<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/NCT03236363</url>
  </required_header>
  <id_info>
    <org_study_id>PI16b/01919</org_study_id>
    <nct_id>NCT03236363</nct_id>
  </id_info>
  <brief_title>Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!</brief_title>
  <acronym>MOVI-da10!</acronym>
  <official_title>Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carlos III Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Castilla-La Mancha</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Project which objective is to test the effectiveness of a classroom-based physical activity&#xD;
      intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and&#xD;
      executive function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last decade, this research group has tested the effectiveness of three interventions&#xD;
      following after-school intervention model. The first one (MOVI) was carried out in&#xD;
      peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a&#xD;
      moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement&#xD;
      of the lipid profile, without significantly improving the global cardiometabolic risk because&#xD;
      it did not produce a reduction in insulinemia.&#xD;
&#xD;
      The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased&#xD;
      the duration and intensity of the sessions, and was focused on the development of muscular&#xD;
      strength in order to improve insulinemia levels. The intervention showed proved&#xD;
      effectiveness; in addition, the data from this intervention showed a modest improvement in&#xD;
      girls' aerobic capacity, but not in boys.&#xD;
&#xD;
      The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses&#xD;
      that vigorous physical activity at early ages could produce lifelong cardio-metabolic&#xD;
      benefits. Data submitted for publication in this study show that, as in the case of the&#xD;
      IDEFICS study in children of similar age, the intervention was not effective in improving&#xD;
      fitness.&#xD;
&#xD;
      This new edition (MOVI-da10!) has been designed following integrated physical activity&#xD;
      intervention and active breaks designs, and as a controlled cluster-randomized trial&#xD;
      including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two&#xD;
      intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third&#xD;
      grade preschool children (about 5 years old), using two different design. Three of them will&#xD;
      receive an active breaks intervention, in which twice a day a 10 minutes breaks standard&#xD;
      physical activity will be developed, and the other three will receive twice a day a 10&#xD;
      minutes of enriched physical activity integrated in the curriculum. The other three schools&#xD;
      will be allocated to the control group (CG).&#xD;
&#xD;
      During an academic year the MOVIda10! interventions will consist of: i) an integrated across&#xD;
      the curriculum cognitive demanding physical activity program including two active breaks&#xD;
      lasting 10 min, five days/week; and ii) an active breaks physical activity program including&#xD;
      two active breaks lasting 10 min, five days/week. In the CG regular physical activity will&#xD;
      continue.&#xD;
&#xD;
      At the end of the school year the researchers will determine main outcome variables: changes&#xD;
      in VO2max, body fat by bioimpedance and executive function.&#xD;
&#xD;
      The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on&#xD;
      physical activity integrated in the curriculum for third grade preschool children, will be:&#xD;
&#xD;
        1. Moderately increase the executive function and academic performance in the IGs versus&#xD;
           the CG (effect size 0.5).&#xD;
&#xD;
        2. Increase aerobic capacity (VO2max) in IGs versus CG by 3%.&#xD;
&#xD;
        3. Reduced body fat in IGs versus CG by 3%&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Executive function</measure>
    <time_frame>One year</time_frame>
    <description>Executive function will be measured by standardized test using the NIH toolbox</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VO2 max</measure>
    <time_frame>One year</time_frame>
    <description>It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor skills</measure>
    <time_frame>One year</time_frame>
    <description>By using the Movement Assessment Battery for Children 2 (M-ABC 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat%</measure>
    <time_frame>One year</time_frame>
    <description>Body fat percentage measured by Bioimpedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>One year</time_frame>
    <description>By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Physical Activity</condition>
  <condition>Children</condition>
  <condition>Obesity</condition>
  <condition>Cardiovascular</condition>
  <condition>Cardiorespiratory Fitness</condition>
  <arm_group>
    <arm_group_label>MOVI-da 10! active breaks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOVI-da10! integrated physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate &lt;150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOVI-da10! active breaks</intervention_name>
    <description>MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children</description>
    <arm_group_label>MOVI-da 10! active breaks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOVI-da10! integrated physical activity</intervention_name>
    <description>MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate &lt;150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children</description>
    <arm_group_label>MOVI-da10! integrated physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schools must have at least one full classrooms for the 3rd year of preschool.&#xD;
&#xD;
          -  The approval of boards of governors will be necessary to participate in the&#xD;
             intervention and in the measurements at the beginning and end of academic year.&#xD;
&#xD;
          -  Children's parents or legal representatives will sign an informed consent to&#xD;
             participate.&#xD;
&#xD;
          -  Children's parents will be invited to collaborate by filling in questionnaires with&#xD;
             regard to family leisure habits, sleeping, eating and getting around town.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with severe Spanish language learning difficulties.&#xD;
&#xD;
          -  Children with serious physical or mental disorders identified by parents or teachers&#xD;
             that would impede participation in the programme's activities&#xD;
&#xD;
          -  Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma,&#xD;
             which in the opinion of their paediatricians would prevent their participation in the&#xD;
             programme's activities (MOVI-da10!).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vicente Martinez-Vizcaino, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Social and Health Care Research Center, University of Castilla-La Mancha</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Social and Health Research Center. Universidad de Castilla-La Mancha</name>
      <address>
        <city>Cuenca</city>
        <zip>16071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Obesity</keyword>
  <keyword>Children</keyword>
  <keyword>Cognitive function</keyword>
  <keyword>Academic achievement</keyword>
  <keyword>Cardiorespiratory fitness</keyword>
  <keyword>Adiposity</keyword>
  <keyword>Cardiovascular fitness</keyword>
  <keyword>Aerobic capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <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/NCT03236363
org study id: PI16b/01919
nct id: NCT03236363
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Project which objective is to test the effectiveness of a classroom-based physical activity
      intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and
      executive function.
In the last decade, this research group has tested the effectiveness of three interventions
      following after-school intervention model. The first one (MOVI) was carried out in
      peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a
      moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement
      of the lipid profile, without significantly improving the global cardiometabolic risk because
      it did not produce a reduction in insulinemia.

      The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased
      the duration and intensity of the sessions, and was focused on the development of muscular
      strength in order to improve insulinemia levels. The intervention showed proved
      effectiveness; in addition, the data from this intervention showed a modest improvement in
      girls' aerobic capacity, but not in boys.

      The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses
      that vigorous physical activity at early ages could produce lifelong cardio-metabolic
      benefits. Data submitted for publication in this study show that, as in the case of the
      IDEFICS study in children of similar age, the intervention was not effective in improving
      fitness.

      This new edition (MOVI-da10!) has been designed following integrated physical activity
      intervention and active breaks designs, and as a controlled cluster-randomized trial
      including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two
      intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third
      grade preschool children (about 5 years old), using two different design. Three of them will
      receive an active breaks intervention, in which twice a day a 10 minutes breaks standard
      physical activity will be developed, and the other three will receive twice a day a 10
      minutes of enriched physical activity integrated in the curriculum. The other three schools
      will be allocated to the control group (CG).

      During an academic year the MOVIda10! interventions will consist of: i) an integrated across
      the curriculum cognitive demanding physical activity program including two active breaks
      lasting 10 min, five days/week; and ii) an active breaks physical activity program including
      two active breaks lasting 10 min, five days/week. In the CG regular physical activity will
      continue.

      At the end of the school year the researchers will determine main outcome variables: changes
      in VO2max, body fat by bioimpedance and executive function.

      The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on
      physical activity integrated in the curriculum for third grade preschool children, will be:

        1. Moderately increase the executive function and academic performance in the IGs versus
           the CG (effect size 0.5).

        2. Increase aerobic capacity (VO2max) in IGs versus CG by 3%.

        3. Reduced body fat in IGs versus CG by 3%
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Executive function
time frame: One year
description: Executive function will be measured by standardized test using the NIH toolbox
measure: VO2 max
time frame: One year
description: It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children.
measure: Motor skills
time frame: One year
description: By using the Movement Assessment Battery for Children 2 (M-ABC 2)
measure: Body fat%
time frame: One year
description: Body fat percentage measured by Bioimpedance analysis
measure: Health-related quality of life
time frame: One year
description: By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.
arm group label: MOVI-da 10! active breaks
arm group type: Experimental
description: It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
arm group label: Control
arm group type: No Intervention
description: No intervention
arm group label: MOVI-da10! integrated physical activity
arm group type: Experimental
description: It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
intervention type: Behavioral
intervention name: MOVI-da10! active breaks
description: MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
arm group label: MOVI-da 10! active breaks
intervention type: Behavioral
intervention name: MOVI-da10! integrated physical activity
description: MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
arm group label: MOVI-da10! integrated physical activity
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vicente Martinez-Vizcaino, PhD, MD
role: Principal Investigator
affiliation: Social and Health Care Research Center, University of Castilla-La Mancha
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No