Overweight and ObesitySMARTNCT02227095
Exercise & Overweight Children's Cognition
A study testing Exercise and After-school program in people with Overweight and Obesity, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise and After-school program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Apr 2014
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-11 years of age
- Overweight or obese (BMI-for-age >= 85th percentile)
- Able to participate in exercise testing and intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute
Augusta, Georgia, 30912
About this study
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.
Read the 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)
- Conditions
- Overweight and Obesity
- Being tested
- Exercise, After-school program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Aerobic training
Heart rate monitors worn by each child at each session
After-school programBehavioural
Supervised recreational program with token economy
| Study group | Role | What they receive |
|---|---|---|
| After-school exercise program | Experimental | 40 min/day vigorous aerobic games after school Receives: Behavioral: Exercise; Behavioral: After-school program |
| Sedentary after-school program | Active comparator | Attention-control condition similar to experimental condition with the exception of exercise Receives: Behavioral: After-school program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Planning Scale scores
The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function
Measured: 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
Measured: Baseline, 8 months
Secondary outcomes (7)
Change in BMI
BMI and BMI z-score, per current norms, will be calculated
Measured: Baseline, 8 months, one-year follow-up
Change in adiposity
Percent fat via whole-body dual-energy x-ray absorptiometry
Measured: Baseline, 8 months, one-year follow-up
Change in aerobic fitness
VO2 peak via treadmill test
Measured: Baseline, 8 months, one-year follow-up
Change in Tower of London scores
Individually administered standardized psychological assessment of executive function
Measured: Baseline, 8 months, one-year follow-up
Change in teacher ratings of classroom behavior
Behavior Rating Inventory for Executive Functions-Teacher form
Measured: Baseline, 8 months
Change in academic achievement
Woodcock-Johnson Test of Achievement III
Measured: Baseline, 8 months, one-year follow-up
Change in performance on executive function tasks
Antisaccade and flanker tasks - error rates, interference effect
Measured: Baseline, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMay 2008
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Georgia, San Francisco State University
- Responsible party
- Principal investigator, Catherine Davis, Augusta University
- Investigators
- Catherine L Davis, PhD, Principal investigator, Medical College of Georgia, Georgia Regents UniversityJennifer E McDowell, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227095
- Sponsor's protocol ID
- R01HL087923
- Other IDs
- R01HL087923
- Acronym
- SMART
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23788510Krafft 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.
PubMed 24096138Krafft 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.
PubMed 24457421Schaeffer 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.
PubMed 24797659Schaeffer 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.
PubMed 24949818Williams 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.
PubMed 31094443
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise & Overweight Children's Cognition
- ClinicalTrials.gov ID
- NCT02227095
- Acronym / sponsor ID
- SMART / R01HL087923
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Georgia, San Francisco State University
- Study start
- May 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Aug 2014 (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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After-school exercise program | Experimental | Behavioral: Exercise, Behavioral: After-school program40 min/day vigorous aerobic games after school |
| Sedentary after-school program | Active comparator | Behavioral: After-school programAttention-control condition similar to experimental condition with the exception of exercise |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-11 years of age
- Overweight or obese (BMI-for-age >= 85th percentile)
- Able to participate in exercise testing and intervention
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| ExerciseAlso: Aerobic trainingHeart rate monitors worn by each child at each session | Behavioural | After-school exercise program |
| After-school programSupervised recreational program with token economy | Behavioural | After-school exercise program, Sedentary after-school program |
Primary outcome
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
Change in functional MRI
Time frame: Baseline, 8 months
Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks
7 secondary outcomes
Change in BMI
Time frame: Baseline, 8 months, one-year follow-up
Change in adiposity
Time frame: Baseline, 8 months, one-year follow-up
Change in aerobic fitness
Time frame: Baseline, 8 months, one-year follow-up
Change in Tower of London scores
Time frame: Baseline, 8 months, one-year follow-up
Change in teacher ratings of classroom behavior
Time frame: Baseline, 8 months
Change in academic achievement
Time frame: Baseline, 8 months, one-year follow-up
Change in performance on executive function tasks
Time frame: Baseline, 8 months
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 6 Mar 2015.
- Results publication: PubMed 23788510Krafft 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.
- Results publication: PubMed 24096138Krafft 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.
- Results publication: PubMed 24457421Krafft 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.
- Results publication: PubMed 24797659Schaeffer 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.
- Results publication: PubMed 24949818Schaeffer 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.
- Derived from this study: PubMed 31094443Williams 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.
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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.
Catherine L Davis, PhD principal investigator
Medical College of Georgia, Georgia Regents University
Jennifer E McDowell, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and After-school program in people with Overweight and Obesity, run by Augusta University at 1 site 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 3 inclusion and 3 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Change in Planning Scale scores (time frame: Baseline, 8 months, one-year follow-up). The study lists 2 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 NCT02227095, which also lists 6 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 6 Mar 2015.