMART

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 27, 2014
Registry last updated
Mar 6, 2015

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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