<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/NCT03283904</url>
  </required_header>
  <id_info>
    <org_study_id>KIDSMOVE</org_study_id>
    <nct_id>NCT03283904</nct_id>
  </id_info>
  <brief_title>Active Schools: Skelmersdale</brief_title>
  <acronym>AS:Sk</acronym>
  <official_title>Active Schools: Skelmersdale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edge Hill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Lancashire Sport Partnership</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Lancashire Leisure Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Edge Hill University</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 AS:Sk is to improve physical activity levels and health-related outcomes of&#xD;
      children from the Skelmersdale area of West Lancashire through a school-based physical&#xD;
      activity multi-component intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multi-component intervention is the third and final phase of the AS:Sk project. It will&#xD;
      be implemented and evaluated in four of the seven participating schools. The remaining three&#xD;
      schools will act as controls and will not implement any physical activity intervention during&#xD;
      the period of the research project. Schools will be randomly assigned to either intervention&#xD;
      or control conditions. The multi-component intervention will involve multiple areas of the&#xD;
      schools' curricula, environments, or policies being targeted. Decisions regarding these&#xD;
      intervention components will be influenced by what was deemed effective, and feasible within&#xD;
      phase 2 of the project. Phase 2 included a four week trial of three different single&#xD;
      component physical activity interventions across all participating schools. Phase 3 will be&#xD;
      implemented for at least eight weeks and if successful, it would then be rolled out in the&#xD;
      control schools at the end of the project. Participants from both intervention and control&#xD;
      schools will take part in the measures for evaluation in this third and final phase of the&#xD;
      project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>
    <intervention_model_description>Control vs Intervention clusters of schools</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>School-day moderate-to-vigorous physical activity (MVPA)</measure>
    <time_frame>7 days</time_frame>
    <description>Minutes of school-day MVPA accrued</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Physical Activity</condition>
  <condition>Sedentary Lifestyle</condition>
  <arm_group>
    <arm_group_label>Multicomponent PA intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multicomponent physical activity intervention</intervention_name>
    <description>School-based multicomponent intervention</description>
    <arm_group_label>Multicomponent PA intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Year 5 pupil attending participating schools&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart J Fairclough</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edge Hill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Edge Hill University</name>
      <address>
        <city>Ormskirk</city>
        <state>Lancs</state>
        <zip>L39 4QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.</citation>
    <PMID>28509887</PMID>
  </results_reference>
  <results_reference>
    <citation>Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.</citation>
    <PMID>28486972</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Schools</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/NCT03283904
org study id: KIDSMOVE
nct id: NCT03283904
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of AS:Sk is to improve physical activity levels and health-related outcomes of
      children from the Skelmersdale area of West Lancashire through a school-based physical
      activity multi-component intervention.
The multi-component intervention is the third and final phase of the AS:Sk project. It will
      be implemented and evaluated in four of the seven participating schools. The remaining three
      schools will act as controls and will not implement any physical activity intervention during
      the period of the research project. Schools will be randomly assigned to either intervention
      or control conditions. The multi-component intervention will involve multiple areas of the
      schools' curricula, environments, or policies being targeted. Decisions regarding these
      intervention components will be influenced by what was deemed effective, and feasible within
      phase 2 of the project. Phase 2 included a four week trial of three different single
      component physical activity interventions across all participating schools. Phase 3 will be
      implemented for at least eight weeks and if successful, it would then be rolled out in the
      control schools at the end of the project. Participants from both intervention and control
      schools will take part in the measures for evaluation in this third and final phase of the
      project.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Control vs Intervention clusters of schools
primary purpose: Prevention
masking: None (Open Label)
measure: School-day moderate-to-vigorous physical activity (MVPA)
time frame: 7 days
description: Minutes of school-day MVPA accrued
arm group label: Multicomponent PA intervention
arm group type: Experimental
description: Intervention schools will adopt a multicomponent intervention by integrating physical activities into different parts of the school day
intervention type: Other
intervention name: Multicomponent physical activity intervention
description: School-based multicomponent intervention
arm group label: Multicomponent PA intervention
criteria: 
gender: All
minimum age: 9 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stuart J Fairclough
role: Principal Investigator
affiliation: Edge Hill University
facility: 
country: United Kingdom
citation: Taylor SL, Curry WB, Knowles ZR, Noonan RJ, McGrane B, Fairclough SJ. Predictors of Segmented School Day Physical Activity and Sedentary Time in Children from a Northwest England Low-Income Community. Int J Environ Res Public Health. 2017 May 16;14(5):534. doi: 10.3390/ijerph14050534.
PMID: 28509887
citation: Fairclough SJ, Dumuid D, Taylor S, Curry W, McGrane B, Stratton G, Maher C, Olds T. Fitness, fatness and the reallocation of time between children's daily movement behaviours: an analysis of compositional data. Int J Behav Nutr Phys Act. 2017 May 10;14(1):64. doi: 10.1186/s12966-017-0521-z.
PMID: 28486972
responsible party type: Sponsor