Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016296
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-22
Brief Title:
Combined Movement and Storytelling Intervention on Physical Performance in Children
Sponsor:
Universidad Católica del Maule
Organization:
Universidad Católica del Maule
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMSIChild
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 ie 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 322 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 070 points considering an alpha level of 005 with a power of 80 and an expected loss of 15 The GPower program version 3196 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 412 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 ie 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 N1052021 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
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 ie 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 322 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 070 points considering an alpha level of 005 with a power of 80 and an expected loss of 15 The GPower program version 3196 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 412 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 ie 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 N1052021 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None