<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/NCT03236337</url>
  </required_header>
  <id_info>
    <org_study_id>PI16/01919</org_study_id>
    <nct_id>NCT03236337</nct_id>
  </id_info>
  <brief_title>Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!</brief_title>
  <official_title>Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Subclinical Atherosclerosis by Increasing Aerobic Cardiorespiratory Fitness: MOVI-daFit</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 an extracurricular physical activity&#xD;
      intervention based on high intensity interval training (MOVI-daFit!) on improving&#xD;
      cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic&#xD;
      performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last decade, this research group has tested the effectiveness of three interventions&#xD;
      following this model. The first one (MOVI) was carried out in peripuberal age children (4th&#xD;
      and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the&#xD;
      adiposity of schoolchildren with higher BMI, an improvement of the lipid profile, without&#xD;
      significantly improving the global cardiometabolic risk because it did not produce a&#xD;
      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-daFit!) has been designed as controlled cluster-randomized trial&#xD;
      including 10 schools from Cuenca province, Spain. Five schools will be randomized to&#xD;
      intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children&#xD;
      in fourth and fifth school grades (9-11 years old). The other five schools will be allocated&#xD;
      to the control group (CG).&#xD;
&#xD;
      During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in&#xD;
      out of school hours, four times by week, one hour sessions of a standardized recreative, non&#xD;
      competitive, physical activity intervention based on games adapted to high intensity interval&#xD;
      training methodology (MOVI-daFit!). In the CG regular physical activity will 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, reactive hyperemia index, academic achievement,&#xD;
      executive function, and biochemical analytic procedures including lipid profile, insulin,&#xD;
      HbA1, C ultrasensitive reactive protein and BDNF.&#xD;
&#xD;
      The hypotheses of this new edition will be that the MOVI-daFit! based on high intensity&#xD;
      interval training (HITT) adapted for the 4th and 5th schoolchildren, will:&#xD;
&#xD;
        1. Increase the aerobic capacity (VO2max).&#xD;
&#xD;
        2. Reduce the percentage of body fat in the GI versus the GC by 6%.&#xD;
&#xD;
        3. Improve executive function and academic performance.&#xD;
&#xD;
        4. Improve subclinical markers of atherosclerosis (endothelial function and carotid&#xD;
           intima-media thickness).&#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>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 from 5 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDNF blood determination</measure>
    <time_frame>One year</time_frame>
    <description>Biochemical determinations will be performed in order to determine Brain-derived neurotrophic factor. It is a protein that, in humans, is encoded by the BDNF gene. BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. In the brain, it is active in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>One year</time_frame>
    <description>By using the KIDSCREEN-27 for children from 8 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep behaviors and sleep problems by questionnaire</measure>
    <time_frame>One year</time_frame>
    <description>By using the Spanish version of the Children's Sleep Habits Questionnaire (CSHQ) completed by parents. Four questions will be added in order to ask about bedtime, waking up, getting up, and total number of hours of sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality by accelerometry</measure>
    <time_frame>One year</time_frame>
    <description>The latency, quantity, duration of sleep and the number of awakenings will also be measured by accelerometry in a subsample of 242 school children.&#xD;
Actigraphy (ACT) is a non-invasive method used to study sleep-wake patterns and circadian rhythms by assessing movement. The GENEActive (ActivInsights) monitor will be used, a wristwatch device that monitors activity levels for extended continuous periods.</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>Physical activity</measure>
    <time_frame>One year</time_frame>
    <description>In a sub-sample of 242 randomly selected school children will be measured objectively by GENEActive (ActivInsights) accelerometers during seven consecutive days (including nights), with a fixed frequency of 85.7Hz to collect raw acceleration data measured in g for each axis of motion (x, y, z).</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>Academic achievement</measure>
    <time_frame>One year</time_frame>
    <description>Children´s mean scores on mathematics and language will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Stiffness</measure>
    <time_frame>One year</time_frame>
    <description>Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>One year</time_frame>
    <description>Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subclinical atherosclerosis</measure>
    <time_frame>One year</time_frame>
    <description>Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive function</measure>
    <time_frame>One year</time_frame>
    <description>Executive function will be measured by standardized tests using the NIH toolbox</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose profile</measure>
    <time_frame>One year</time_frame>
    <description>Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>One year</time_frame>
    <description>Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin profile</measure>
    <time_frame>One year</time_frame>
    <description>Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasensitive protein profile</measure>
    <time_frame>One year</time_frame>
    <description>C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">570</enrollment>
  <condition>Physical Activity</condition>
  <condition>Obesity</condition>
  <condition>Children</condition>
  <condition>Cardiovascular</condition>
  <condition>Cardiorespiratory Fitness</condition>
  <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 intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>- MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MOVI intervention</intervention_name>
    <description>MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.</description>
    <arm_group_label>MOVI intervention</arm_group_label>
    <other_name>MOVI-da Fit!</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Schools must have at least one full classrooms for both the 4th and 5th grade of&#xD;
             primary school.&#xD;
&#xD;
          -  The approval of boards of governors will be necessary.&#xD;
&#xD;
          -  Children's parents or legal representatives will sign an informed consent to&#xD;
             participate.&#xD;
&#xD;
          -  Parents will be invited to collaborate by filling in questionnaires with regard to&#xD;
             family leisure habits, sleeping, eating and getting around town.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Severe Spanish language learning difficulties.&#xD;
&#xD;
          -  Serious physical or mental disorders identified by parents or teachers that would&#xD;
             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-daFit!).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vicente Martínez-Vizcaíno, 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>Health and Social Research Centre, University of Castilla-La Mancha</name>
      <address>
        <city>Cuenca</city>
        <zip>16071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mairena Sánchez-López</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 27, 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>Atherosclerosis</keyword>
  <keyword>Aerobic capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <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/NCT03236337
org study id: PI16/01919
nct id: NCT03236337
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 an extracurricular physical activity
      intervention based on high intensity interval training (MOVI-daFit!) on improving
      cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic
      performance.
In the last decade, this research group has tested the effectiveness of three interventions
      following this 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-daFit!) has been designed as controlled cluster-randomized trial
      including 10 schools from Cuenca province, Spain. Five schools will be randomized to
      intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children
      in fourth and fifth school grades (9-11 years old). The other five schools will be allocated
      to the control group (CG).

      During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in
      out of school hours, four times by week, one hour sessions of a standardized recreative, non
      competitive, physical activity intervention based on games adapted to high intensity interval
      training methodology (MOVI-daFit!). 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, reactive hyperemia index, academic achievement,
      executive function, and biochemical analytic procedures including lipid profile, insulin,
      HbA1, C ultrasensitive reactive protein and BDNF.

      The hypotheses of this new edition will be that the MOVI-daFit! based on high intensity
      interval training (HITT) adapted for the 4th and 5th schoolchildren, will:

        1. Increase the aerobic capacity (VO2max).

        2. Reduce the percentage of body fat in the GI versus the GC by 6%.

        3. Improve executive function and academic performance.

        4. Improve subclinical markers of atherosclerosis (endothelial function and carotid
           intima-media thickness).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
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 from 5 years.
measure: BDNF blood determination
time frame: One year
description: Biochemical determinations will be performed in order to determine Brain-derived neurotrophic factor. It is a protein that, in humans, is encoded by the BDNF gene. BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. In the brain, it is active in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking.
measure: Health-related quality of life
time frame: One year
description: By using the KIDSCREEN-27 for children from 8 years.
measure: Sleep behaviors and sleep problems by questionnaire
time frame: One year
description: By using the Spanish version of the Children's Sleep Habits Questionnaire (CSHQ) completed by parents. Four questions will be added in order to ask about bedtime, waking up, getting up, and total number of hours of sleep.
measure: Sleep quality by accelerometry
time frame: One year
description: The latency, quantity, duration of sleep and the number of awakenings will also be measured by accelerometry in a subsample of 242 school children.
Actigraphy (ACT) is a non-invasive method used to study sleep-wake patterns and circadian rhythms by assessing movement. The GENEActive (ActivInsights) monitor will be used, a wristwatch device that monitors activity levels for extended continuous periods.
measure: Motor skills
time frame: One year
description: By using the Movement Assessment Battery for Children 2 (M-ABC 2)
measure: Physical activity
time frame: One year
description: In a sub-sample of 242 randomly selected school children will be measured objectively by GENEActive (ActivInsights) accelerometers during seven consecutive days (including nights), with a fixed frequency of 85.7Hz to collect raw acceleration data measured in g for each axis of motion (x, y, z).
measure: Body fat%
time frame: One year
description: Body fat percentage measured by Bioimpedance analysis
measure: Academic achievement
time frame: One year
description: Children´s mean scores on mathematics and language will be considered
measure: Arterial Stiffness
time frame: One year
description: Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA).
measure: Pulse wave velocity
time frame: One year
description: Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia)
measure: Subclinical atherosclerosis
time frame: One year
description: Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86)
measure: Executive function
time frame: One year
description: Executive function will be measured by standardized tests using the NIH toolbox
measure: Glucose profile
time frame: One year
description: Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics
measure: Lipid profile
time frame: One year
description: Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics.
measure: Insulin profile
time frame: One year
description: Insulin (µU/L) level will be determined by using the Architect platform of Abbott ®
measure: Ultrasensitive protein profile
time frame: One year
description: C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics
arm group label: Control
arm group type: No Intervention
description: No intervention
arm group label: MOVI intervention
arm group type: Experimental
description: - MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
intervention type: Behavioral
intervention name: MOVI intervention
description: MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
arm group label: MOVI intervention
other name: MOVI-da Fit!
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vicente Martínez-Vizcaíno, PhD, MD
role: Principal Investigator
affiliation: Social and Health Care Research Center, University of Castilla-La Mancha
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Obesity
sharing ipd: No