xml: <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/NCT06016296</url>
    </required_header>
    <id_info>
      <org_study_id>105/2021</org_study_id>
      <nct_id>NCT06016296</nct_id>
    </id_info>
    <brief_title>Combined Movement and Storytelling Intervention on Physical Performance in Children</brief_title>
    <acronym>CMSI&amp;Child</acronym>
    <official_title>Effects of Combined Movement and Storytelling Intervention on Fundamental Motor Skills, Language Development and Physical Activity Level in Children Aged 3 to 6 Years: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Católica del Maule</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Católica del Maule</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>
        This study protocol aims to analyze and compare the effects of combined movement and&#xD;
        storytelling intervention (CMSI) on fundamental motor skills (locomotor skills and object&#xD;
        control), language development (language comprehension, language expression, vocabulary and&#xD;
        language description), and physical activity levels (light, moderate to vigorous intensity,&#xD;
        and sedentary time) in children aged 3 to 6 years. The sample will consist of 144 children of&#xD;
        12 classes group, randomly assigned to 3 experimental groups (n= 72 children) and 3 control&#xD;
        groups (n= 72 children), belonging to 4 classes group of upper middle level classes (2&#xD;
        experimental and 2 control), 4 transition level 1 classes (2 experimental and 2 control) and&#xD;
        4 transition level 2 classes (2 experimental and 2 control). The experimental groups will&#xD;
        perform the CMSI for 3 sessions (40-minute per session) per week over 12-weeks (using one&#xD;
        motor story per week), while the control groups will not receive any treatment. The main&#xD;
        outcome will provide information about fundamental motor skills, language development, and&#xD;
        physical activity levels. It is hypothesized that the CMSI has the potential to generate&#xD;
        significant increases in selected assessments. If this intervention proves to be beneficial,&#xD;
        if could contribute to preschoolers children curricula.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study includes an experimental design (randomized controlled trial), double-blind,&#xD;
        repeated measures and parallel groups (6 interventions and 6 controls) considering previous&#xD;
        studies and a quantitative approach. The methodology followed will be the Consolidated&#xD;
        Standards of Reporting Trials Statement (CONSORT) methodology.&#xD;
  &#xD;
        It is expected to recruit 12 children from each classes group (without distinction of sex).&#xD;
        The distribution of the classes groups (12 classes group) will be in 3 experimental groups (6&#xD;
        classes group, n ± 72 children) and 3 control groups (6 classes group, n ± 72 children). The&#xD;
        distribution by clusters or strata is justified by the fact that the use of individual&#xD;
        randomization would imply a high probability of contaminating the control groups, since it is&#xD;
        unfeasible to prohibit children interaction in classrooms or school recreational spaces&#xD;
        (i.e., playgrounds, hallways, laboratories), which is where the study intervention will be&#xD;
        carried out. The sample size calculation indicates that the ideal number of participants per&#xD;
        group is 10. As agreed in a previous study, a mean difference of 3.22 total score of&#xD;
        locomotor skills domains was used for this calculation as the minimum difference necessary&#xD;
        for substantial clinical relevance, with a standard deviation of 0.70 points, considering an&#xD;
        alpha level of 0.05 with a power of 80% and an expected loss of 15%. The GPower program&#xD;
        (version 3.1.9.6, Franz Faul, Universiät Kiel, Kiel, Germany) will be used to calculate the&#xD;
        statistical power.&#xD;
  &#xD;
        The 12 classes group will be selected in 4 upper middle level classes (2 experimental and 2&#xD;
        control; age range between 3 to 4 years), 4 transition level 1 classes (2 experimental and 2&#xD;
        control; age range between 4 to 5 years) and 4 transition level 2 classes (2 experimental and&#xD;
        2 control; age range between 5 to 6 years), which will be randomized by stratified sampling,&#xD;
        which consists of segmenting the classes that agreed to participate in the study according to&#xD;
        educational levels (strata) and then performing a random sampling on each one of them, using&#xD;
        R statistical software, version 4.1.2. This study is considered double-blind because the&#xD;
        measurements will be performed by professionals external to the research.&#xD;
  &#xD;
        The investigators estimate the participation of 144 children residing in the Maule region,&#xD;
        Chile who meet the following inclusion criteria: (i) be enrolled in the educational center&#xD;
        (school, college or kindergarten) that commits to participate in the intervention; (ii) age&#xD;
        range between 3 to 6 years old; (iii) attend ≥ 85% of the sessions scheduled for the combined&#xD;
        movement and storytelling intervention (CMSI). As for the exclusion criteria, will be the&#xD;
        following: (i) children with musculoskeletal injuries or medical contraindications (i.e.,&#xD;
        congenital heart disease, fever, diarrhea or general malaise) that would prevent their normal&#xD;
        performance in the assessments and intervention and; (ii) children with permanent educational&#xD;
        needs mentioned in Decree Nº83 of the Chilean Ministry of Education, such as, visual,&#xD;
        hearing, intellectual or multiple disabilities, dysphasia or autistic disorder.&#xD;
  &#xD;
        The current protocol has been reviewed and approved by the Scientific Ethics Committee of the&#xD;
        Universidad Católica del Maule, Chile (approval number: N°105/2021, 04 August 2021) and&#xD;
        developed following the Declaration of Helsinki for work with human beings.&#xD;
  &#xD;
        Before starting the intervention, during the last week of March 2024 (for two weeks),&#xD;
        children will be evaluated in the variables considered for the research, later, from the&#xD;
        third week of March to the first week of June 2024 (12 weeks) will participate in CMSI. After&#xD;
        the intervention (second week of June 2024), for two weeks, the children will undergo the&#xD;
        same initial assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 14, 2024</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>
      <intervention_model_description>The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>The assessments will be scheduled two weeks before and after the intervention with a team of evaluators who will not have information about the training groups, nor will the participants know their identities. That is, a double-blind shield</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from fundamental Motor Skills</measure>
      <time_frame>2 weeks</time_frame>
      <description>It will be assessed by means of the test of gross motor development-second edition (TGMD-2). This battery measures 12 fundamental motor skilss in two different domains (locomotor skills and object control), the locomotor skills domain contains 6 assessments: (i) running, (ii) galloping, (iii) hopping on one foot, (iv) long jumping, (v) horizontal jumping and, (vi) lateral sliding. The object control domain also includes 6 assessments: (i) batting a stationary ball, (ii) stationary dribbling, (iii) catching a ball, (iv) kicking a ball, (v) throwing a ball and, (vi) rolling a ball. Estimated administration time is ≤ 10 minutes per children. The 6 locomotion skills and 6 object control include 24 criteria, allowing a total score from 0 to 48 points. The higher score, better FMS.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from language development</measure>
      <time_frame>2 weeks</time_frame>
      <description>The language test for preschoolers (TELEPRE), will be used. The purpose of this assessment is to measure the language of children in initial educational levels (3 to 6 years old) by means of 4 domains: (i) language comprehension, (ii) language expression, (iii) vocabulary and, (iv) language description. The administration of the instrument requires a booklet of questions, some objects (bottle, toy car, pencil, plate, needle, cup, paintbrush, screw, sponge, small ball, button, small book, spoon, scissors, matchbox; plus, three objects that serve as distractors) and 3 representative pictures of situations (i.e., serving milk to a cat, setting the table and being in a toy store) to be described by the child. To administer the instrument, a room free of disturbing noises is required, in which the evaluator, the child and a classroom assistant will be present. The estimated application time is ≤ 25 minutes. The higher score, better language development.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from physical activity level</measure>
      <time_frame>2 weeks</time_frame>
      <description>It will be objectively monitored by accelerometers (ActiGraph GT9X, Pensacola, FL, USA). The device will be worn at the waist on an elastic belt, at the mid-axillary line on the right side. Children will be instructed to wear the accelerometer 24 hours a day, for at least 7 days, including 2 weekend days, and only removed the device when bathing or engaged in water activities. The minimum amount of data considered acceptable for analysis purposes will be 5 days (including one weekend day), with at least 10 hours/day of wear time. Light, moderate to vigorous intensity, and sedentary time will be considered to analysis, while sleep time will be not taken into account. Data will be verified using Actilife software version 5.6 (ActiGraph, Pensacola, FL, USA). Consecutive 20-min blocks of 0 count will considered as non-use of the device and discarded from the analyses.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bipedal height</measure>
      <time_frame>2 weeks</time_frame>
      <description>Will be measured by placing a tape measure (Bodymeter 206, SECA, Germany; accuracy of 0.1 cm) on the wall and utilizing the Frankfort plane in a horizontal position (assessment in cm).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Circumferences and skinfolds</measure>
      <time_frame>2 weeks</time_frame>
      <description>Will be measured with an inextensible tape measure (Seca-201, Germany) with an accuracy of 0.1 cm. Similarly, skinfolds (mm) measured in the bicipital, tricipital, subscapular and suprailiac regions will be measured using a plicometer (Harpenden-FG1056, England; accuracy of 0.2 mm) that exerts a constant pressure of 10 g/mm2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sociodemographic Variables</measure>
      <time_frame>2 weeks</time_frame>
      <description>Legal guardians will be asked to respond to the following: (i) child's name; (ii) child's date of birth; (iii) in which country the child was born; (iv) in which country was I born; (v) what is my family relationship to the child; (vi) marital status of the parents or guardians; (vii) in what area does the child reside; (viii) the place where the child lives has a yard; (ix) how many people live with the child; (x) how many persons work in participants household; (xi) what is the total family income of the people living with the child (approximately); (xii) what is the highest level of schooling participant have.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>2 weeks</time_frame>
      <description>Will be determined using an electronic scale (Tanita BC-730 Tokyo, Japan; accuracy of 0.1 kg) in kg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>2 weeks</time_frame>
      <description>Will be computed by dividing the body weight by the square of the bipedal height (kg/m2).</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Preschool Children</condition>
    <arm_group>
      <arm_group_label>Upper middle level experimental groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (upper middle). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Upper middle level control groups</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The upper middle level control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transition level 1 experimental groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 1). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transition level 1 control groups</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The transition level 1 control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transition level 2 experimental groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 2). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Transition level 2 control groups</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The transition level 2 control groups (n= 2; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Combined Movement and Storytelling Intervention</intervention_name>
      <description>The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.</description>
      <arm_group_label>Transition level 1 experimental groups</arm_group_label>
      <arm_group_label>Transition level 2 experimental groups</arm_group_label>
      <arm_group_label>Upper middle level experimental groups</arm_group_label>
      <other_name>Physical fitness</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be enrolled in the educational center (school, college or kindergarten) that commits&#xD;
               to participate in the intervention.&#xD;
  &#xD;
            -  Age range between 3 to 6 years old.&#xD;
  &#xD;
            -  Attend ≥ 85% of the sessions scheduled for the CMSI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with musculoskeletal injuries or medical contraindications (i.e., congenital&#xD;
               heart disease, fever, diarrhea or general malaise) that would prevent their normal&#xD;
               performance in the assessments and intervention.&#xD;
  &#xD;
            -  Children with permanent educational needs mentioned in Decree Nº83 of the Chilean&#xD;
               Ministry of Education, such as, visual, hearing, intellectual or multiple&#xD;
               disabilities, dysphasia or autistic disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pablo Valdés-Badilla, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Católica del Maule</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pablo Valdés-Badilla, PhD</last_name>
      <phone>+56971258824</phone>
      <email>valdesbadilla@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rodrigo Vargas-Vitoria, PhD</last_name>
      <phone>+56 71 298 6000</phone>
      <email>rvargas@ucm.cl</email>
    </overall_contact_backup>
    <link>
      <url>https://especial.mineduc.cl/wp-content/uploads/sites/31/2016/08/Decreto-83-2015.pdf</url>
      <description>Chilean Ministry of Education. Diversificacion de la enseñanza</description>
    </link>
    <link>
      <url>https://33202576.weebly.com/uploads/1/4/6/8/14680198/tgmd-2-2.pdf</url>
      <description>Test of gross motor development-2</description>
    </link>
    <link>
      <url>https://es.scribd.com/document/76165919/Prueba-TELEPRE</url>
      <description>Prueba de Desarrollo del Lenguaje para Pre-Escolares TELEPRE 1</description>
    </link>
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    <results_reference>
      <citation>Valentini NC. Validity and reliability of the TGMD-2 for Brazilian children. J Mot Behav. 2012;44(4):275-80. doi: 10.1080/00222895.2012.700967. Epub 2012 Aug 2.</citation>
      <PMID>22857518</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim S, Kim MJ, Valentini NC, Clark JE. Validity and reliability of the TGMD-2 for South Korean children. J Mot Behav. 2014;46(5):351-6. doi: 10.1080/00222895.2014.914886. Epub 2014 Jun 10.</citation>
      <PMID>24915525</PMID>
    </results_reference>
    <results_reference>
      <citation>Estivaleti JMO, Bergamo RR, Oliveira LC, Beltran DCG, Silva Junior JPD, Santos MD, Matsudo VKR. Physical activity level measured by accelerometry and physical fitness of schoolchildren. Rev Paul Pediatr. 2022 Sep 9;41:e2021230. doi: 10.1590/1984-0462/2023/41/2021230. eCollection 2022.</citation>
      <PMID>36102399</PMID>
    </results_reference>
    <results_reference>
      <citation>Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nystrom C, Mora-Gonzalez J, Lof M, Labayen I, Ruiz JR, Ortega FB. Accelerometer Data Collection and Processing Criteria to Assess Physical Activity and Other Outcomes: A Systematic Review and Practical Considerations. Sports Med. 2017 Sep;47(9):1821-1845. doi: 10.1007/s40279-017-0716-0.</citation>
      <PMID>28303543</PMID>
    </results_reference>
    <results_reference>
      <citation>Kuzik N, Naylor PJ, Spence JC, Carson V. Movement behaviours and physical, cognitive, and social-emotional development in preschool-aged children: Cross-sectional associations using compositional analyses. PLoS One. 2020 Aug 18;15(8):e0237945. doi: 10.1371/journal.pone.0237945. eCollection 2020.</citation>
      <PMID>32810172</PMID>
    </results_reference>
    <results_reference>
      <citation>Robinson LE, Stodden DF, Barnett LM, Lopes VP, Logan SW, Rodrigues LP, D'Hondt E. Motor Competence and its Effect on Positive Developmental Trajectories of Health. Sports Med. 2015 Sep;45(9):1273-1284. doi: 10.1007/s40279-015-0351-6.</citation>
      <PMID>26201678</PMID>
    </results_reference>
    <results_reference>
      <citation>Logan SW, Ross SM, Chee K, Stodden DF, Robinson LE. Fundamental motor skills: A systematic review of terminology. J Sports Sci. 2018 Apr;36(7):781-796. doi: 10.1080/02640414.2017.1340660. Epub 2017 Jun 21.</citation>
      <PMID>28636423</PMID>
    </results_reference>
    <results_reference>
      <citation>Lyster SH, Lervag AO, Hulme C. Preschool morphological training produces long-term improvements in reading comprehension. Read Writ. 2016;29:1269-1288. doi: 10.1007/s11145-016-9636-x. Epub 2016 Mar 17.</citation>
      <PMID>27340335</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Católica del Maule</investigator_affiliation>
      <investigator_full_name>Pablo Valdés-Badilla</investigator_full_name>
      <investigator_title>Academic-Researcher of Department of Physical Activity Sciences</investigator_title>
    </responsible_party>
    <keyword>Motor Skills</keyword>
    <keyword>Language Acquisition</keyword>
    <keyword>Exercise</keyword>
    <keyword>Preschool</keyword>
    <keyword>Child</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Participant data will not be shared. The investigators will only disseminate the results of the study through scientific papers and presentations at scientific congresses.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016296
  org study id: 105/2021
  nct id: NCT06016296
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study protocol aims to analyze and compare the effects of combined movement and
        storytelling intervention (CMSI) on fundamental motor skills (locomotor skills and object
        control), language development (language comprehension, language expression, vocabulary and
        language description), and physical activity levels (light, moderate to vigorous intensity,
        and sedentary time) in children aged 3 to 6 years. The sample will consist of 144 children of
        12 classes group, randomly assigned to 3 experimental groups (n= 72 children) and 3 control
        groups (n= 72 children), belonging to 4 classes group of upper middle level classes (2
        experimental and 2 control), 4 transition level 1 classes (2 experimental and 2 control) and
        4 transition level 2 classes (2 experimental and 2 control). The experimental groups will
        perform the CMSI for 3 sessions (40-minute per session) per week over 12-weeks (using one
        motor story per week), while the control groups will not receive any treatment. The main
        outcome will provide information about fundamental motor skills, language development, and
        physical activity levels. It is hypothesized that the CMSI has the potential to generate
        significant increases in selected assessments. If this intervention proves to be beneficial,
        if could contribute to preschoolers children curricula.
  The study includes an experimental design (randomized controlled trial), double-blind,
        repeated measures and parallel groups (6 interventions and 6 controls) considering previous
        studies and a quantitative approach. The methodology followed will be the Consolidated
        Standards of Reporting Trials Statement (CONSORT) methodology.
  
        It is expected to recruit 12 children from each classes group (without distinction of sex).
        The distribution of the classes groups (12 classes group) will be in 3 experimental groups (6
        classes group, n ± 72 children) and 3 control groups (6 classes group, n ± 72 children). The
        distribution by clusters or strata is justified by the fact that the use of individual
        randomization would imply a high probability of contaminating the control groups, since it is
        unfeasible to prohibit children interaction in classrooms or school recreational spaces
        (i.e., playgrounds, hallways, laboratories), which is where the study intervention will be
        carried out. The sample size calculation indicates that the ideal number of participants per
        group is 10. As agreed in a previous study, a mean difference of 3.22 total score of
        locomotor skills domains was used for this calculation as the minimum difference necessary
        for substantial clinical relevance, with a standard deviation of 0.70 points, considering an
        alpha level of 0.05 with a power of 80% and an expected loss of 15%. The GPower program
        (version 3.1.9.6, Franz Faul, Universiät Kiel, Kiel, Germany) will be used to calculate the
        statistical power.
  
        The 12 classes group will be selected in 4 upper middle level classes (2 experimental and 2
        control; age range between 3 to 4 years), 4 transition level 1 classes (2 experimental and 2
        control; age range between 4 to 5 years) and 4 transition level 2 classes (2 experimental and
        2 control; age range between 5 to 6 years), which will be randomized by stratified sampling,
        which consists of segmenting the classes that agreed to participate in the study according to
        educational levels (strata) and then performing a random sampling on each one of them, using
        R statistical software, version 4.1.2. This study is considered double-blind because the
        measurements will be performed by professionals external to the research.
  
        The investigators estimate the participation of 144 children residing in the Maule region,
        Chile who meet the following inclusion criteria: (i) be enrolled in the educational center
        (school, college or kindergarten) that commits to participate in the intervention; (ii) age
        range between 3 to 6 years old; (iii) attend ≥ 85% of the sessions scheduled for the combined
        movement and storytelling intervention (CMSI). As for the exclusion criteria, will be the
        following: (i) children with musculoskeletal injuries or medical contraindications (i.e.,
        congenital heart disease, fever, diarrhea or general malaise) that would prevent their normal
        performance in the assessments and intervention and; (ii) children with permanent educational
        needs mentioned in Decree Nº83 of the Chilean Ministry of Education, such as, visual,
        hearing, intellectual or multiple disabilities, dysphasia or autistic disorder.
  
        The current protocol has been reviewed and approved by the Scientific Ethics Committee of the
        Universidad Católica del Maule, Chile (approval number: N°105/2021, 04 August 2021) and
        developed following the Declaration of Helsinki for work with human beings.
  
        Before starting the intervention, during the last week of March 2024 (for two weeks),
        children will be evaluated in the variables considered for the research, later, from the
        third week of March to the first week of June 2024 (12 weeks) will participate in CMSI. After
        the intervention (second week of June 2024), for two weeks, the children will undergo the
        same initial assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: The assessments will be scheduled two weeks before and after the intervention with a team of evaluators who will not have information about the training groups, nor will the participants know their identities. That is, a double-blind shield
  measure: Change from fundamental Motor Skills
  time frame: 2 weeks
  description: It will be assessed by means of the test of gross motor development-second edition (TGMD-2). This battery measures 12 fundamental motor skilss in two different domains (locomotor skills and object control), the locomotor skills domain contains 6 assessments: (i) running, (ii) galloping, (iii) hopping on one foot, (iv) long jumping, (v) horizontal jumping and, (vi) lateral sliding. The object control domain also includes 6 assessments: (i) batting a stationary ball, (ii) stationary dribbling, (iii) catching a ball, (iv) kicking a ball, (v) throwing a ball and, (vi) rolling a ball. Estimated administration time is ≤ 10 minutes per children. The 6 locomotion skills and 6 object control include 24 criteria, allowing a total score from 0 to 48 points. The higher score, better FMS.
  measure: Change from language development
  time frame: 2 weeks
  description: The language test for preschoolers (TELEPRE), will be used. The purpose of this assessment is to measure the language of children in initial educational levels (3 to 6 years old) by means of 4 domains: (i) language comprehension, (ii) language expression, (iii) vocabulary and, (iv) language description. The administration of the instrument requires a booklet of questions, some objects (bottle, toy car, pencil, plate, needle, cup, paintbrush, screw, sponge, small ball, button, small book, spoon, scissors, matchbox; plus, three objects that serve as distractors) and 3 representative pictures of situations (i.e., serving milk to a cat, setting the table and being in a toy store) to be described by the child. To administer the instrument, a room free of disturbing noises is required, in which the evaluator, the child and a classroom assistant will be present. The estimated application time is ≤ 25 minutes. The higher score, better language development.
  measure: Change from physical activity level
  time frame: 2 weeks
  description: It will be objectively monitored by accelerometers (ActiGraph GT9X, Pensacola, FL, USA). The device will be worn at the waist on an elastic belt, at the mid-axillary line on the right side. Children will be instructed to wear the accelerometer 24 hours a day, for at least 7 days, including 2 weekend days, and only removed the device when bathing or engaged in water activities. The minimum amount of data considered acceptable for analysis purposes will be 5 days (including one weekend day), with at least 10 hours/day of wear time. Light, moderate to vigorous intensity, and sedentary time will be considered to analysis, while sleep time will be not taken into account. Data will be verified using Actilife software version 5.6 (ActiGraph, Pensacola, FL, USA). Consecutive 20-min blocks of 0 count will considered as non-use of the device and discarded from the analyses.
  measure: Bipedal height
  time frame: 2 weeks
  description: Will be measured by placing a tape measure (Bodymeter 206, SECA, Germany; accuracy of 0.1 cm) on the wall and utilizing the Frankfort plane in a horizontal position (assessment in cm).
  measure: Circumferences and skinfolds
  time frame: 2 weeks
  description: Will be measured with an inextensible tape measure (Seca-201, Germany) with an accuracy of 0.1 cm. Similarly, skinfolds (mm) measured in the bicipital, tricipital, subscapular and suprailiac regions will be measured using a plicometer (Harpenden-FG1056, England; accuracy of 0.2 mm) that exerts a constant pressure of 10 g/mm2.
  measure: Sociodemographic Variables
  time frame: 2 weeks
  description: Legal guardians will be asked to respond to the following: (i) child's name; (ii) child's date of birth; (iii) in which country the child was born; (iv) in which country was I born; (v) what is my family relationship to the child; (vi) marital status of the parents or guardians; (vii) in what area does the child reside; (viii) the place where the child lives has a yard; (ix) how many people live with the child; (x) how many persons work in participants household; (xi) what is the total family income of the people living with the child (approximately); (xii) what is the highest level of schooling participant have.
  measure: Body weight
  time frame: 2 weeks
  description: Will be determined using an electronic scale (Tanita BC-730 Tokyo, Japan; accuracy of 0.1 kg) in kg.
  measure: Body mass index
  time frame: 2 weeks
  description: Will be computed by dividing the body weight by the square of the bipedal height (kg/m2).
  arm group label: Upper middle level experimental groups
  arm group type: Experimental
  description: The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (upper middle). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
  arm group label: Upper middle level control groups
  arm group type: No Intervention
  description: The upper middle level control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
  arm group label: Transition level 1 experimental groups
  arm group type: Experimental
  description: The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 1). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
  arm group label: Transition level 1 control groups
  arm group type: No Intervention
  description: The transition level 1 control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
  arm group label: Transition level 2 experimental groups
  arm group type: Experimental
  description: The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 2). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
  arm group label: Transition level 2 control groups
  arm group type: No Intervention
  description: The transition level 2 control groups (n= 2; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
  intervention type: Other
  intervention name: Combined Movement and Storytelling Intervention
  description: The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.
  arm group label: Transition level 1 experimental groups
  arm group label: Transition level 2 experimental groups
  arm group label: Upper middle level experimental groups
  other name: Physical fitness
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pablo Valdés-Badilla, PhD
  role: Principal Investigator
  affiliation: Universidad Católica del Maule
  last name: Pablo Valdés-Badilla, PhD
  phone: +56971258824
  email: valdesbadilla@gmail.com
  last name: Rodrigo Vargas-Vitoria, PhD
  phone: +56 71 298 6000
  email: rvargas@ucm.cl
  url: https://especial.mineduc.cl/wp-content/uploads/sites/31/2016/08/Decreto-83-2015.pdf
  description: Chilean Ministry of Education. Diversificacion de la enseñanza
  url: https://33202576.weebly.com/uploads/1/4/6/8/14680198/tgmd-2-2.pdf
  description: Test of gross motor development-2
  url: https://es.scribd.com/document/76165919/Prueba-TELEPRE
  description: Prueba de Desarrollo del Lenguaje para Pre-Escolares TELEPRE 1
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  PMID: 37058506
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  PMID: 34974071
  citation: Eyre ELJ, Clark CCT, Tallis J, Hodson D, Lowton-Smith S, Nelson C, Noon M, Duncan MJ. The Effects of Combined Movement and Storytelling Intervention on Motor Skills in South Asian and White Children Aged 5-6 Years Living in the United Kingdom. Int J Environ Res Public Health. 2020 May 13;17(10):3391. doi: 10.3390/ijerph17103391.
  PMID: 32414027
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  PMID: 32088142
  citation: Cano-Cappellacci M, Leyton FA, Carreno JD. Content validity and reliability of test of gross motor development in Chilean children. Rev Saude Publica. 2015;49:97. doi: 10.1590/S0034-8910.2015049005724. Epub 2015 Dec 31.
  PMID: 26815160
  citation: Valentini NC. Validity and reliability of the TGMD-2 for Brazilian children. J Mot Behav. 2012;44(4):275-80. doi: 10.1080/00222895.2012.700967. Epub 2012 Aug 2.
  PMID: 22857518
  citation: Kim S, Kim MJ, Valentini NC, Clark JE. Validity and reliability of the TGMD-2 for South Korean children. J Mot Behav. 2014;46(5):351-6. doi: 10.1080/00222895.2014.914886. Epub 2014 Jun 10.
  PMID: 24915525
  citation: Estivaleti JMO, Bergamo RR, Oliveira LC, Beltran DCG, Silva Junior JPD, Santos MD, Matsudo VKR. Physical activity level measured by accelerometry and physical fitness of schoolchildren. Rev Paul Pediatr. 2022 Sep 9;41:e2021230. doi: 10.1590/1984-0462/2023/41/2021230. eCollection 2022.
  PMID: 36102399
  citation: Migueles JH, Cadenas-Sanchez C, Ekelund U, Delisle Nystrom C, Mora-Gonzalez J, Lof M, Labayen I, Ruiz JR, Ortega FB. Accelerometer Data Collection and Processing Criteria to Assess Physical Activity and Other Outcomes: A Systematic Review and Practical Considerations. Sports Med. 2017 Sep;47(9):1821-1845. doi: 10.1007/s40279-017-0716-0.
  PMID: 28303543
  citation: Kuzik N, Naylor PJ, Spence JC, Carson V. Movement behaviours and physical, cognitive, and social-emotional development in preschool-aged children: Cross-sectional associations using compositional analyses. PLoS One. 2020 Aug 18;15(8):e0237945. doi: 10.1371/journal.pone.0237945. eCollection 2020.
  PMID: 32810172
  citation: Robinson LE, Stodden DF, Barnett LM, Lopes VP, Logan SW, Rodrigues LP, D'Hondt E. Motor Competence and its Effect on Positive Developmental Trajectories of Health. Sports Med. 2015 Sep;45(9):1273-1284. doi: 10.1007/s40279-015-0351-6.
  PMID: 26201678
  citation: Logan SW, Ross SM, Chee K, Stodden DF, Robinson LE. Fundamental motor skills: A systematic review of terminology. J Sports Sci. 2018 Apr;36(7):781-796. doi: 10.1080/02640414.2017.1340660. Epub 2017 Jun 21.
  PMID: 28636423
  citation: Lyster SH, Lervag AO, Hulme C. Preschool morphological training produces long-term improvements in reading comprehension. Read Writ. 2016;29:1269-1288. doi: 10.1007/s11145-016-9636-x. Epub 2016 Mar 17.
  PMID: 27340335
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Católica del Maule
  investigator full name: Pablo Valdés-Badilla
  investigator title: Academic-Researcher of Department of Physical Activity Sciences
  sharing ipd: No
  ipd description: Participant data will not be shared. The investigators will only disseminate the results of the study through scientific papers and presentations at scientific congresses.