<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/NCT02192281</url>
  </required_header>
  <id_info>
    <org_study_id>MPR-06758</org_study_id>
    <secondary_id>12-177</secondary_id>
    <nct_id>NCT02192281</nct_id>
  </id_info>
  <brief_title>Randomized Experiment of Playworks</brief_title>
  <official_title>Randomized Experiment of Playworks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mathematica Policy Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mathematica Policy Research, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Playworks has an impact on student and&#xD;
      school outcomes such as physical activity, behavior, and academic performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Playworks is a school-based program that places full-time coaches in low-income schools to&#xD;
      organize games and activities during recess. The Robert Wood Johnson Foundation (RWJF)&#xD;
      contracted with Mathematica Policy Research and its subcontractor, the John W. Gardner Center&#xD;
      for Youth and Their Communities (JGC) at Stanford University, to conduct a rigorous&#xD;
      evaluation of Playworks. Twenty-nine schools interested in implementing Playworks, across six&#xD;
      cities in the United States, were randomly assigned to treatment and control groups during&#xD;
      the 2010-2011 (cohort 1) or 2011-2012 (cohort 2) school year. Random assignment was conducted&#xD;
      within matched groups of schools within each city. In total, there were 12 blocks of matched&#xD;
      schools. For each block, one school was randomly assigned to the control group and the rest&#xD;
      to the treatment group.&#xD;
&#xD;
      During the one-year study period for each cohort, treatment schools received Playworks and&#xD;
      control schools were not eligible to implement Playworks. Data from student surveys,&#xD;
      accelerometers, and teacher surveys were collected from 4th- and 5th-grade students,&#xD;
      teachers, and school staff roughly seven months after Playworks was first implemented in&#xD;
      treatment schools.&#xD;
&#xD;
      For the student survey, students were asked to complete a 30-minute student survey in the&#xD;
      spring of their study year about their experiences at school. A team of experienced survey&#xD;
      administration staff administered the survey in the students' classrooms. In addition to the&#xD;
      student survey, teachers were asked to complete a teacher survey that asked teachers about&#xD;
      their students' experiences at school.&#xD;
&#xD;
      A subsample of students that were asked to complete the student survey also wore&#xD;
      accelerometers during one or two school days. During the accelerometer data collection&#xD;
      period, the research team arrived at participating classrooms at the beginning of the school&#xD;
      day. Team members described the function of the accelerometer and then attached one to each&#xD;
      consented student's hip, using an elastic belt. The accelerometer data was then processed&#xD;
      with the ActiLife 5 software package.&#xD;
&#xD;
      The impact of Playworks on study outcomes was estimated by comparing the average outcomes in&#xD;
      treatment and control schools using regression models customized to the unit of analysis&#xD;
      (teacher or student). The regression models used for analysis included indicators for random&#xD;
      assignment blocks to account for the blocked design and school-specific random error terms to&#xD;
      account for school-specific effects not attributable to the treatment. Covariates were also&#xD;
      included in some models to account for significant differences between treatment and control&#xD;
      groups in demographic characteristics. Models for continuous and binary outcome variables&#xD;
      were fit using least-squares estimation and logistic regression estimation, respectively.&#xD;
      Standard errors for the estimated impacts on teacher- and student-level outcomes accounted&#xD;
      for clustering at the school level using generalized estimating equations. Model-based&#xD;
      p-values and effect sizes were calculated based on the estimated impacts and corresponding&#xD;
      standard errors and multiple comparison adjustments accounted for correlations among the&#xD;
      multiple tests. Sampling weights were used when estimating impacts. The weights were&#xD;
      constructed to account for both the selection probabilities of students and teachers into the&#xD;
      sample and nonresponse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Steps Taken Per Minute During Recess</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Percentage of Accelerometer Wear Time During Recess Spent in Sedentary Activity</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Percentage of Accelerometer Wear Time During Recess Spent in Light Activity</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Percentage of Accelerometer Wear Time During Recess Spent in Moderately Intense Activity</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Percentage of Accelerometer Wear Time During Recess Spent in Vigorously Intense Activity</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Students Who Participate in Recess Activities That Make Them Sweat and Breathe Hard &quot;Sometimes&quot; or &quot;A Lot&quot;</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Teachers Who &quot;Agree&quot; or &quot;Strongly Agree&quot; That Their Students Participate in Physical Activities That Make Them Sweat and Breathe Hard During Recess</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Students Who Participated in a Sports Team After School or on the Weekend During the School Year</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Students Who Participated in Dance, Gymnastics or Martial Arts Lessons After School or on the Weekend During the School Year</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Participation in Individual Activities During Recess Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Participation in Games During Recess Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That the Following Happens &quot;Sometimes&quot; or &quot;A Lot&quot;: Adults help them play games and sports during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That the Following Happens &quot;Sometimes&quot; or &quot;A Lot&quot;: Their teacher helps them play games and sports during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That the Following Happens &quot;Sometimes&quot; or &quot;A Lot&quot;: They talk with friends during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Recess Behavior and Readiness for Class Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Recess Misbehavior/Discipline Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Ask an adult to help them solve a conflict during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Get teased about not being good at games or sports during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Get into an argument with other students during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Fight or hit other students during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Work out problems with other students during recess without fighting</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Say encouraging things to other students during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Enjoyment of Recess Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Agree &quot;A Little&quot; or &quot;A Lot&quot; That They: Like to play games and sports at recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Agree &quot;A Little&quot; or &quot;A Lot&quot; That They: Feel like they can join other kids in a game on the playground</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Agree &quot;A Little&quot; or &quot;A Lot&quot; That They: Feel left out at recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Get to play a game that they want during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Students Who Report That They Do the Following &quot;Sometimes&quot; or &quot;A Lot&quot;: Have to play a game that adults want them to play during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Games and Sports Self-Concept Scale Score</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Teachers Who &quot;Agree&quot; or &quot;Strongly Agree&quot; That Their Students: Look forward to recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Teachers Who &quot;Agree&quot; or &quot;Strongly Agree&quot; That Their Students: Enjoy adult-organized activities at recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Teachers Who &quot;Agree&quot; or &quot;Strongly Agree&quot; That Their Students: Would be upset about missing recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Teachers Who &quot;Agree&quot; or &quot;Strongly Agree&quot; That Their Students: Feel ownership over their activities during recess</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2278</enrollment>
  <condition>Focus on Physical Activity, Recess, and Play</condition>
  <arm_group>
    <arm_group_label>Playworks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Playworks was implemented during the entire school year, and outcome measures were collected in spring of the school year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Playworks was not implemented at these schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Playworks</intervention_name>
    <description>The Playworks program places full-time coaches in low-income schools to provide opportunities for organized play during recess and throughout the school day.</description>
    <arm_group_label>Playworks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students in low-income schools in urban areas&#xD;
&#xD;
          -  Students in schools where at least 50 percent of students qualify for free or&#xD;
             reduced-price lunch.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanne James-Burdumy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mathematica Policy Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martha Bleeker</last_name>
    <role>Study Director</role>
    <affiliation>Mathematica Policy Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mathematica Policy Research</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08543-2393</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Recess</keyword>
  <keyword>Accelerometer</keyword>
  <keyword>Play</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/NCT02192281
org study id: MPR-06758
secondary id: 12-177
nct id: NCT02192281
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Playworks has an impact on student and
      school outcomes such as physical activity, behavior, and academic performance.
Playworks is a school-based program that places full-time coaches in low-income schools to
      organize games and activities during recess. The Robert Wood Johnson Foundation (RWJF)
      contracted with Mathematica Policy Research and its subcontractor, the John W. Gardner Center
      for Youth and Their Communities (JGC) at Stanford University, to conduct a rigorous
      evaluation of Playworks. Twenty-nine schools interested in implementing Playworks, across six
      cities in the United States, were randomly assigned to treatment and control groups during
      the 2010-2011 (cohort 1) or 2011-2012 (cohort 2) school year. Random assignment was conducted
      within matched groups of schools within each city. In total, there were 12 blocks of matched
      schools. For each block, one school was randomly assigned to the control group and the rest
      to the treatment group.

      During the one-year study period for each cohort, treatment schools received Playworks and
      control schools were not eligible to implement Playworks. Data from student surveys,
      accelerometers, and teacher surveys were collected from 4th- and 5th-grade students,
      teachers, and school staff roughly seven months after Playworks was first implemented in
      treatment schools.

      For the student survey, students were asked to complete a 30-minute student survey in the
      spring of their study year about their experiences at school. A team of experienced survey
      administration staff administered the survey in the students' classrooms. In addition to the
      student survey, teachers were asked to complete a teacher survey that asked teachers about
      their students' experiences at school.

      A subsample of students that were asked to complete the student survey also wore
      accelerometers during one or two school days. During the accelerometer data collection
      period, the research team arrived at participating classrooms at the beginning of the school
      day. Team members described the function of the accelerometer and then attached one to each
      consented student's hip, using an elastic belt. The accelerometer data was then processed
      with the ActiLife 5 software package.

      The impact of Playworks on study outcomes was estimated by comparing the average outcomes in
      treatment and control schools using regression models customized to the unit of analysis
      (teacher or student). The regression models used for analysis included indicators for random
      assignment blocks to account for the blocked design and school-specific random error terms to
      account for school-specific effects not attributable to the treatment. Covariates were also
      included in some models to account for significant differences between treatment and control
      groups in demographic characteristics. Models for continuous and binary outcome variables
      were fit using least-squares estimation and logistic regression estimation, respectively.
      Standard errors for the estimated impacts on teacher- and student-level outcomes accounted
      for clustering at the school level using generalized estimating equations. Model-based
      p-values and effect sizes were calculated based on the estimated impacts and corresponding
      standard errors and multiple comparison adjustments accounted for correlations among the
      multiple tests. Sampling weights were used when estimating impacts. The weights were
      constructed to account for both the selection probabilities of students and teachers into the
      sample and nonresponse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Mean Number of Accelerometer Intensity Counts Recorded Per Minute During Recess
time frame: 8 weeks
measure: Mean Number of Steps Taken Per Minute During Recess
time frame: 8 weeks
measure: Mean Percentage of Accelerometer Wear Time During Recess Spent in Sedentary Activity
time frame: 8 weeks
measure: Mean Percentage of Accelerometer Wear Time During Recess Spent in Light Activity
time frame: 8 weeks
measure: Mean Percentage of Accelerometer Wear Time During Recess Spent in Moderately Intense Activity
time frame: 8 weeks
measure: Mean Percentage of Accelerometer Wear Time During Recess Spent in Vigorously Intense Activity
time frame: 8 weeks
measure: Percentage of Students Who Participate in Recess Activities That Make Them Sweat and Breathe Hard "Sometimes" or "A Lot"
time frame: 8 weeks
measure: Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students Participate in Physical Activities That Make Them Sweat and Breathe Hard During Recess
time frame: 8 weeks
measure: Percentage of Students Who Participated in a Sports Team After School or on the Weekend During the School Year
time frame: 8 weeks
measure: Percentage of Students Who Participated in Dance, Gymnastics or Martial Arts Lessons After School or on the Weekend During the School Year
time frame: 8 weeks
measure: Participation in Individual Activities During Recess Scale Score
time frame: 8 weeks
measure: Participation in Games During Recess Scale Score
time frame: 8 weeks
measure: Percentage of Students Who Report That the Following Happens "Sometimes" or "A Lot": Adults help them play games and sports during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That the Following Happens "Sometimes" or "A Lot": Their teacher helps them play games and sports during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That the Following Happens "Sometimes" or "A Lot": They talk with friends during recess
time frame: 8 weeks
measure: Recess Behavior and Readiness for Class Scale Score
time frame: 8 weeks
measure: Recess Misbehavior/Discipline Scale Score
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Ask an adult to help them solve a conflict during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Get teased about not being good at games or sports during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Get into an argument with other students during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Fight or hit other students during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Work out problems with other students during recess without fighting
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Say encouraging things to other students during recess
time frame: 8 weeks
measure: Enjoyment of Recess Scale Score
time frame: 8 weeks
measure: Percentage of Students Who Agree "A Little" or "A Lot" That They: Like to play games and sports at recess
time frame: 8 weeks
measure: Percentage of Students Who Agree "A Little" or "A Lot" That They: Feel like they can join other kids in a game on the playground
time frame: 8 weeks
measure: Percentage of Students Who Agree "A Little" or "A Lot" That They: Feel left out at recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Get to play a game that they want during recess
time frame: 8 weeks
measure: Percentage of Students Who Report That They Do the Following "Sometimes" or "A Lot": Have to play a game that adults want them to play during recess
time frame: 8 weeks
measure: Games and Sports Self-Concept Scale Score
time frame: 8 weeks
measure: Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students: Look forward to recess
time frame: 8 weeks
measure: Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students: Enjoy adult-organized activities at recess
time frame: 8 weeks
measure: Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students: Would be upset about missing recess
time frame: 8 weeks
measure: Percentage of Teachers Who "Agree" or "Strongly Agree" That Their Students: Feel ownership over their activities during recess
time frame: 8 weeks
arm group label: Playworks
arm group type: Experimental
description: Playworks was implemented during the entire school year, and outcome measures were collected in spring of the school year.
arm group label: Control
arm group type: No Intervention
description: Playworks was not implemented at these schools.
intervention type: Other
intervention name: Playworks
description: The Playworks program places full-time coaches in low-income schools to provide opportunities for organized play during recess and throughout the school day.
arm group label: Playworks
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susanne James-Burdumy
role: Principal Investigator
affiliation: Mathematica Policy Research
last name: Martha Bleeker
role: Study Director
affiliation: Mathematica Policy Research
facility: 
country: United States
responsible party type: Sponsor