<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/NCT03015337</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00088758</org_study_id>
    <nct_id>NCT03015337</nct_id>
  </id_info>
  <brief_title>Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students</brief_title>
  <official_title>Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examined how well elementary students demonstrated motor skill competency as a&#xD;
      result of participating in the evidence-based quality physical education program and&#xD;
      investigated relationships between levels of health-related physical fitness and physical&#xD;
      activity in school-aged children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Running skill assessment</measure>
    <time_frame>2 years</time_frame>
    <description>changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight transferring skill assessment</measure>
    <time_frame>2 years</time_frame>
    <description>changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hand dribbling skill assessment</measure>
    <time_frame>2 years</time_frame>
    <description>changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>underhand catching skill assessment</measure>
    <time_frame>2 years</time_frame>
    <description>changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FitnessGram test</measure>
    <time_frame>1 year</time_frame>
    <description>Relationship between fitness and physical activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily physical activity participation in minutes</measure>
    <time_frame>1 year</time_frame>
    <description>Relationship between levels of fitness and daily physical activity participation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1844</enrollment>
  <condition>Child Behavior</condition>
  <arm_group>
    <arm_group_label>New Physical Education Instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>New physical education instructions</intervention_name>
    <arm_group_label>New Physical Education Instructions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  K-5 th grade students who are enrolled in 9 elementary schools in Southeast Michigan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiyun Chen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Kinesiology, University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Weiyun Chen</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03015337
org study id: HUM00088758
nct id: NCT03015337
lead sponsor: 
has dmc: Yes
This study examined how well elementary students demonstrated motor skill competency as a
      result of participating in the evidence-based quality physical education program and
      investigated relationships between levels of health-related physical fitness and physical
      activity in school-aged children.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Running skill assessment
time frame: 2 years
description: changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.
measure: Weight transferring skill assessment
time frame: 2 years
description: changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.
measure: hand dribbling skill assessment
time frame: 2 years
description: changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.
measure: underhand catching skill assessment
time frame: 2 years
description: changes in manipulative skill between the intervention year 1 and the intervention year 2. The K-1 students' motor skill competency in running, weight transferring, hand dribbling, and underhand catching skills was assessed using four PE Metrics skill assessment rubrics in the intervention year 1 and year 2, respectively.
measure: FitnessGram test
time frame: 1 year
description: Relationship between fitness and physical activity.
measure: Daily physical activity participation in minutes
time frame: 1 year
description: Relationship between levels of fitness and daily physical activity participation.
arm group label: New Physical Education Instructions
arm group type: Experimental
intervention type: Behavioral
intervention name: New physical education instructions
arm group label: New Physical Education Instructions
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Weiyun Chen, Ph.D.
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Weiyun Chen
investigator title: Associate professor
sharing ipd: No