NCT06488508

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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2024Jun 2026

First Submitted

Initial submission to the registry

June 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

June 21, 2024

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change to 7 months

Secondary Outcomes (12)

  • Physical activity and sedentary time

    Change to 18 months

  • Physical activity and sedentary time

    Change to 7 months

  • Standing long-jump

    Change to 18 months

  • Grip strength

    Change to 18 months

  • Supine timed up and go

    Change to 18 months

  • +7 more secondary outcomes

Study Arms (2)

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.

Behavioral: MoveEarly

Control

NO INTERVENTION

Staff receive no professional development and children will receive standard care.

Interventions

MoveEarlyBEHAVIORAL

The 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.

Intervention

Eligibility Criteria

Age4 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in a participating kindergarten
  • Born in 2020

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, 5020, Norway

Location

Related Publications (1)

  • 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. doi: 10.1186/s12889-025-25831-1. Online ahead of print.

Related Links

Study Officials

  • Eivind Aadland, PhD

    Western Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomization of 25 kindergartens to the intervention group (professional development) and 25 kindergartens to the control group (standard of care)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 5, 2024

Study Start

August 19, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Data may be shared on reasonable request

Locations