Viewing Study NCT06488508



Ignite Creation Date: 2024-07-17 @ 11:43 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06488508
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-05
First Post: 2024-06-21

Brief Title: Move-play-explore in Early Childhood Education
Sponsor: Western Norway University of Applied Sciences
Organization: Western Norway University of Applied Sciences

Study Overview

Official Title: Move-play-explore in Early Childhood Education
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
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: MoveEarly
Brief Summary: Evidence is lacking about scalable effective and sustainable interventions to increase whole-child development in young children Targeting worrisome trends in physical inactivity and schoolification negatively affecting young children we will conduct a large cluster randomized controlled trial investigating the effects of professional development of kindergarten staff on kindergarten pedagogical practices regarding movement play and exploration and child health and development over 18 months The aim is to recruit 50 kindergartens and 500 children aged 4 years in one county in the western part of Norway to allow for detecting small to moderate effect sizes and ensuring a heterogeneous sample of kindergartens for the study of implementation Childrens physical mental and socio-emotional development as well as intervention implementation will be investigated The intervention will be developed with strong user involvement from kindergartens and relevant stakeholders to facilitate the development of sustainable solutions
Detailed Description: There are growing concerns about low physical activity levels among young children and schoolification of the kindergartens sector As 97 of 3-5-year-olds in Norway attend kindergarten the kindergarten is a unique arena for intervention laying the foundation for equitable development of health learning and life opportunities Yet evidence of scalable effective and sustainable interventions to increase physical activity and whole-child development among young children is lacking

In MoveEarly we will develop and test a pedagogical intervention focusing movement play and exploration to counteract trends of increased physical inactivity and instructional teaching practices For such an intervention to be sustainable kindergarten staff must lead the implementation of the pedagogical innovation Thus we will develop theory on move-play-explore as core elements of a child-responsive pedagogy investigate how this pedagogy affect child developmental outcomes develop knowledge on how professional developmentcontinuing education can be co-created among researchers and kindergartens staff and how such an intervention can be effectively implemented in the kindergarten sector

Two main research questions will be tested using both quantitative and qualitative methods applied to both the child and organizational levels

1 How does the MoveEarly intervention impact childrens movement competence creativity physical activity physical fitness playfulness explorative behaviour socio-emotional health well-being self-regulation and early academic learning
2 How does the MoveEarly intervention interact with different kindergarten contexts to produce various individual and organizational outcomes

These research questions will be investigated using a cluster RCT with randomization at the kindergarten level including short- 7-month and long-term 18-month follow-ups The intervention development will include strong involvement from kindergarten owners and staff to provide broad support buy-in and ownership from kindergarten staff and owners Thus we aim to combine a large-scale experimental study with tailored continuous improvement effort in this sector by taking each kindergartens contextual factors into account In this model to make adaptations within each kindergarten is not considered a lack of fidelity rather it is a desired process of institutionalization overcoming a common criticism of clinical trials as it increases the value for later scaling and dissemination to the real-world setting In this way the aim is to create sustainable solutions for improved child development that can be disseminated in the long-term Thus the interventions development implementation and evaluation are framed within a realist RCT approach The intervention model is further framed within a socioecological model placing the kindergarten as an influential factor for childrens health and development

The intervention has two levels the kindergarten level and the child level In response to the challenge of low staff qualifications in general and to implement physical activity specifically the main component will be an 18-month professional development offered to kindergarten staff The intervention is structured as a 15-credit continuing education module that provide staff the opportunity to achieve credits for their efforts optional The study is based on the logic model that this professional development will change kindergarten pedagogical practices which in turn will increase and improve childrens opportunities for movement play and exploration and lead to positive child developmental effects Thus the main aim of the professional development is to provide kindergarten staff the necessary expertise and resources to intervene on the child level Researchers will not directly take part in the delivery of the intervention on the child level The intervention at the child level is derived from hypotheses theory and evidence relating to the beneficial effects of movement play and exploration on childrens physical socio-emotional and cognitive development By developing the move-play-explore nexus the project is transdisciplinary in trying in overcome boundaries between public health early years pedagogy and movement sciences The intervention will be delivered by the kindergarten staff through the use of a wide specter of types of activities and play from child-initiated and directed free-play at the one end to guided play and structured teacher-led activities at the other end

The study will be conducted from August 2024 to June 2026 for which the intervention is adjusted based on a pilot study conducted 2023-2024 Data collection will be performed at baseline all outcomes 7-month follow-up selected outcomes and 18-month follow-up all outcomes In addition process evaluation measures will be taken throughout the study Derived from a conservative sample size calculation using standard formulas including correction for the cluster RCT design we aim to recruit a minimum of 50 kindergartens and 500 children to the study This sample size will allow for uncovering statistical significant standardized effect sizes Cohens d of 025-040

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