<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/NCT03752008</url>
  </required_header>
  <id_info>
    <org_study_id>14169</org_study_id>
    <nct_id>NCT03752008</nct_id>
  </id_info>
  <brief_title>Preschoolers Active at Child Care (PACT)</brief_title>
  <acronym>PACT</acronym>
  <official_title>Preschoolers Active at Child Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</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 aim of this study was to develop, test, and compare two approaches to increasing physical&#xD;
      activity (PA) and decreasing sedentary time among young children at child care centers, one&#xD;
      which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing&#xD;
      outdoor free play time (OP=Outdoor Play!).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a matched pair cluster-randomized study in 10 child care centers. One classroom in&#xD;
      each pair received either AP or OP, and their providers received a condition-specific 3-hour&#xD;
      workshop. Pre- and post-intervention data were collected from classroom observation and&#xD;
      accelerometers. Additional information about teachers' attitudes and practices was collected&#xD;
      via pre-intervention survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2012</start_date>
  <completion_date type="Actual">April 24, 2014</completion_date>
  <primary_completion_date type="Actual">April 24, 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>
    <intervention_model_description>10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre to post change in preschoolers Physical Activity</measure>
    <time_frame>baseline and 12 weeks after intervention</time_frame>
    <description>Physical Activity levels measured by actigraphy monitors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre to post change in Physical Activity Opportunities</measure>
    <time_frame>baseline and 12 weeks after intervention</time_frame>
    <description>Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities. Total minutes in each category were calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pre to post Teacher Physical Activity</measure>
    <time_frame>baseline and 12 weeks after intervention</time_frame>
    <description>Physical Activity levels measured by actigraphy monitors</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Active Play (AP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm received the Active Play curriculum intervention (described in following section).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outdoor Play (OP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm received the Outdoor Play curriculum intervention (described in following section).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Play (AP)</intervention_name>
    <description>This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.</description>
    <arm_group_label>Active Play (AP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Outdoor Play (OP)</intervention_name>
    <description>This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.</description>
    <arm_group_label>Outdoor Play (OP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Teachers/Staff&#xD;
&#xD;
          -  be a teacher/staff member in a participating childcare center&#xD;
&#xD;
          -  Students&#xD;
&#xD;
          -  be 3 - 5 years old&#xD;
&#xD;
          -  be a full day student in the classroom where data collection was occurring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pooja Tandon, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Chidlren's</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</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>
  <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/NCT03752008
org study id: 14169
nct id: NCT03752008
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to develop, test, and compare two approaches to increasing physical
      activity (PA) and decreasing sedentary time among young children at child care centers, one
      which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing
      outdoor free play time (OP=Outdoor Play!).
This was a matched pair cluster-randomized study in 10 child care centers. One classroom in
      each pair received either AP or OP, and their providers received a condition-specific 3-hour
      workshop. Pre- and post-intervention data were collected from classroom observation and
      accelerometers. Additional information about teachers' attitudes and practices was collected
      via pre-intervention survey.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.
primary purpose: Other
masking: None (Open Label)
measure: Pre to post change in preschoolers Physical Activity
time frame: baseline and 12 weeks after intervention
description: Physical Activity levels measured by actigraphy monitors
measure: Pre to post change in Physical Activity Opportunities
time frame: baseline and 12 weeks after intervention
description: Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities. Total minutes in each category were calculated.
measure: pre to post Teacher Physical Activity
time frame: baseline and 12 weeks after intervention
description: Physical Activity levels measured by actigraphy monitors
arm group label: Active Play (AP)
arm group type: Experimental
description: This arm received the Active Play curriculum intervention (described in following section).
arm group label: Outdoor Play (OP)
arm group type: Experimental
description: This arm received the Outdoor Play curriculum intervention (described in following section).
intervention type: Behavioral
intervention name: Active Play (AP)
description: This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.
arm group label: Active Play (AP)
intervention type: Behavioral
intervention name: Outdoor Play (OP)
description: This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.
arm group label: Outdoor Play (OP)
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pooja Tandon, MD MPH
role: Principal Investigator
affiliation: Seattle Chidlren's
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Pooja Tandon
investigator title: Assistant Professor
sharing ipd: No