Combined Movement and Storytelling Intervention on Physical Performance in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Preschool Children

Intervention / Treatment
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* Other: Combined Movement and Storytelling Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be enrolled in the educational center (school, college or kindergarten) that commits to participate in the intervention. Age range between 3 to 6 years old. Attend ≥ 85% of the sessions scheduled for the CMSI. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper middle level experimental groups<br>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. | Other: Combined Movement and Storytelling Intervention<br>* 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.<br>* Other names: Physical fitness;|
| No Intervention: Upper middle level control groups<br>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. | |
| Experimental: Transition level 1 experimental groups<br>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. | Other: Combined Movement and Storytelling Intervention<br>* 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.<br>* Other names: Physical fitness;|
| No Intervention: Transition level 1 control groups<br>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. | |
| Experimental: Transition level 2 experimental groups<br>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. | Other: Combined Movement and Storytelling Intervention<br>* 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.<br>* Other names: Physical fitness;|
| No Intervention: Transition level 2 control groups<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from fundamental Motor Skills | 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. | 2 weeks | 
| Change from language development | 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. | 2 weeks | 
| Change from physical activity level | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bipedal height | 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). | 2 weeks | 
| Circumferences and skinfolds | 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. | 2 weeks | 
| Sociodemographic Variables | 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. | 2 weeks | 
| Body weight | Will be determined using an electronic scale (Tanita BC-730 Tokyo, Japan; accuracy of 0.1 kg) in kg. | 2 weeks | 
| Body mass index | Will be computed by dividing the body weight by the square of the bipedal height (kg/m2). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor Skills, Language Acquisition, Exercise, Preschool, Child