NCT01334359

Brief Summary

Recent trends have identified decreasing levels of physical activity, fitness, and health in preadolescent children. Examining factors, such as physical activity behavior and aerobic fitness that positively influence cognitive health of school-age children are important for improving school performance, maximizing health, and improving the overall functioning of individuals as they progress through the human lifespan. A sample of preadolescent children from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month afterschool program that focuses on either aerobic exercise or wait-list control group to determine the effects of physical activity on basic and applied aspects of cognition. Changes in neuroimaging and behavioral indices of cognitive function and performance on standardized academic achievement tests of mathematics and reading will be examined as a function of participation in the intervention. Preliminary research supports that physical activity is positively associated with basic and applied aspects of cognition, with a stronger relationship for tasks requiring extensive amounts of executive control. However, previous research has mainly focused on older adults, and little research has examined the relationship between physical activity and executive control in children. These findings will provide lifestyle considerations for children to improve their cognitive health across the lifespan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

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

July 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

3.9 years

First QC Date

April 8, 2011

Last Update Submit

July 23, 2014

Conditions

Brain HealthCognitionScholastic Achievement

Keywords

physical activityfitnessbrain healthcognitionscholastic achievementpreadolescent children

Outcome Measures

Primary Outcomes (3)

  • Event-related brain potentials

    Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event.

    Change from baseline, 36-40 weeks

  • Task Performance

    Measures of responses speed and accuracy

    Change from baseline, 36-40 weeks

  • Academic Achievement

    Scholastic achievement tests of reading comprehension and arithmetic.

    Change from baseline, 36-40 weeks

Secondary Outcomes (6)

  • Magnetic Resonance Imaging

    Change from baseline, 36-40 weeks

  • functional Magnetic Resonance Imaging

    Change from baseline, 36-40 weeks

  • Eye Tracking

    Change from baseline, 36-40 weeks

  • Virtual Reality

    Change from baseline, 36-40 weeks)

  • Adiposity

    Change from baseline, 36-40 weeks

  • +1 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants randomized to the afterschool intervention

Behavioral: Physical Activity

Wait List Group

PLACEBO COMPARATOR

Participants in this group partake in their regular afterschool activities, without intervention from the study staff.

Behavioral: Physical Activity

Interventions

Physical ActivityBEHAVIORAL

9-month afterschool program designed to increase physical activity and aerobic fitness.

Treatment GroupWait List Group

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental consent
  • years
  • Capable of performing exercise
  • Absence of school-identified learning disability
  • IQ \> 85
  • Tanner Scales score \<= 2
  • ADHD Rating Scales score \> 85%

You may not qualify if:

  • Non-consent of guardian
  • Above or Below age range
  • Any physical disability that prohibits exercise
  • School-identified learning disability
  • IQ \< 85
  • Tanner Scales Score \> 2
  • ADHD Rating Scale score \< 85%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (6)

  • Logan NE, Westfall DR, Raine LB, Anteraper SA, Chaddock-Heyman L, Whitfield-Gabrieli S, Kramer AF, Hillman CH. The Differential Effects of Adiposity and Fitness on Functional Connectivity in Preadolescent Children. Med Sci Sports Exerc. 2022 Oct 1;54(10):1702-1713. doi: 10.1249/MSS.0000000000002964. Epub 2022 Jun 24.

    PMID: 35763600DERIVED

  • Chojnacki MR, Holscher HD, Balbinot AR, Raine LB, Biggan JR, Walk AM, Kramer AF, Cohen NJ, Hillman CH, Khan NA. Relations between mode of birth delivery and timing of developmental milestones and adiposity in preadolescence: A retrospective study. Early Hum Dev. 2019 Feb;129:52-59. doi: 10.1016/j.earlhumdev.2018.12.021. Epub 2019 Jan 12.

    PMID: 30641478DERIVED

  • Raine LB, Khan NA, Drollette ES, Pontifex MB, Kramer AF, Hillman CH. Obesity, Visceral Adipose Tissue, and Cognitive Function in Childhood. J Pediatr. 2017 Aug;187:134-140.e3. doi: 10.1016/j.jpeds.2017.05.023. Epub 2017 Jun 13.

    PMID: 28622956DERIVED

  • Hillman CH, Pontifex MB, Castelli DM, Khan NA, Raine LB, Scudder MR, Drollette ES, Moore RD, Wu CT, Kamijo K. Effects of the FITKids randomized controlled trial on executive control and brain function. Pediatrics. 2014 Oct;134(4):e1063-71. doi: 10.1542/peds.2013-3219.

    PMID: 25266425DERIVED

  • Khan NA, Raine LB, Drollette ES, Scudder MR, Pontifex MB, Castelli DM, Donovan SM, Evans EM, Hillman CH. Impact of the FITKids physical activity intervention on adiposity in prepubertal children. Pediatrics. 2014 Apr;133(4):e875-83. doi: 10.1542/peds.2013-2246. Epub 2014 Mar 31.

    PMID: 24685956DERIVED

  • Baym CL, Khan NA, Monti JM, Raine LB, Drollette ES, Moore RD, Scudder MR, Kramer AF, Hillman CH, Cohen NJ. Dietary lipids are differentially associated with hippocampal-dependent relational memory in prepubescent children. Am J Clin Nutr. 2014 May;99(5):1026-32. doi: 10.3945/ajcn.113.079624. Epub 2014 Feb 12.

    PMID: 24522447DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Charles H Hillman, PHD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 13, 2011

Study Start

July 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 25, 2014

Record last verified: 2014-07

Locations

US(1)