Cognitive Ability, GeneralFITKids2NCT01619826
Enhancing Children's Cognitive and Brain Health Through Physical Activity Training (FITKids2)
A study testing Physical Activity in people with Cognitive Ability, General and Achievement, run by University of Illinois at Urbana-Champaign at 4 sites in United States.
Trial summary
The objective of this study is to use a randomized controlled design to determine whether cardiorespiratory fitness training improves neurocognitive function and academic performance during preadolescent development. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General, Achievement
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2012to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental/guardian consent
- 8 - 9 years old
- Capable of performing exercise
- Absence of school-identified learning disability
- IQ >= 85
- Tanner Scales score <= 2
Show all 10Show fewer
- ADHD Rating Scales score >= 85%
- Right hand dominant
- Absence of metal implants
- Not claustrophobic
Who cannot join
- Non-consent of guardian
- Above or below 8 - 9 years old
- Any physical disability that prohibits exercise
- School-identified learning disability
- IQ < 85
- Tanner Scales score > 2
Show all 10Show fewer
- ADHD Rating Scale score < 85%
- Left hand dominant
- Presence of metal implants
- Claustrophobic
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beckman Institute - Biomedical Imaging Center
Urbana, Illinois, 61801
Campus Recreation Center East
Urbana, Illinois, 61801
Department of Kinesiology and Community Health
Urbana, Illinois, 61801
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Enhancing Children's Cognitive and Brain Health Through Physical Activity Training
The objective of this study is to use a randomized controlled design to determine whether cardiorespiratory fitness training improves neurocognitive function and academic performance during preadolescent development.
Read the detailed description
The long term objective of this project is to develop an understanding of lifestyle factors that influence the cognitive and brain health of children while also reducing the sedentary nature of today's youth. Previous research has found that physical activity interventions can enhance both a variety of aspects of cognition and brain structure and function of children, older adults, and individuals with neurodegenerative disorders such as Parkinson's disease and multiple sclerosis. More specifically, in previous research with children the researchers have found that higher fit children possess larger hippocampi which in turn are related to better relational memory than their lower fit counterparts. The researchers have also observed that higher fit children exhibit more efficient executive control as indicated by performance measures and event-related brain potentials. While intriguing, these cross-sectional data do not enable us to establish causality between physical activity and cognition. In the current study the researchers substantially extend this previous research by examining the influence of a 9 month randomized controlled afterschool physical activity program on cognition and brain health. Cognition will be assessed with a battery of tasks and standardized achievement tests both before and after the 9 month intervention in the activity group and a wait list control (who will receive the intervention the following year). Children will also participate in magnetic resonance imaging (MRI) sessions both before and after the intervention (and at comparable times for the wait list control). In these sessions the researchers will measure both structural aspects of the brain including regional volumes of gray matter and the integrity of the white matter tracts (through diffusion tensor imaging) and functional aspects of brain function using fMRI activity recorded as the children perform a series of executive control and memory tasks. The researchers anticipate, based on our cross-sectional studies with children and our previous longitudinal studies with older adults, that the children in the physical activity program will show both larger regional brain volumes, particularly in brain regions that subserve executive control and relational memory, and more efficient brain function, as indexed by task-related and resting state fMRI. Furthermore, the researchers anticipate that these changes will be accompanied by improvements in memory and executive control processes. Given recent trends identifying decreased levels of physical activity and health status in preadolescents, the understanding of the potential benefits of physical activity on cognition is of great interest. It is imperative that factors positively influencing cognitive function of children be examined to maximize health and effective functioning of individuals as they progress through the lifespan.
- Conditions
- Cognitive Ability, General, Achievement
- Being tested
- Physical Activity
- Keywords
- physical activity, fitness, brain health, cognition, scholastic achievement, preadolescent children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
9-month afterschool program designed to increase physical activity and aerobic fitness.
Physical ActivityBehavioural
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants randomized to the physical activity-based afterschool intervention Receives: Behavioral: Physical Activity |
| Wait List Group | Placebo comparator | Participants in this group partake in their regular afterschool activities, without intervention from the study staff. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeuroCognitive Assessment
Normed computerized test battery for cognitive testing
Measured: Change from baseline, 36 - 40 weeks
Structural Magnetic Resonance Imaging
Measures of brain structure
Measured: Change from baseline, 36 - 40 weeks
Functional Magnetic Resonance Imaging
Measures of brain function
Measured: Change from baseline, 36 - 40 weeks
Academic Achievement
Scholastic achievement tests of reading comprehension and arithmetic
Measured: Change from baseline, 36 - 40 weeks
Eye Tracking
Measures of visual gaze
Measured: Change from baseline, 36 - 40 weeks
Task Performance
Measures of responses speed and accuracy
Measured: Change from baseline, 36 - 40 weeks
Secondary outcomes (4)
Event-related Brain Potentials
Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event
Measured: Change from baseline, 36 - 40 weeks
DXA Body Mass Assessment
Measures of bone density, total body composition, and fat content
Measured: Change from baseline, 36 - 40 weeks
Diet and Brain Function
Measure of correlation between diet and brain function
Measured: Change from baseline, 36-40 weeks
Adiposity
Measure of change in adiposity
Measured: Change from baseline, 36 - 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Arthur F Kramer, PhD, Principal investigator, University of Illinois at Urbana-ChampaignCharles Hillman, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619826
- Sponsor's protocol ID
- HD069381
- Other IDs
- R01HD069381-01A1
- Acronym
- FITKids2
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2012
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu R, Hannon BA, Robinson KN, Raine LB, Hammond BR, Renzi-Hammond LM, Cohen NJ, Kramer AF, Hillman CH, Teran-Garcia M, Khan NA. Single Nucleotide Polymorphisms in CD36 Are Associated with Macular Pigment among Children. J Nutr. 2021 Sep 4;151(9):2533-2540. doi: 10.1093/jn/nxab153.
PubMed 34049394Chojnacki 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.
PubMed 30641478Chojnacki MR, Raine LB, Drollette ES, Scudder MR, Kramer AF, Hillman CH, Khan NA. The Negative Influence of Adiposity Extends to Intraindividual Variability in Cognitive Control Among Preadolescent Children. Obesity (Silver Spring). 2018 Feb;26(2):405-411. doi: 10.1002/oby.22053. Epub 2017 Dec 27.
PubMed 29282881Raine 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.
PubMed 28622956Barnett SM, Khan NA, Walk AM, Raine LB, Moulton C, Cohen NJ, Kramer AF, Hammond BR Jr, Renzi-Hammond L, Hillman CH. Macular pigment optical density is positively associated with academic performance among preadolescent children. Nutr Neurosci. 2018 Nov;21(9):632-640. doi: 10.1080/1028415X.2017.1329976. Epub 2017 May 23.
PubMed 28535707Hassevoort KM, Khazoum SE, Walker JA, Barnett SM, Raine LB, Hammond BR, Renzi-Hammond LM, Kramer AF, Khan NA, Hillman CH, Cohen NJ. Macular Carotenoids, Aerobic Fitness, and Central Adiposity Are Associated Differentially with Hippocampal-Dependent Relational Memory in Preadolescent Children. J Pediatr. 2017 Apr;183:108-114.e1. doi: 10.1016/j.jpeds.2017.01.016. Epub 2017 Feb 8.
PubMed 28189300Baym 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.
PubMed 24522447
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Children's Cognitive and Brain Health Through Physical Activity Training
- ClinicalTrials.gov ID
- NCT01619826
- Acronym / sponsor ID
- FITKids2 / HD069381
- Conditions
- Cognitive Ability, General, Achievement
- Keywords
- physical activity, fitness, brain health, cognition, scholastic achievement, preadolescent children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to use a randomized controlled design to determine whether cardiorespiratory fitness training improves neurocognitive function and academic performance during preadolescent development.
Detailed description
The long term objective of this project is to develop an understanding of lifestyle factors that influence the cognitive and brain health of children while also reducing the sedentary nature of today's youth. Previous research has found that physical activity interventions can enhance both a variety of aspects of cognition and brain structure and function of children, older adults, and individuals with neurodegenerative disorders such as Parkinson's disease and multiple sclerosis. More specifically, in previous research with children the researchers have found that higher fit children possess larger hippocampi which in turn are related to better relational memory than their lower fit counterparts. The researchers have also observed that higher fit children exhibit more efficient executive control as indicated by performance measures and event-related brain potentials. While intriguing, these cross-sectional data do not enable us to establish causality between physical activity and cognition. In the current study the researchers substantially extend this previous research by examining the influence of a 9 month randomized controlled afterschool physical activity program on cognition and brain health. Cognition will be assessed with a battery of tasks and standardized achievement tests both before and after the 9 month intervention in the activity group and a wait list control (who will receive the intervention the following year). Children will also participate in magnetic resonance imaging (MRI) sessions both before and after the intervention (and at comparable times for the wait list control). In these sessions the researchers will measure both structural aspects of the brain including regional volumes of gray matter and the integrity of the white matter tracts (through diffusion tensor imaging) and functional aspects of brain function using fMRI activity recorded as the children perform a series of executive control and memory tasks. The researchers anticipate, based on our cross-sectional studies with children and our previous longitudinal studies with older adults, that the children in the physical activity program will show both larger regional brain volumes, particularly in brain regions that subserve executive control and relational memory, and more efficient brain function, as indexed by task-related and resting state fMRI. Furthermore, the researchers anticipate that these changes will be accompanied by improvements in memory and executive control processes. Given recent trends identifying decreased levels of physical activity and health status in preadolescents, the understanding of the potential benefits of physical activity on cognition is of great interest. It is imperative that factors positively influencing cognitive function of children be examined to maximize health and effective functioning of individuals as they progress through the lifespan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Physical ActivityParticipants randomized to the physical activity-based afterschool intervention |
| Wait List Group | Placebo comparator | Behavioral: Physical ActivityParticipants in this group partake in their regular afterschool activities, without intervention from the study staff. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Parental/guardian consent
- 8 - 9 years old
- Capable of performing exercise
- Absence of school-identified learning disability
- IQ >= 85
Key exclusion criteria (10 listed)
- Non-consent of guardian
- Above or below 8 - 9 years old
- Any physical disability that prohibits exercise
- School-identified learning disability
- IQ < 85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity9-month afterschool program designed to increase physical activity and aerobic fitness. | Behavioural | Treatment Group |
| Physical ActivityParticipants in this group partake in their regular afterschool activities, without intervention from the study staff. | Behavioural | Wait List Group |
Primary outcome
NeuroCognitive Assessment
Time frame: Change from baseline, 36 - 40 weeks
Normed computerized test battery for cognitive testing
Structural Magnetic Resonance Imaging
Time frame: Change from baseline, 36 - 40 weeks
Measures of brain structure
Functional Magnetic Resonance Imaging
Time frame: Change from baseline, 36 - 40 weeks
Measures of brain function
Academic Achievement
Time frame: Change from baseline, 36 - 40 weeks
Scholastic achievement tests of reading comprehension and arithmetic
Eye Tracking
Time frame: Change from baseline, 36 - 40 weeks
Measures of visual gaze
Task Performance
Time frame: Change from baseline, 36 - 40 weeks
Measures of responses speed and accuracy
4 secondary outcomes
Event-related Brain Potentials
Time frame: Change from baseline, 36 - 40 weeks
DXA Body Mass Assessment
Time frame: Change from baseline, 36 - 40 weeks
Diet and Brain Function
Time frame: Change from baseline, 36-40 weeks
Adiposity
Time frame: Change from baseline, 36 - 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Derived from this study: PubMed 34049394Liu R, Hannon BA, Robinson KN, Raine LB, Hammond BR, Renzi-Hammond LM, Cohen NJ, Kramer AF, Hillman CH, Teran-Garcia M, Khan NA. Single Nucleotide Polymorphisms in CD36 Are Associated with Macular Pigment among Children. J Nutr. 2021 Sep 4;151(9):2533-2540. doi: 10.1093/jn/nxab153.
- Derived from this study: PubMed 30641478Chojnacki 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.
- Derived from this study: PubMed 29282881Chojnacki MR, Raine LB, Drollette ES, Scudder MR, Kramer AF, Hillman CH, Khan NA. The Negative Influence of Adiposity Extends to Intraindividual Variability in Cognitive Control Among Preadolescent Children. Obesity (Silver Spring). 2018 Feb;26(2):405-411. doi: 10.1002/oby.22053. Epub 2017 Dec 27.
- Derived from this study: PubMed 28622956Raine 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.
- Derived from this study: PubMed 28535707Barnett SM, Khan NA, Walk AM, Raine LB, Moulton C, Cohen NJ, Kramer AF, Hammond BR Jr, Renzi-Hammond L, Hillman CH. Macular pigment optical density is positively associated with academic performance among preadolescent children. Nutr Neurosci. 2018 Nov;21(9):632-640. doi: 10.1080/1028415X.2017.1329976. Epub 2017 May 23.
- Derived from this study: PubMed 28189300Hassevoort KM, Khazoum SE, Walker JA, Barnett SM, Raine LB, Hammond BR, Renzi-Hammond LM, Kramer AF, Khan NA, Hillman CH, Cohen NJ. Macular Carotenoids, Aerobic Fitness, and Central Adiposity Are Associated Differentially with Hippocampal-Dependent Relational Memory in Preadolescent Children. J Pediatr. 2017 Apr;183:108-114.e1. doi: 10.1016/j.jpeds.2017.01.016. Epub 2017 Feb 8.
- Derived from this study: PubMed 24522447Baym 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.
- FITKids WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur F Kramer, PhD principal investigator
University of Illinois at Urbana-Champaign
Charles Hillman, PhD principal investigator
University of Illinois at Urbana-Champaign
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Cognitive Ability, General and Achievement, run by University of Illinois at Urbana-Champaign at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NeuroCognitive Assessment (time frame: Change from baseline, 36 - 40 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01619826, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.