Exercise & Overweight Children's Cognition

Overweight and Obesity Clinical Trial

— SMART  

Official title:

Exercise & Overweight Children's Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227095
• Other study ID #: R01HL087923
• Secondary ID: R01HL087923
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: March 4, 2015
• Start date: May 2008
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

Description:

An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1, http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&icde=20104167)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Exercise
Heart rate monitors worn by each child at each session
• After-school program
Supervised recreational program with token economy

Locations

Country	Name	City	State
United States	Georgia Prevention Institute	Augusta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Georgia Regents University	National Heart, Lung, and Blood Institute (NHLBI), San Francisco State University, University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 ch — View 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 — View 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 c — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity outside the program	Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months	Baseline, 8 months, one-year follow-up	No
Other	Attendance to the interventions		8 months	No
Other	Average heart rate during the exercise intervention	Polar 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.	8 months	No
Other	Points earned during the intervention	Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.	8 months	No
Primary	Change in Planning Scale scores	The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function	Baseline, 8 months, one-year follow-up	No
Primary	Change in functional MRI	Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks	Baseline, 8 months	No
Secondary	Change in BMI	BMI and BMI z-score, per current norms, will be calculated	Baseline, 8 months, one-year follow-up	No
Secondary	Change in adiposity	Percent fat via whole-body dual-energy x-ray absorptiometry	Baseline, 8 months, one-year follow-up	No
Secondary	Change in aerobic fitness	VO2 peak via treadmill test	Baseline, 8 months, one-year follow-up	No
Secondary	Change in Tower of London scores	Individually administered standardized psychological assessment of executive function	Baseline, 8 months, one-year follow-up	No
Secondary	Change in teacher ratings of classroom behavior	Behavior Rating Inventory for Executive Functions-Teacher form	Baseline, 8 months	No
Secondary	Change in academic achievement	Woodcock-Johnson Test of Achievement III	Baseline, 8 months, one-year follow-up	No
Secondary	Change in performance on executive function tasks	Antisaccade and flanker tasks - error rates, interference effect	Baseline, 8 months	No

External Links

•   NIH Reporter page for the grant