<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/NCT03805295</url>
  </required_header>
  <id_info>
    <org_study_id>2017P002770</org_study_id>
    <nct_id>NCT03805295</nct_id>
  </id_info>
  <brief_title>Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA</brief_title>
  <official_title>Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Council on Exercise</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BOKS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere,&#xD;
      MA, and its effect on participating students with regard to BMI, cognitive, and quality of&#xD;
      life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program&#xD;
      that has been implemented in over 2,000 elementary and middle schools. Two sessions will be&#xD;
      held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program&#xD;
      participation on child BMI, quality of life, and executive function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Mass Index (kg/m^2)</measure>
    <time_frame>Baseline, Follow-up for each session (12 weeks)</time_frame>
    <description>calculated from height and weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Executive Function</measure>
    <time_frame>Baseline, Follow-up for each session (12 weeks)</time_frame>
    <description>Executive function and attention/concentration as measured by the Flanker Task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life PedsQL</measure>
    <time_frame>Baseline, Follow-up for each session (12 weeks)</time_frame>
    <description>Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Physical Activity</condition>
  <condition>Quality of Life</condition>
  <condition>Fitness</condition>
  <condition>Executive Function</condition>
  <arm_group>
    <arm_group_label>Spring 2018 Participation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fall 2018 Participation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BOKS Program</intervention_name>
    <description>12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.</description>
    <arm_group_label>Fall 2018 Participation</arm_group_label>
    <arm_group_label>Spring 2018 Participation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the BOKS program&#xD;
&#xD;
          -  Participating school&#xD;
&#xD;
          -  Age 5-14&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No valid consent&#xD;
&#xD;
          -  Not enrolled in BOKS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elsie Taveras, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elsie Taveras, MD</investigator_full_name>
    <investigator_title>Chief, Division of General Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <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/NCT03805295
org study id: 2017P002770
nct id: NCT03805295
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere,
      MA, and its effect on participating students with regard to BMI, cognitive, and quality of
      life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program
      that has been implemented in over 2,000 elementary and middle schools. Two sessions will be
      held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program
      participation on child BMI, quality of life, and executive function.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Body Mass Index (kg/m^2)
time frame: Baseline, Follow-up for each session (12 weeks)
description: calculated from height and weight
measure: Change in Executive Function
time frame: Baseline, Follow-up for each session (12 weeks)
description: Executive function and attention/concentration as measured by the Flanker Task
measure: Change in Quality of life PedsQL
time frame: Baseline, Follow-up for each session (12 weeks)
description: Measured by PedsQL, a validated measure of pediatric self-rated quality of life with higher score indicating higher quality of life.
arm group label: Spring 2018 Participation
arm group type: Experimental
description: Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018.
arm group label: Fall 2018 Participation
arm group type: Experimental
description: Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018.
intervention type: Other
intervention name: BOKS Program
description: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
arm group label: Fall 2018 Participation
arm group label: Spring 2018 Participation
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elsie Taveras, MD
role: Principal Investigator
affiliation: MGH
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elsie Taveras, MD
investigator title: Chief, Division of General Pediatrics
mesh term: Overweight
sharing ipd: No