Clinical trial NCT06016296: Combined Movement and Storytelling Intervention on Physical Performance in Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preschool Children
Keywords: Motor Skills
Language Acquisition
Exercise
Preschool
Child
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 144
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from fundamental Motor Skills
timeFrame: 2 weeks
measure: Change from language development
timeFrame: 2 weeks
measure: Change from physical activity level
timeFrame: 2 weeks
Secondary outcomes:
measure: Bipedal height
timeFrame: 2 weeks
measure: Circumferences and skinfolds
timeFrame: 2 weeks
measure: Sociodemographic Variables
timeFrame: 2 weeks
measure: Body weight
timeFrame: 2 weeks
measure: Body mass index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Clemente
country: Chile
facility: Poliderportivo San Clemente
state: Region Del Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Pablo Valdés-Badilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willumsen J, Bull F. Development of WHO Guidelines on Physical Activity, Sedentary Behavior, and Sleep for Children Less Than 5 Years of Age. J Phys Act Health. 2020 Jan 1;17(1):96-100. doi: 10.1123/jpah.2019-0457.
citation: 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 activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Lin J, Zhang R, Shen J, Zhou A. Effects of school-based neuromuscular training on fundamental movement skills and physical fitness in children: a systematic review. PeerJ. 2022 Jul 8;10:e13726. doi: 10.7717/peerj.13726. eCollection 2022.
citation: Van Capelle A, Broderick CR, van Doorn N, E Ward R, Parmenter BJ. Interventions to improve fundamental motor skills in pre-school aged children: A systematic review and meta-analysis. J Sci Med Sport. 2017 Jul;20(7):658-666. doi: 10.1016/j.jsams.2016.11.008. Epub 2017 Jan 23.
citation: Han X, Zhao M, Kong Z, Xie J. Association between fundamental motor skills and executive function in preschool children: A cross-sectional study. Front Psychol. 2022 Aug 25;13:978994. doi: 10.3389/fpsyg.2022.978994. eCollection 2022.
citation: Jylanki P, Mbay T, Hakkarainen A, Saakslahti A, Aunio P. The effects of motor skill and physical activity interventions on preschoolers' cognitive and academic skills: A systematic review. Prev Med. 2022 Feb;155:106948. doi: 10.1016/j.ypmed.2021.106948. Epub 2021 Dec 30.
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.
citation: Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012 Nov 14;11(11):MR000030. doi: 10.1002/14651858.MR000030.pub2.
citation: Parker K, Nunns MP, Xiao Z, Ford T, Ukoumunne OC. Characteristics and practices of school-based cluster randomised controlled trials for improving health outcomes in pupils in the UK: a systematic review protocol. BMJ Open. 2021 Feb 15;11(2):e044143. doi: 10.1136/bmjopen-2020-044143.
citation: Manacero S, Nunes ML. Longitudinal study of sleep behavior and motor development in low-birth-weight preterm children from infancy to preschool years. J Pediatr (Rio J). 2021 Jan-Feb;97(1):44-51. doi: 10.1016/j.jped.2019.10.010. Epub 2020 Feb 20.
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.
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: 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: 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: 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: 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: 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: 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: 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.