<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/NCT03279926</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000628</org_study_id>
    <secondary_id>1R21CA218592-01</secondary_id>
    <nct_id>NCT03279926</nct_id>
  </id_info>
  <brief_title>Preschoolers Learning and Active in PlaY</brief_title>
  <acronym>PLAY</acronym>
  <official_title>Preschoolers Learning and Active in PlaY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's 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>
      The overall aim of this proposal is to develop and test early childhood education&#xD;
      setting-based physical activity (PA) interventions that are innovative by using wearable&#xD;
      technology to facilitate monitoring, feedback and motivation for physical activity across&#xD;
      multiple levels (child, parent, educator). We posit that our intervention strategies will&#xD;
      promote behavior changes in parents and educators, leading to greater awareness and&#xD;
      communication about physical activity, more active play opportunities, and ultimately more&#xD;
      physical activity for preschoolers. In the R21, we will test the acceptability, feasibility&#xD;
      and initial efficacy of three 6 month early childhood education setting- based, multi-level&#xD;
      interventions to promote preschoolers' PA using wearable technology and additional behavior&#xD;
      change techniques to engage educators and parents. The results of this study will inform a&#xD;
      larger intervention trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-intervention physical activity (children)</measure>
    <time_frame>Month 6 compared to baseline</time_frame>
    <description>accelerometer measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-intervention physical activity (children)</measure>
    <time_frame>Month 1 compared to baseline</time_frame>
    <description>accelerometer measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active play opportunities at child care</measure>
    <time_frame>Month 6 compared to baseline</time_frame>
    <description>Using an observation tool, a trained research assistant will note opportunities for active play (including teacher led, child-initiated, outdoor and indoor)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>activity tracker wear</measure>
    <time_frame>Month 1</time_frame>
    <description>amount of days activity tracker is worn by participant</description>
  </other_outcome>
  <other_outcome>
    <measure>activity tracker wear</measure>
    <time_frame>Month 6</time_frame>
    <description>amount of days the activity tracker is worn by participant</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>PLAY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preschoolers &amp; their teachers will get activity trackers and the child care program/providers will get some basic information on the use of the trackers and how to integrate their use in the curriculum. A PLAY Champion will be identified to help support PLAY related activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLAY Parents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Everything in Arm 1 plus one parent per child will receive an activity tracker and will get reports to help with physical activity goal setting for the family.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLAY Teachers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Everything in Arm 1 plus an enhanced focus on teacher wellness, specifically with regard to active lifestyles for them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PLAY</intervention_name>
    <description>Activity trackers + curriculum information</description>
    <arm_group_label>PLAY</arm_group_label>
    <arm_group_label>PLAY Parents</arm_group_label>
    <arm_group_label>PLAY Teachers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PLAY Parents</intervention_name>
    <description>Enhanced parental engagement</description>
    <arm_group_label>PLAY Parents</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PLAY Teachers</intervention_name>
    <description>Enhanced teacher engagement with active living initiates for the teachers</description>
    <arm_group_label>PLAY Teachers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  attends preschool in a child care center participating in this study&#xD;
&#xD;
          -  no physical/health restrictions on participating in physical activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to participate in all physical activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pooja Tandon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 4, 2020</last_update_submitted>
  <last_update_submitted_qc>September 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Pooja Tandon</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03279926
org study id: STUDY00000628
secondary id: 1R21CA218592-01
nct id: NCT03279926
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall aim of this proposal is to develop and test early childhood education
      setting-based physical activity (PA) interventions that are innovative by using wearable
      technology to facilitate monitoring, feedback and motivation for physical activity across
      multiple levels (child, parent, educator). We posit that our intervention strategies will
      promote behavior changes in parents and educators, leading to greater awareness and
      communication about physical activity, more active play opportunities, and ultimately more
      physical activity for preschoolers. In the R21, we will test the acceptability, feasibility
      and initial efficacy of three 6 month early childhood education setting- based, multi-level
      interventions to promote preschoolers' PA using wearable technology and additional behavior
      change techniques to engage educators and parents. The results of this study will inform a
      larger intervention trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Post-intervention physical activity (children)
time frame: Month 6 compared to baseline
description: accelerometer measured
measure: Post-intervention physical activity (children)
time frame: Month 1 compared to baseline
description: accelerometer measured
measure: Active play opportunities at child care
time frame: Month 6 compared to baseline
description: Using an observation tool, a trained research assistant will note opportunities for active play (including teacher led, child-initiated, outdoor and indoor)
measure: activity tracker wear
time frame: Month 1
description: amount of days activity tracker is worn by participant
measure: activity tracker wear
time frame: Month 6
description: amount of days the activity tracker is worn by participant
arm group label: PLAY
arm group type: Experimental
description: Preschoolers & their teachers will get activity trackers and the child care program/providers will get some basic information on the use of the trackers and how to integrate their use in the curriculum. A PLAY Champion will be identified to help support PLAY related activities.
arm group label: PLAY Parents
arm group type: Experimental
description: Everything in Arm 1 plus one parent per child will receive an activity tracker and will get reports to help with physical activity goal setting for the family.
arm group label: PLAY Teachers
arm group type: Experimental
description: Everything in Arm 1 plus an enhanced focus on teacher wellness, specifically with regard to active lifestyles for them.
intervention type: Behavioral
intervention name: PLAY
description: Activity trackers + curriculum information
arm group label: PLAY
arm group label: PLAY Parents
arm group label: PLAY Teachers
intervention type: Behavioral
intervention name: PLAY Parents
description: Enhanced parental engagement
arm group label: PLAY Parents
intervention type: Behavioral
intervention name: PLAY Teachers
description: Enhanced teacher engagement with active living initiates for the teachers
arm group label: PLAY Teachers
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pooja Tandon, MD
role: Principal Investigator
affiliation: Seattle Children's
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Pooja Tandon
investigator title: Assistant Professor