<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227095</url>
  </required_header>
  <id_info>
    <org_study_id>R01HL087923</org_study_id>
    <secondary_id>R01HL087923</secondary_id>
    <nct_id>NCT02227095</nct_id>
  </id_info>
  <brief_title>Exercise &amp; Overweight Children's Cognition</brief_title>
  <acronym>SMART</acronym>
  <official_title>Exercise &amp; Overweight Children's Cognition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research focuses on overweight, sedentary children whose health, cognition, and academic&#xD;
      performance are therefore at risk, and who may be particularly responsive to exercise&#xD;
      interventions.&#xD;
&#xD;
      This study will determine whether regular exercise per se (i.e. compared to attention&#xD;
      control, or placebo, condition) benefits children's cognition and achievement, and will&#xD;
      provide insight into neural mechanisms. A substudy will examine exercise-induced changes in&#xD;
      brain structure.&#xD;
&#xD;
      Provision of comprehensive evidence for the benefits of exercise on children's health may&#xD;
      reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by&#xD;
      persuading policymakers, schools and communities that time spent in physical activity&#xD;
      enhances, rather than detracts from, learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1,&#xD;
      http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&amp;icde=20104167)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Planning Scale scores</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in functional MRI</measure>
    <time_frame>Baseline, 8 months</time_frame>
    <description>Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>BMI and BMI z-score, per current norms, will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adiposity</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>Percent fat via whole-body dual-energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aerobic fitness</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>VO2 peak via treadmill test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tower of London scores</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>Individually administered standardized psychological assessment of executive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in teacher ratings of classroom behavior</measure>
    <time_frame>Baseline, 8 months</time_frame>
    <description>Behavior Rating Inventory for Executive Functions-Teacher form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in academic achievement</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>Woodcock-Johnson Test of Achievement III</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on executive function tasks</measure>
    <time_frame>Baseline, 8 months</time_frame>
    <description>Antisaccade and flanker tasks - error rates, interference effect</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in physical activity outside the program</measure>
    <time_frame>Baseline, 8 months, one-year follow-up</time_frame>
    <description>Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Attendance to the interventions</measure>
    <time_frame>8 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Average heart rate during the exercise intervention</measure>
    <time_frame>8 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Points earned during the intervention</measure>
    <time_frame>8 months</time_frame>
    <description>Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>After-school exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 min/day vigorous aerobic games after school</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sedentary after-school program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attention-control condition similar to experimental condition with the exception of exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Heart rate monitors worn by each child at each session</description>
    <arm_group_label>After-school exercise program</arm_group_label>
    <other_name>Aerobic training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>After-school program</intervention_name>
    <description>Supervised recreational program with token economy</description>
    <arm_group_label>After-school exercise program</arm_group_label>
    <arm_group_label>Sedentary after-school program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  8-11 years of age&#xD;
&#xD;
          -  Overweight or obese (BMI-for-age &gt;= 85th percentile)&#xD;
&#xD;
          -  Able to participate in exercise testing and intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical condition or medications that would interfere with measurements&#xD;
&#xD;
          -  Participation in weight control or formal exercise program outside physical education&#xD;
             that meets more than 1 day/week&#xD;
&#xD;
          -  T-score &gt; 75 on the BRIEF Behavior Regulation scale to avoid program disruption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine L Davis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Georgia, Georgia Regents University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer E McDowell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Georgia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgia Prevention Institute</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://projectreporter.nih.gov/project_info_description.cfm?aid=7525032&amp;icde=20104167</url>
    <description>NIH Reporter page for the grant</description>
  </link>
  <results_reference>
    <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>
    <PMID>23788510</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>24096138</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>24457421</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>24797659</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>24949818</PMID>
  </results_reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>April 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Catherine Davis</investigator_full_name>
    <investigator_title>Professor of Pediatrics, Physiology &amp; Graduate Studies</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227095
org study id: R01HL087923
secondary id: R01HL087923
nct id: NCT02227095
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1,
      http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457&icde=20104167)
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Change in Planning Scale scores
time frame: Baseline, 8 months, one-year follow-up
description: The Cognitive Assessment System provides an individually administered standardized psychological assessment of executive function
measure: Change in functional MRI
time frame: Baseline, 8 months
description: Change in blood-oxygenation level dependent (BOLD) signal reflecting brain activation during executive function tasks
measure: Change in BMI
time frame: Baseline, 8 months, one-year follow-up
description: BMI and BMI z-score, per current norms, will be calculated
measure: Change in adiposity
time frame: Baseline, 8 months, one-year follow-up
description: Percent fat via whole-body dual-energy x-ray absorptiometry
measure: Change in aerobic fitness
time frame: Baseline, 8 months, one-year follow-up
description: VO2 peak via treadmill test
measure: Change in Tower of London scores
time frame: Baseline, 8 months, one-year follow-up
description: Individually administered standardized psychological assessment of executive function
measure: Change in teacher ratings of classroom behavior
time frame: Baseline, 8 months
description: Behavior Rating Inventory for Executive Functions-Teacher form
measure: Change in academic achievement
time frame: Baseline, 8 months, one-year follow-up
description: Woodcock-Johnson Test of Achievement III
measure: Change in performance on executive function tasks
time frame: Baseline, 8 months
description: Antisaccade and flanker tasks - error rates, interference effect
measure: Change in physical activity outside the program
time frame: Baseline, 8 months, one-year follow-up
description: Youth Risk Behavior Survey questions at all 3 timepoints, accelerometry at baseline and 8 months
measure: Attendance to the interventions
time frame: 8 months
measure: Average heart rate during the exercise intervention
time frame: 8 months
description: 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.
measure: Points earned during the intervention
time frame: 8 months
description: Points earned for expected behavior will be recorded daily for each child that attends the intervention. Points are redeemed for small prizes weekly.
arm group label: After-school exercise program
arm group type: Experimental
description: 40 min/day vigorous aerobic games after school
arm group label: Sedentary after-school program
arm group type: Active Comparator
description: Attention-control condition similar to experimental condition with the exception of exercise
intervention type: Behavioral
intervention name: Exercise
description: Heart rate monitors worn by each child at each session
arm group label: After-school exercise program
other name: Aerobic training
intervention type: Behavioral
intervention name: After-school program
description: Supervised recreational program with token economy
arm group label: After-school exercise program
arm group label: Sedentary after-school program
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine L Davis, PhD
role: Principal Investigator
affiliation: Medical College of Georgia, Georgia Regents University
last name: Jennifer E McDowell, PhD
role: Principal Investigator
affiliation: University of Georgia
facility: 
country: United States
url: http://projectreporter.nih.gov/project_info_description.cfm?aid=7525032&icde=20104167
description: NIH Reporter page for the grant
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.
PMID: 23788510
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.
PMID: 24096138
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.
PMID: 24457421
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.
PMID: 24797659
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.
PMID: 24949818
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Catherine Davis
investigator title: Professor of Pediatrics, Physiology & Graduate Studies
mesh term: Overweight