<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/NCT01699295</url>
  </required_header>
  <id_info>
    <org_study_id>13460</org_study_id>
    <nct_id>NCT01699295</nct_id>
  </id_info>
  <brief_title>Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)</brief_title>
  <acronym>A+PAAC</acronym>
  <official_title>Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph Donnelly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is currently considerable interest in both improving academic achievement (No Child&#xD;
      Left Behind) and reducing the rates of obesity and its associated negative health&#xD;
      consequences in elementary school students. Increased physical activity (PA) offers a&#xD;
      potential intervention to address both issues. Evidence is available which suggests an&#xD;
      association of PA with both academic achievement and obesity, and an association between&#xD;
      obesity and academic achievement.&#xD;
&#xD;
      To provide increased PA while maintaining academic instruction time, we developed a program&#xD;
      we call &quot;Physical Activity Across the Curriculum&quot; (PAAC) in which regular classroom teachers&#xD;
      were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)&#xD;
      for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between&#xD;
      students in elementary schools that participate in academic lessons taught through MVPA&#xD;
      (PAAC) to students that do not (CON).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Academic Achievement in Elementary Students</measure>
    <time_frame>Baseline to 3 Years</time_frame>
    <description>Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Cognitive Function</measure>
    <time_frame>Baseline to 3 Years</time_frame>
    <description>Changes in attentional control and academic achievement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline to 3 Years</time_frame>
    <description>Change in the BMI over course of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular (CV) Fitness and Daily Physical Activity (PA)</measure>
    <time_frame>Baseline to 3 Years</time_frame>
    <description>Changes in CV Fitness and PA and its impact on cognitive control of attention and academic achievement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Attention-to-Task</measure>
    <time_frame>Baseline to 3 Years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">584</enrollment>
  <condition>Intelligence</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>A+PAAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lessons delivered using A+PAAC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CON</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular sedentary lessons</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A+PAAC</intervention_name>
    <description>academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.</description>
    <arm_group_label>A+PAAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CON</intervention_name>
    <description>lessons taught by regular classroom teachers using traditional/regular sedentary lessons</description>
    <arm_group_label>CON</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade 2 or 3 Student at one of the randomly selected elementary schools&#xD;
&#xD;
          -  Students that agree to complete assessments&#xD;
&#xD;
          -  Signed parental consent form&#xD;
&#xD;
          -  Signed child assent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students that do not agree to complete assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Donnelly, EDD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>January 9, 2016</last_update_submitted>
  <last_update_submitted_qc>January 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Joseph Donnelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>academic achievement</keyword>
  <keyword>elementary school</keyword>
  <keyword>physical activity</keyword>
  <keyword>exercise</keyword>
  <!-- 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/NCT01699295
org study id: 13460
nct id: NCT01699295
lead sponsor: 
has dmc: No
There is currently considerable interest in both improving academic achievement (No Child
      Left Behind) and reducing the rates of obesity and its associated negative health
      consequences in elementary school students. Increased physical activity (PA) offers a
      potential intervention to address both issues. Evidence is available which suggests an
      association of PA with both academic achievement and obesity, and an association between
      obesity and academic achievement.

      To provide increased PA while maintaining academic instruction time, we developed a program
      we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers
      were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)
      for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between
      students in elementary schools that participate in academic lessons taught through MVPA
      (PAAC) to students that do not (CON).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Changes in Academic Achievement in Elementary Students
time frame: Baseline to 3 Years
description: Changes in academic achievement between students in elementary schools that participate in a program that delivers academic lessons taught through MVPA (A+PAAC) to students in elementary schools that do not receive academic lessons taught through MVPA (CON)
measure: Assessment of Cognitive Function
time frame: Baseline to 3 Years
description: Changes in attentional control and academic achievement
measure: Body Mass Index (BMI)
time frame: Baseline to 3 Years
description: Change in the BMI over course of the study.
measure: Cardiovascular (CV) Fitness and Daily Physical Activity (PA)
time frame: Baseline to 3 Years
description: Changes in CV Fitness and PA and its impact on cognitive control of attention and academic achievement
measure: Change in Attention-to-Task
time frame: Baseline to 3 Years
arm group label: A+PAAC
arm group type: Experimental
description: Lessons delivered using A+PAAC
arm group label: CON
arm group type: Active Comparator
description: Regular sedentary lessons
intervention type: Behavioral
intervention name: A+PAAC
description: academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.
arm group label: A+PAAC
intervention type: Behavioral
intervention name: CON
description: lessons taught by regular classroom teachers using traditional/regular sedentary lessons
arm group label: CON
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Donnelly, EDD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Joseph Donnelly
investigator title: Professor