<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/NCT03765047</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00095600</org_study_id>
    <secondary_id>74281</secondary_id>
    <nct_id>NCT03765047</nct_id>
  </id_info>
  <brief_title>A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes</brief_title>
  <official_title>A Rigorous Evaluation of the Relationship Between Physical Activity and Education Outcomes in Georgia's Elementary Schools (RWJF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Wood Johnson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective study to examine the impact of a school-based physical activity&#xD;
      intervention on fourth and fifth grade elementary students' academic achievement, as measured&#xD;
      by standardized test scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serving more than 95% of US children ages 5-17, the school environment is a valuable setting&#xD;
      to engage students in Physical Activity (PA) through the day, but is limited when physical&#xD;
      education programs have insufficient curricular, time, financial and staffing allocations. A&#xD;
      growing body of research supports the premise that interventions focused on increasing&#xD;
      physical activity in schools may be more successful if supported by evidence that increased&#xD;
      PA improves academic achievement, that is the clear priority for limited school time and&#xD;
      resources.&#xD;
&#xD;
      The purpose of this study is to examine the impact of a school-based physical activity&#xD;
      intervention on fourth and fifth grade elementary students' academic achievement, as measured&#xD;
      by standardized test scores. Baseline information about current physical activity practices&#xD;
      will be collected. Schools will receive ongoing in-person and virtual training, and schools&#xD;
      will be provided physical activity equipment, resources, and teaching aids. Student&#xD;
      accelerometer data will allow for monitoring of physical activity levels. This study seeks to&#xD;
      address gaps in the literature by studying the efficacy of a well-established intervention&#xD;
      that has been shown to impact school physical activities practices, and shows promise of&#xD;
      efficacy for improving student education outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2018</start_date>
  <completion_date type="Actual">June 19, 2020</completion_date>
  <primary_completion_date type="Actual">June 19, 2020</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Georgia Milestones standardized test scores in math</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies. The tests are scored with four achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels of math are 290-474, 475-524, 525-579, and 580-705; for grade 4, 270-474, 475-524, 525-584, and 580-715; for grade 5, 265-474, 475-524, 525-579, and 580-725, respectively. The scores from the 3rd grade (pre-intervention) are compared to scores at the end of 4th and 5th grades.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Georgia Milestones standardized test scores in reading</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies.The tests are scored with 4 achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels for reading are 180-474, 475-524, 525-580, and 581-830; for grade 4, 210-474, 475-524, 525-573, and 574-775; for grade 5, 210-474, 475-524, 525-586, and 587-760, respectively. The scores from the 3rd grade assessment (pre-intervention) are compared to scores at the end of 4th and 5th grades.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Lexile/reading level for language arts</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Lexile Level is a popular method used by schools to measure a student reader's ability. It serves two unique functions: it is a measure of how difficult a text is, and a measurement of a student's reading ability level. A student receives his or her Lexile measure by taking a school-administered Scholastic Reading Inventory test, which is specifically designed to measure Lexile or reading ability, or by taking a standardized reading test which converts the reader's results to a Lexile measure. The normal Scholastic Guided Reading Lexile ranges for 3rd grade are 100-1120, 180-1280 for 4th grade, and 330-1280 for 5th grade.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the class grades for reading</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Class grades are calculated from the reading tests administered during the school year. The class grades for reading from 3rd grade are compared to 4th and 5th grades, and class reading grades are also compared between the students in the intervention arm and control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the class grades for math</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Class grades are calculated from the math tests administered during the school year. The class math grades from 3rd grade are compared to 4th and 5th grades, and math grades are also compared between the students in the intervention arm and control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Disciplinary Referrals</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Disciplinary referrals collected by teachers (including information regarding incident date, incident type, action taken, rule number broken, and discipline code) will be compared between grade levels and also compared between the students in the intervention arm and control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of absence</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The number of days that students were absent from school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days a student was tardy to the school</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The number of days that students were tardy to school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4968</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study arm includes the schools where the School Team (school teachers, coordinator) receives the physical activity intervention. The intervention consists of four parts:&#xD;
School Engagement and Assessment&#xD;
Training&#xD;
Physical Activity Equipment and Resources&#xD;
Ongoing Assessment and Technical Assistance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm includes the schools where the School Team does not receive any intervention but all the necessary data will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Arm</intervention_name>
    <description>The physical activity intervention consists of:&#xD;
School Engagement and Assessment - Based on the customized assessment, training is provided for school staff to develop the capacity to increase PA. A school PA team is established.&#xD;
Training - School teams are provided with ongoing in-person and virtual training to learn strategies for increasing PA before and during the school day. A training summit meeting will occur each summer, starting with the summer prior to the intervention. Teams will create a weekly calendar of activities to increase PA time to a minimum of 40 mts/day.&#xD;
PA Equipment and Resources - After training, schools are provided with PA equipment, resources and teaching aids to facilitate the integration of PA into the school day.&#xD;
Ongoing Assessment and Technical Assistance - Student accelerometer data will allow for monitoring of PA levels, so that additional technical assistance for classroom teachers can be provided if needed</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4th grade students from the elementary schools in the Gwinnett County district&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Gazmararian, PhD/MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gwinnett County Elementary Schools</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Julie A Gazmararian</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Standardized Test Score</keyword>
  <keyword>Academic Achievement</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/NCT03765047
org study id: IRB00095600
secondary id: 74281
nct id: NCT03765047
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective study to examine the impact of a school-based physical activity
      intervention on fourth and fifth grade elementary students' academic achievement, as measured
      by standardized test scores.
Serving more than 95% of US children ages 5-17, the school environment is a valuable setting
      to engage students in Physical Activity (PA) through the day, but is limited when physical
      education programs have insufficient curricular, time, financial and staffing allocations. A
      growing body of research supports the premise that interventions focused on increasing
      physical activity in schools may be more successful if supported by evidence that increased
      PA improves academic achievement, that is the clear priority for limited school time and
      resources.

      The purpose of this study is to examine the impact of a school-based physical activity
      intervention on fourth and fifth grade elementary students' academic achievement, as measured
      by standardized test scores. Baseline information about current physical activity practices
      will be collected. Schools will receive ongoing in-person and virtual training, and schools
      will be provided physical activity equipment, resources, and teaching aids. Student
      accelerometer data will allow for monitoring of physical activity levels. This study seeks to
      address gaps in the literature by studying the efficacy of a well-established intervention
      that has been shown to impact school physical activities practices, and shows promise of
      efficacy for improving student education outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in the Georgia Milestones standardized test scores in math
time frame: Up to 2 years
description: The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies. The tests are scored with four achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels of math are 290-474, 475-524, 525-579, and 580-705; for grade 4, 270-474, 475-524, 525-584, and 580-715; for grade 5, 265-474, 475-524, 525-579, and 580-725, respectively. The scores from the 3rd grade (pre-intervention) are compared to scores at the end of 4th and 5th grades.
measure: Change in the Georgia Milestones standardized test scores in reading
time frame: Up to 2 years
description: The Georgia Milestones comprehensive summative assessment is administered annually in the spring for students in grades 3 to 8. The test was first used in Spring 2015 and is the best objective universal indicator of students' academic performance in Georgia. Georgia Milestones measures how well students have learned the knowledge and skills outlined in the state-adopted content standards in English language arts, mathematics, science, and social studies.The tests are scored with 4 achievement levels. Level 1: Beginning Learner, Level 2: Developing Learner, Level 3: Proficient Learner, and Level 4: Distinguished Learner. For grade 3 the scores for the different levels for reading are 180-474, 475-524, 525-580, and 581-830; for grade 4, 210-474, 475-524, 525-573, and 574-775; for grade 5, 210-474, 475-524, 525-586, and 587-760, respectively. The scores from the 3rd grade assessment (pre-intervention) are compared to scores at the end of 4th and 5th grades.
measure: Change in the Lexile/reading level for language arts
time frame: Up to 2 years
description: Lexile Level is a popular method used by schools to measure a student reader's ability. It serves two unique functions: it is a measure of how difficult a text is, and a measurement of a student's reading ability level. A student receives his or her Lexile measure by taking a school-administered Scholastic Reading Inventory test, which is specifically designed to measure Lexile or reading ability, or by taking a standardized reading test which converts the reader's results to a Lexile measure. The normal Scholastic Guided Reading Lexile ranges for 3rd grade are 100-1120, 180-1280 for 4th grade, and 330-1280 for 5th grade.
measure: Change in the class grades for reading
time frame: Up to 2 years
description: Class grades are calculated from the reading tests administered during the school year. The class grades for reading from 3rd grade are compared to 4th and 5th grades, and class reading grades are also compared between the students in the intervention arm and control arm.
measure: Change in the class grades for math
time frame: Up to 2 years
description: Class grades are calculated from the math tests administered during the school year. The class math grades from 3rd grade are compared to 4th and 5th grades, and math grades are also compared between the students in the intervention arm and control arm.
measure: Number of Disciplinary Referrals
time frame: Up to 2 years
description: Disciplinary referrals collected by teachers (including information regarding incident date, incident type, action taken, rule number broken, and discipline code) will be compared between grade levels and also compared between the students in the intervention arm and control arm.
measure: Number of days of absence
time frame: Up to 2 years
description: The number of days that students were absent from school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.
measure: Number of days a student was tardy to the school
time frame: Up to 2 years
description: The number of days that students were tardy to school during the academic year will be collected from school records and compared between grade levels and also compared between the students in the intervention arm and control arm.
arm group label: Intervention Arm
arm group type: Experimental
description: This study arm includes the schools where the School Team (school teachers, coordinator) receives the physical activity intervention. The intervention consists of four parts:
School Engagement and Assessment
Training
Physical Activity Equipment and Resources
Ongoing Assessment and Technical Assistance
arm group label: Control Arm
arm group type: No Intervention
description: The control arm includes the schools where the School Team does not receive any intervention but all the necessary data will be collected.
intervention type: Behavioral
intervention name: Intervention Arm
description: The physical activity intervention consists of:
School Engagement and Assessment - Based on the customized assessment, training is provided for school staff to develop the capacity to increase PA. A school PA team is established.
Training - School teams are provided with ongoing in-person and virtual training to learn strategies for increasing PA before and during the school day. A training summit meeting will occur each summer, starting with the summer prior to the intervention. Teams will create a weekly calendar of activities to increase PA time to a minimum of 40 mts/day.
PA Equipment and Resources - After training, schools are provided with PA equipment, resources and teaching aids to facilitate the integration of PA into the school day.
Ongoing Assessment and Technical Assistance - Student accelerometer data will allow for monitoring of PA levels, so that additional technical assistance for classroom teachers can be provided if needed
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Julie Gazmararian, PhD/MPH
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Julie A Gazmararian
investigator title: Professor