Clinical trial NCT02227095: Exercise & Overweight Children's Cognition
Official title: Exercise & Overweight Children's Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Georgia
name: San Francisco State University
First posted: 2014-08-27
Enrollment: 175
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Planning Scale scores
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in functional MRI
timeFrame: Baseline, 8 months
Secondary outcomes:
measure: Change in BMI
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in adiposity
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in aerobic fitness
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in Tower of London scores
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in teacher ratings of classroom behavior
timeFrame: Baseline, 8 months
measure: Change in academic achievement
timeFrame: Baseline, 8 months, one-year follow-up
measure: Change in performance on executive function tasks
timeFrame: Baseline, 8 months
Other outcomes:
measure: Change in physical activity outside the program
timeFrame: Baseline, 8 months, one-year follow-up
measure: Attendance to the interventions
timeFrame: 8 months
measure: Average heart rate during the exercise intervention
timeFrame: 8 months
measure: Points earned during the intervention
timeFrame: 8 months
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Medical College of Georgia, Georgia Regents University
name: Catherine L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Georgia
name: Jennifer E McDowell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.