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Exercise & Overweight Children's Cognition

Exercise & Overweight Children's Cognition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02227095
Acronym
SMART
Enrollment
175
Registered
2014-08-27
Start date
2008-05-31
Completion date
2014-04-30
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

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)

Interventions

BEHAVIORALExercise

Heart rate monitors worn by each child at each session

Supervised recreational program with token economy

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Georgia
CollaboratorOTHER
San Francisco State University
CollaboratorOTHER
Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Planning Scale scoresBaseline, 8 months, one-year follow-upThe Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function
Change in functional MRIBaseline, 8 monthsChange in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks

Secondary

MeasureTime frameDescription
Change in aerobic fitnessBaseline, 8 months, one-year follow-upVO2 peak via treadmill test
Change in Tower of London scoresBaseline, 8 months, one-year follow-upIndividually administered standardized psychological assessment of executive function
Change in teacher ratings of classroom behaviorBaseline, 8 monthsBehavior Rating Inventory for Executive Functions-Teacher form
Change in academic achievementBaseline, 8 months, one-year follow-upWoodcock-Johnson Test of Achievement III
Change in performance on executive function tasksBaseline, 8 monthsAntisaccade and flanker tasks - error rates, interference effect
Change in BMIBaseline, 8 months, one-year follow-upBMI and BMI z-score, per current norms, will be calculated
Change in adiposityBaseline, 8 months, one-year follow-upPercent fat via whole-body dual-energy x-ray absorptiometry

Other

MeasureTime frameDescription
Points earned during the intervention8 monthsPoints earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.
Average heart rate during the exercise intervention8 monthsPolar 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.
Attendance to the interventions8 months
Change in physical activity outside the programBaseline, 8 months, one-year follow-upYouth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026