Combined Movement and Storytelling Intervention on Physical Performance in Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Combined Movement and Storytelling Intervention
  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 narrati

Первичные конечные точки

• Change from fundamental Motor Skills [Срок оценки: 2 weeks]
• Change from language development [Срок оценки: 2 weeks]
• Change from physical activity level [Срок оценки: 2 weeks]

Вторичные конечные точки (5)

• Bipedal height [Срок оценки: 2 weeks]
• Circumferences and skinfolds [Срок оценки: 2 weeks]
• Sociodemographic Variables [Срок оценки: 2 weeks]
• Body weight [Срок оценки: 2 weeks]
• Body mass index [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Poliderportivo San Clemente — San Clemente

Публикации

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• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical PMID 33239350
• den Uil AR, Janssen M, Busch V, Kat IT, Scholte RHJ. The relationships between children's motor competence, physical activity, perceived motor competence, physical fitness and weight status in relation to age. PLoS One. 2023 Apr 14;18(4):e0278438. doi: 10.1371/journal.pone.0278438. eCollection 2023. PMID 37058506
• Ma FF, Luo DM. Relationships between physical activity, fundamental motor skills, and body mass index in preschool children. Front Public Health. 2023 Apr 12;11:1094168. doi: 10.3389/fpubh.2023.1094168. eCollection 2023. PMID 37124831
• Duncan MJ, Hall C, Eyre E, Barnett LM, James RS. Pre-schoolers fundamental movement skills predict BMI, physical activity, and sedentary behavior: A longitudinal study. Scand J Med Sci Sports. 2021 Apr;31 Suppl 1:8-14. doi: 10.1111/sms.13746. PMID 33871088
• Webster EK, Sur I, Stevens A, Robinson LE. Associations between body composition and fundamental motor skill competency in children. BMC Pediatr. 2021 Oct 11;21(1):444. doi: 10.1186/s12887-021-02912-9. PMID 34629074
• Bolger LE, Bolger LA, O'Neill C, Coughlan E, O'Brien W, Lacey S, Burns C, Bardid F. Global levels of fundamental motor skills in children: A systematic review. J Sports Sci. 2021 Apr;39(7):717-753. doi: 10.1080/02640414.2020.1841405. Epub 2020 Dec 30. PMID 33377417
• Mule D, Jeger I, Dotsch J, Breido F, Ferrari N, Joisten C. Correlation between Language Development and Motor Skills, Physical Activity, and Leisure Time Behaviour in Preschool-Aged Children. Children (Basel). 2022 Mar 18;9(3):431. doi: 10.3390/children9030431. PMID 35327803

Идентификаторы

NCT: NCT06016296 · 105/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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