NCT02227095

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

April 23, 2014

Last Update Submit

March 4, 2015

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Change in BMI

    Baseline, 8 months, one-year follow-up

  • Change in adiposity

    Baseline, 8 months, one-year follow-up

  • Change in aerobic fitness

    Baseline, 8 months, one-year follow-up

  • Change in Tower of London scores

    Baseline, 8 months, one-year follow-up

  • Change in teacher ratings of classroom behavior

    Baseline, 8 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Change in physical activity outside the program

    Baseline, 8 months, one-year follow-up

  • Attendance to the interventions

    8 months

  • Average heart rate during the exercise intervention

    8 months

  • +1 more other outcomes

Study Arms (2)

After-school exercise program

EXPERIMENTAL

40 min/day vigorous aerobic games after school

Behavioral: ExerciseBehavioral: After-school program

Sedentary after-school program

ACTIVE COMPARATOR

Attention-control condition similar to experimental condition with the exception of exercise

Behavioral: After-school program

Interventions

ExerciseBEHAVIORAL

Heart rate monitors worn by each child at each session

Also known as: Aerobic training
After-school exercise program
After-school programBEHAVIORAL

Supervised recreational program with token economy

After-school exercise programSedentary after-school program

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

Location

Related Publications (6)

  • 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.

    PMID: 23788510RESULT

  • 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.

    PMID: 24096138RESULT

  • 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.

    PMID: 24457421RESULT

  • 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.

    PMID: 24797659RESULT

  • 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.

    PMID: 24949818RESULT

  • 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.

    PMID: 31094443DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Catherine L Davis, PhD

    Medical College of Georgia, Georgia Regents University

    PRINCIPAL INVESTIGATOR

  • Jennifer E McDowell, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Physiology & Graduate Studies

Study Record Dates

First Submitted

April 23, 2014

First Posted

August 27, 2014

Study Start

May 1, 2008

Primary Completion

May 1, 2013

Study Completion

April 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)