<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/NCT03256188</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00117049</org_study_id>
    <nct_id>NCT03256188</nct_id>
  </id_info>
  <brief_title>Interrupting Prolonged Sitting With Activity</brief_title>
  <acronym>InPACT</acronym>
  <official_title>Interrupting Prolonged Sitting With Activity Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</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 tested the feasibility of interrupting prolonged sitting with 10, 3-minute&#xD;
      activity breaks in elementary school classrooms. Three elementary schools in Southeast&#xD;
      Michigan (20 teachers, 500 students) participated in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      School environments have historically provided many opportunities for children to be&#xD;
      physically active through comprehensive programs, including recess, intramural physical&#xD;
      activity clubs, interscholastic sports and physical education. However, with recent cuts to&#xD;
      public school funding and an increased emphasis on standardized test scores, schools&#xD;
      districts across the country have reduced time allocated for structured physical activity in&#xD;
      favor of additional academic instruction time. This is troubling as uninterrupted prolonged&#xD;
      sitting time is associated with increased disruptive behavior, lower academic achievement and&#xD;
      increased obesity risk in children. As such, developing low-cost, innovative physical&#xD;
      activity interventions aimed at improving weight outcomes and cognitive function in children&#xD;
      are warranted.&#xD;
&#xD;
      Researchers have targeted the school classroom, where students spend the majority of their&#xD;
      time, as a potential intervention site. Classroom-based physical activity interventions have&#xD;
      been largely successful at increasing physical activity, improving physical fitness and&#xD;
      academic achievement among children. Yet, no intervention to date has been able to produce&#xD;
      significant improvements in weight status, in part due to the intensity, duration and&#xD;
      frequency of activities employed (i.e., low-to-moderate intensity; 10-30 minutes per session;&#xD;
      1-2 sessions per day). Preliminary evidence from our laboratory suggests intermittent&#xD;
      activity breaks performed at a moderate-to-vigorous intensity elicits greater total daily&#xD;
      physical activity energy expenditure without subsequent increases in food intake compared to&#xD;
      lower intensity activities. Other researchers have confirmed greater reductions in weight and&#xD;
      fat mass in response to higher rather than lower intensity physical activities. In addition,&#xD;
      short bursts of activity rather than continuous movements more closely mimics children's&#xD;
      natural activity patterns in free-living environments. Hence, incorporating intermittent&#xD;
      activity breaks of moderate-to-vigorous intensity as an intervention component may increase&#xD;
      the likelihood of classroom-based physical activity interventions improving weight outcomes&#xD;
      in children.&#xD;
&#xD;
      Implementing intermittent activity breaks in a classroom will require adjustments to both&#xD;
      teaching curricula and classroom design. Current teaching curricula promotes sedentary&#xD;
      behaviors by requiring children to spend between 6 and 8 hours in seated academic instruction&#xD;
      per day. Moreover, current classroom designs (i.e., size of the classroom and interior areas,&#xD;
      type of furniture, flooring and room arrangement) optimize student learning and classroom&#xD;
      management with little consideration given to physical activity and movement. Yet, simple&#xD;
      adjustments to teaching curricula (i.e. coupling physical activity with teacher's existing&#xD;
      lessons) and classroom design (e.g. using smart floor planning to restructure spaces in a&#xD;
      classroom) can dramatically increase movement and subsequent learning within that space. In&#xD;
      partnership with the School of Education and the Taubman College of Architecture &amp; Urban&#xD;
      Planning, two traditionally non-health related fields, the overall objectives of this pilot&#xD;
      study are to: 1) develop a classroom curriculum and floor plan that promotes movement,&#xD;
      learning and positive behavioral outcomes; and 2) test the feasibility of implementing our&#xD;
      classroom-based physical activity intervention (Interrupting Prolonged sitting with ACTivity&#xD;
      or INPACT) in three elementary schools (20 classrooms) across the state of Michigan. Third&#xD;
      thru fifth grade teachers and students from Columbia Elementary, Estabrook Elementary and&#xD;
      Anderson Elementary will be recruited to participate in this pilot study with classroom&#xD;
      teachers delivering the physical activity intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate-to-vigorous physical activity (student)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess student physical activity intensity and physical activity minutes completed in the classroom.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Moderate-to-vigorous physical activity (teacher)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess teacher physical activity intensity and physical activity minutes completed in the classroom.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transition time</measure>
    <time_frame>16 weeks</time_frame>
    <description>Transition time was assessed via direct observation and was calculated as the amount of time from when the teacher completed instructions to his/her class to prepare for an activity break to when students started engaging in the activity break.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-on-task</measure>
    <time_frame>16 weeks</time_frame>
    <description>Time-on-task was assessed via direct observation and was calculated as the percent of students following the directions of the teacher 30 seconds post activity break.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity enjoyment</measure>
    <time_frame>16 weeks</time_frame>
    <description>Teachers distributed the revised Physical Activity Enjoyment Scale (PACES) to their students to assess enjoyment of participating in the activity breaks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity confidence</measure>
    <time_frame>16 weeks</time_frame>
    <description>Teachers distributed a single-item question from the Physical Activity Self-Efficacy Scale (PASES) to measure physical activity confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity heart rate</measure>
    <time_frame>16 weeks</time_frame>
    <description>Heart rate during physical activity breaks in the classroom was assessed via heart rate monitoring.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Active classroom</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty elementary school teachers implemented 10, 3-minute moderate-to-vigorous physical activity breaks (50-75% of heart rate maximum), 5 days per week in their classrooms over a 16-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active classroom</intervention_name>
    <description>30 minutes of moderate-to-vigorous physical activity</description>
    <arm_group_label>Active classroom</arm_group_label>
    <other_name>InPACT classroom</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3rd thru 6th grade students in participating InPACT classrooms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca E Hasson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Childhood Disparities Research Laboratory</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Rebecca Hasson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>classroom</keyword>
  <keyword>prolonged sitting</keyword>
  <keyword>sedentary time</keyword>
  <keyword>time-on-task</keyword>
  <keyword>children</keyword>
  <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/NCT03256188
org study id: HUM00117049
nct id: NCT03256188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tested the feasibility of interrupting prolonged sitting with 10, 3-minute
      activity breaks in elementary school classrooms. Three elementary schools in Southeast
      Michigan (20 teachers, 500 students) participated in this study.
School environments have historically provided many opportunities for children to be
      physically active through comprehensive programs, including recess, intramural physical
      activity clubs, interscholastic sports and physical education. However, with recent cuts to
      public school funding and an increased emphasis on standardized test scores, schools
      districts across the country have reduced time allocated for structured physical activity in
      favor of additional academic instruction time. This is troubling as uninterrupted prolonged
      sitting time is associated with increased disruptive behavior, lower academic achievement and
      increased obesity risk in children. As such, developing low-cost, innovative physical
      activity interventions aimed at improving weight outcomes and cognitive function in children
      are warranted.

      Researchers have targeted the school classroom, where students spend the majority of their
      time, as a potential intervention site. Classroom-based physical activity interventions have
      been largely successful at increasing physical activity, improving physical fitness and
      academic achievement among children. Yet, no intervention to date has been able to produce
      significant improvements in weight status, in part due to the intensity, duration and
      frequency of activities employed (i.e., low-to-moderate intensity; 10-30 minutes per session;
      1-2 sessions per day). Preliminary evidence from our laboratory suggests intermittent
      activity breaks performed at a moderate-to-vigorous intensity elicits greater total daily
      physical activity energy expenditure without subsequent increases in food intake compared to
      lower intensity activities. Other researchers have confirmed greater reductions in weight and
      fat mass in response to higher rather than lower intensity physical activities. In addition,
      short bursts of activity rather than continuous movements more closely mimics children's
      natural activity patterns in free-living environments. Hence, incorporating intermittent
      activity breaks of moderate-to-vigorous intensity as an intervention component may increase
      the likelihood of classroom-based physical activity interventions improving weight outcomes
      in children.

      Implementing intermittent activity breaks in a classroom will require adjustments to both
      teaching curricula and classroom design. Current teaching curricula promotes sedentary
      behaviors by requiring children to spend between 6 and 8 hours in seated academic instruction
      per day. Moreover, current classroom designs (i.e., size of the classroom and interior areas,
      type of furniture, flooring and room arrangement) optimize student learning and classroom
      management with little consideration given to physical activity and movement. Yet, simple
      adjustments to teaching curricula (i.e. coupling physical activity with teacher's existing
      lessons) and classroom design (e.g. using smart floor planning to restructure spaces in a
      classroom) can dramatically increase movement and subsequent learning within that space. In
      partnership with the School of Education and the Taubman College of Architecture & Urban
      Planning, two traditionally non-health related fields, the overall objectives of this pilot
      study are to: 1) develop a classroom curriculum and floor plan that promotes movement,
      learning and positive behavioral outcomes; and 2) test the feasibility of implementing our
      classroom-based physical activity intervention (Interrupting Prolonged sitting with ACTivity
      or INPACT) in three elementary schools (20 classrooms) across the state of Michigan. Third
      thru fifth grade teachers and students from Columbia Elementary, Estabrook Elementary and
      Anderson Elementary will be recruited to participate in this pilot study with classroom
      teachers delivering the physical activity intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Moderate-to-vigorous physical activity (student)
time frame: 16 weeks
description: Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess student physical activity intensity and physical activity minutes completed in the classroom.
measure: Moderate-to-vigorous physical activity (teacher)
time frame: 16 weeks
description: Direct observation via the System for Observing Play and Leisure Activity in Youth (SOPLAY) was used to assess teacher physical activity intensity and physical activity minutes completed in the classroom.
measure: Transition time
time frame: 16 weeks
description: Transition time was assessed via direct observation and was calculated as the amount of time from when the teacher completed instructions to his/her class to prepare for an activity break to when students started engaging in the activity break.
measure: Time-on-task
time frame: 16 weeks
description: Time-on-task was assessed via direct observation and was calculated as the percent of students following the directions of the teacher 30 seconds post activity break.
measure: Physical activity enjoyment
time frame: 16 weeks
description: Teachers distributed the revised Physical Activity Enjoyment Scale (PACES) to their students to assess enjoyment of participating in the activity breaks.
measure: Physical activity confidence
time frame: 16 weeks
description: Teachers distributed a single-item question from the Physical Activity Self-Efficacy Scale (PASES) to measure physical activity confidence.
measure: Physical activity heart rate
time frame: 16 weeks
description: Heart rate during physical activity breaks in the classroom was assessed via heart rate monitoring.
arm group label: Active classroom
arm group type: Experimental
description: Twenty elementary school teachers implemented 10, 3-minute moderate-to-vigorous physical activity breaks (50-75% of heart rate maximum), 5 days per week in their classrooms over a 16-week period.
intervention type: Behavioral
intervention name: Active classroom
description: 30 minutes of moderate-to-vigorous physical activity
arm group label: Active classroom
other name: InPACT classroom
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca E Hasson, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Rebecca Hasson
investigator title: Assistant Professor
sharing ipd: No