Exercise & Overweight Children's Cognition (SMART)

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Exercise; Behavioral: After-school program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Prevention Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After-school exercise program; 40 min/day vigorous aerobic games after school	Behavioral: Exercise; Heart rate monitors worn by each child at each session; Other Names: Aerobic training; Behavioral: After-school program; Supervised recreational program with token economy
Active Comparator: Sedentary after-school program; Attention-control condition similar to experimental condition with the exception of exercise	Behavioral: After-school program; Supervised recreational program with token economy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Planning Scale scores	The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function	Baseline, 8 months, one-year follow-up
Change in functional MRI	Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks	Baseline, 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI	BMI and BMI z-score, per current norms, will be calculated	Baseline, 8 months, one-year follow-up
Change in adiposity	Percent fat via whole-body dual-energy x-ray absorptiometry	Baseline, 8 months, one-year follow-up
Change in aerobic fitness	VO2 peak via treadmill test	Baseline, 8 months, one-year follow-up
Change in Tower of London scores	Individually administered standardized psychological assessment of executive function	Baseline, 8 months, one-year follow-up
Change in teacher ratings of classroom behavior	Behavior Rating Inventory for Executive Functions-Teacher form	Baseline, 8 months
Change in academic achievement	Woodcock-Johnson Test of Achievement III	Baseline, 8 months, one-year follow-up
Change in performance on executive function tasks	Antisaccade and flanker tasks - error rates, interference effect	Baseline, 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity outside the program	Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months	Baseline, 8 months, one-year follow-up
Attendance to the interventions		8 months
Average heart rate during the exercise intervention	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.	8 months
Points earned during the intervention	Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.	8 months

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Georgia; San Francisco State University
• Investigators: Principal Investigator: Catherine L Davis, PhD, Medical College of Georgia, Georgia Regents University; Principal Investigator: Jennifer E McDowell, PhD, University of Georgia

Publications and helpful links

General Publications

• Krafft CE, Schwarz NF, Chi L, Weinberger AL, Schaeffer DJ, Pierce JE, Rodrigue AL, Yanasak NE, Miller PH, Tomporowski PD, Davis CL, McDowell JE. An 8-month randomized controlled exercise trial alters brain activation during cognitive tasks in overweight children. Obesity (Silver Spring). 2014 Jan;22(1):232-42. doi: 10.1002/oby.20518. Epub 2013 Sep 10.
• Krafft CE, Pierce JE, Schwarz NF, Chi L, Weinberger AL, Schaeffer DJ, Rodrigue AL, Camchong J, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children. Neuroscience. 2014 Jan 3;256:445-55. doi: 10.1016/j.neuroscience.2013.09.052. Epub 2013 Oct 3.
• Krafft CE, Schaeffer DJ, Schwarz NF, Chi L, Weinberger AL, Pierce JE, Rodrigue AL, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. Improved frontoparietal white matter integrity in overweight children is associated with attendance at an after-school exercise program. Dev Neurosci. 2014;36(1):1-9. doi: 10.1159/000356219. Epub 2014 Jan 21.
• Schaeffer DJ, Krafft CE, Schwarz NF, Chi L, Rodrigue AL, Pierce JE, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. An 8-month exercise intervention alters frontotemporal white matter integrity in overweight children. Psychophysiology. 2014 Aug;51(8):728-33. doi: 10.1111/psyp.12227. Epub 2014 May 5.
• Schaeffer DJ, Krafft CE, Schwarz NF, Chi L, Rodrigue AL, Pierce JE, Allison JD, Yanasak NE, Liu T, Davis CL, McDowell JE. The relationship between uncinate fasciculus white matter integrity and verbal memory proficiency in children. Neuroreport. 2014 Aug 20;25(12):921-5. doi: 10.1097/WNR.0000000000000204.
• Williams CF, Bustamante EE, Waller JL, Davis CL. Exercise effects on quality of life, mood, and self-worth in overweight children: the SMART randomized controlled trial. Transl Behav Med. 2019 May 16;9(3):451-459. doi: 10.1093/tbm/ibz015.

Helpful Links

• NIH Reporter page for the grant

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: R01HL087923 (U.S. NIH Grant/Contract)