Kindergarten Children's Health, Development, Well-beingMoveEarlyNCT06488508
Move-play-explore in Early Childhood Education
A study testing MoveEarly in people with Kindergarten Children's Health, Development, Well-being, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 4 years
- Conditions the study is for
- Kindergarten Children's Health, Development, Well-being
- What is being tested?
- MoveEarly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 19 Aug 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in a participating kindergarten
- Born in 2020
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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. Children's 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.
Read the 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.
- Being tested
- MoveEarly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoveEarlyBehavioural
The intervention has two levels: the kindergarten level and the child level.
- Staff will receive approximately 60 hours of professional development, including 6 full-day physical seminars, 2 full-day kindergarten visits, 6 written tasks with follow-up webinars and an online resource. The focus will be how to promote movement, play and exploration among children aged 1-6 years.
- Staff is supposed to promote children's movement, play and exploration through 7 pedagogical principles: 1. Value, understand and promote movement, 2. Value, understand and promote play, 3. Value, understand and promote exploration, 4. Create rich physical environments, 5. Create opportunities for meaningful participation, 6. Create good balance between challenge and support, and 7. Create good dialogue through action and words.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: MoveEarly |
| Control | No intervention | Staff receive no professional development and children will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement competence and creativity
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.
Measured: Change to 18 months
Movement competence and creativity
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.
Measured: Change to 7 months
Secondary outcomes (12)
Physical activity and sedentary time
7-day monitoring Actigraph GT3X+. Measured in average cpm and min/day in intensity zones.
Measured: Change to 18 months
Physical activity and sedentary time
7-day monitoring Actigraph GT3X+. Measured in average cpm and min/day in intensity zones.
Measured: Change to 7 months
Standing long-jump
PREFIT test battery, measured in meters.
Measured: Change to 18 months
Grip strength
PREFIT test battery, measured in kg.
Measured: Change to 18 months
Supine timed up and go
SUNRISE test battery, measured in seconds.
Measured: Change to 18 months
Body mass
Measured in kg.
Measured: Change to 18 months
Body mass index
Measured i kg/meter2.
Measured: Change to 18 months
Children's social-emotional health
The Strength and Difficulties Questionnaire, staff-report on 25 items. Measured as scores.
Measured: Change to 18 months
Behavioural self-regulation
Head-Toes-Knees-Shoulders task (HTKS). Measured as scores.
Measured: Change to 18 months
Numeracy
Early Years Toolbox Numbers task. Measured as scores.
Measured: Change to 18 months
Vocabulary
Early Years Toolbox Vocabulary task. Measured as scores.
Measured: Change to 18 months
Playfulness, explorative behaviour and wellbeing
The Children's Involvement and Wellbeing in Movement, Play and Exploration Questionnaire, staff-report on 21 items. Measured as scores
Measured: Change to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start19 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kindergarten Children's Health, Development, Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization of 25 kindergartens to the intervention group (professional development) and 25 kindergartens to the control group (standard of care)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eivind Aadland, Western Norway University of Applied Sciences
- Investigators
- Eivind Aadland, PhD, Principal investigator, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488508
- Sponsor's protocol ID
- MoveEarly
- Acronym
- MoveEarly
- Status last verified
- Mar 2025
- First submitted
- 21 Jun 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared on reasonable request
Publications
Aadland E, Sadownik AR, Rudd J, Tjomsland HE, Okely AD, Eriksen PB, Grindheim M, Joyce T, Tveten K, Varnes TK, Johannessen K, Aadland KN, Odegaard EE. Move-play-explore in early childhood education (MoveEarly) - study protocol of a cluster randomized controlled trial of staff professional development for quality pedagogical practices and holistic child development in Norwegian kindergartens. BMC Public Health. 2025 Dec 10;26(1):546. doi: 10.1186/s12889-025-25831-1.
PubMed 41372827
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move-play-explore in Early Childhood Education
- ClinicalTrials.gov ID
- NCT06488508
- Acronym / sponsor ID
- MoveEarly / MoveEarly
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Children's 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomization of 25 kindergartens to the intervention group (professional development) and 25 kindergartens to the control group (standard of care)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MoveEarlyKindergarten staff will participate in 60 hours of professional development over 18 months focused on promotion of movement, play and exploration in the kindergarten setting. |
| Control | No intervention | –Staff receive no professional development and children will receive standard care. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in a participating kindergarten
- Born in 2020
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoveEarlyThe intervention has two levels: the kindergarten level and the child level. 1. Staff will receive approximately 60 hours of professional development, including 6 full-day physical seminars, 2 full-day kindergarten visits, 6 written tasks with follow-up webinars and an online resource. The focus will be how to promote movement, play and exploration among children aged 1-6 years. 2. Staff is supposed to promote children's movement, play and exploration through 7 pedagogical principles: 1. Value, understand and promote movement, 2. Value, understand and promote play, 3. Value, understand and promote exploration, 4. Create rich physical environments, 5. Create opportunities for meaningful participation, 6. Create good balance between challenge and support, and 7. Create good dialogue through action and words. | Behavioural | Intervention |
Primary outcome
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.
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.
12 secondary outcomes
Physical activity and sedentary time
Time frame: Change to 18 months
Physical activity and sedentary time
Time frame: Change to 7 months
Standing long-jump
Time frame: Change to 18 months
Grip strength
Time frame: Change to 18 months
Supine timed up and go
Time frame: Change to 18 months
Body mass
Time frame: Change to 18 months
Body mass index
Time frame: Change to 18 months
Children's social-emotional health
Time frame: Change to 18 months
Behavioural self-regulation
Time frame: Change to 18 months
Numeracy
Time frame: Change to 18 months
Vocabulary
Time frame: Change to 18 months
Playfulness, explorative behaviour and wellbeing
Time frame: Change to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41372827Aadland E, Sadownik AR, Rudd J, Tjomsland HE, Okely AD, Eriksen PB, Grindheim M, Joyce T, Tveten K, Varnes TK, Johannessen K, Aadland KN, Odegaard EE. Move-play-explore in early childhood education (MoveEarly) - study protocol of a cluster randomized controlled trial of staff professional development for quality pedagogical practices and holistic child development in Norwegian kindergartens. BMC Public Health. 2025 Dec 10;26(1):546. doi: 10.1186/s12889-025-25831-1.
- Project web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data may be shared on reasonable request
Related trials for Kindergarten Children's Health, Development, Well-being
Active, not recruiting
The Ready and Healthy for Kindergarten Study
Parenting, Language Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eivind Aadland, PhD principal investigator
Western Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoveEarly in people with Kindergarten Children's Health, Development, Well-being, run by Western Norway University of Applied Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement competence and creativity (time frame: Change to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.