- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06488508
Move-play-explore in Early Childhood Education (MoveEarly)
Study Overview
Status
Intervention / Treatment
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 development/continuing 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:
- How does the MoveEarly intervention impact children's movement competence, creativity, physical activity, physical fitness, playfulness, explorative behaviour, socio-emotional health, well-being, self-regulation, and early academic learning?
- 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 kindergarten's 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 intervention's 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 children's 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 children's 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 children's 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 (Cohen's d) of 0.25-0.40.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bergen, Norway, 5020
- Western Norway University of Applied Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled in a participating kindergarten
- Born in 2020
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Kindergarten staff will participate in 60 hours of professional development over 18 months focused on promotion of movement, play and exploration in the kindergarten setting.
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The intervention has two levels: the kindergarten level and the child level.
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No Intervention: Control
Staff receive no professional development and children will receive standard care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement competence and creativity
Time Frame: Change to 18 months
|
The Test of Movement Competence and Creativity, consists of 3 standardized, multi-item movement challenges children will solve as successful or not.
Measured as scores.
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Change to 18 months
|
|
Movement competence and creativity
Time Frame: Change to 7 months
|
The Test of Movement Competence and Creativity, consists of 3 standardized, multi-item movement challenges children will solve as successful or not.
Measured as scores.
|
Change to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity and sedentary time
Time Frame: Change to 18 months
|
7-day monitoring Actigraph GT3X+.
Measured in average cpm and min/day in intensity zones.
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Change to 18 months
|
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Physical activity and sedentary time
Time Frame: Change to 7 months
|
7-day monitoring Actigraph GT3X+.
Measured in average cpm and min/day in intensity zones.
|
Change to 7 months
|
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Standing long-jump
Time Frame: Change to 18 months
|
PREFIT test battery, measured in meters.
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Change to 18 months
|
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Grip strength
Time Frame: Change to 18 months
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PREFIT test battery, measured in kg.
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Change to 18 months
|
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Supine timed up and go
Time Frame: Change to 18 months
|
SUNRISE test battery, measured in seconds.
|
Change to 18 months
|
|
Body mass
Time Frame: Change to 18 months
|
Measured in kg.
|
Change to 18 months
|
|
Body mass index
Time Frame: Change to 18 months
|
Measured i kg/meter2.
|
Change to 18 months
|
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Children's social-emotional health
Time Frame: Change to 18 months
|
The Strength and Difficulties Questionnaire, staff-report on 25 items.
Measured as scores.
|
Change to 18 months
|
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Behavioural self-regulation
Time Frame: Change to 18 months
|
Head-Toes-Knees-Shoulders task (HTKS).
Measured as scores.
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Change to 18 months
|
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Numeracy
Time Frame: Change to 18 months
|
Early Years Toolbox Numbers task.
Measured as scores.
|
Change to 18 months
|
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Vocabulary
Time Frame: Change to 18 months
|
Early Years Toolbox Vocabulary task.
Measured as scores.
|
Change to 18 months
|
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Playfulness, explorative behaviour and wellbeing
Time Frame: Change to 18 months
|
The Children's Involvement and Wellbeing in Movement, Play and Exploration Questionnaire, staff-report on 21 items.
Measured as scores
|
Change to 18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eivind Aadland, PhD, Western Norway University of Applied Sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MoveEarly
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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