NCT07315009

Brief Summary

The objective of this longitudinal, quasi-experimental study is to improve children's fundamental motor skills and physical activity levels. In addition, the study aims to support pedagogical staff and educators in implementing physical activity during the workday, with the intention of facilitating a more supportive and enjoyable working environment that aligns with children's needs for physical activity. The study is conducted in 18 child centers, combining childcare and preschool settings. Participants include children aged 2-6 years and their pedagogical staff and teachers. The primary research questions addressed are:

  • Can pedagogical staff and teachers be supported in increasing physical activity levels among children aged 2-6 years?
  • Can a scalable intervention for child centers be developed that can be implemented in other regions following completion of the study? A total of nine intervention centers will be compared with nine control centers to determine whether observed effects can be attributed to the intervention. Children will participate in assessments of motor skills, wear accelerometers to measure physical activity levels, and take part in walk-along interviews and a draw-and-tell method. Parents will complete questionnaires. Pedagogical staff and teachers will complete questionnaires and participate in observational assessments. Management representatives of the child centers (both preschool and childcare) will participate in interviews and complete a questionnaire to construct an echogram.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

December 4, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Child centerphysical activity levelspreschoolchildcaremotor skills

Outcome Measures

Primary Outcomes (3)

  • Average daily light physical activity, moderate-to-vigorous physical activity (MVPA), and sedentary behavior in minutes, assessed by accelerometry

    Children's physical activity behavior will be objectively assessed using triaxial accelerometers (ActiGraph GT3X+). Accelerometers will be worn during waking hours for seven consecutive days. Physical activity data will be processed using validated pediatric cut-points to derive average daily time spent in light physical activity, moderate-to-vigorous physical activity (MVPA), and sedentary behavior. Outcomes will be reported as mean minutes per day for each activity intensity category per measurement period.

    One week of accelerometer measurement, repeated annually in the spring season for four consecutive years

  • Pedagogical support for physical activity assessed by the Movement Environment Rating Scale (MOVERS)

    Pedagogical actions of teachers and caretakers that support children's physical activity will be assessed using the Movement Environment Rating Scale (MOVERS). MOVERS is an observational instrument designed for early childhood education and care settings and evaluates the extent to which pedagogical practices and environmental characteristics promote physical activity and motor development. The scale consists of four domains and yields a total score ranging from 1 to 7, with higher scores indicating a more supportive physical activity environment and higher-quality pedagogical practices. Observations will be conducted during a full day in childcare and preschool settings by trained observers.

    Assessed at baseline, mid-intervention, and at study completion (approximately 3 years)

  • Self-reported pedagogical physical activity practices assessed by questionnaire

    Pedagogical staff's self-reported practices related to promoting physical activity and fundamental motor skills will be assessed using a structured questionnaire. The questionnaire captures frequency and type of physical activity-related pedagogical actions during the workday. Outcomes will be summarized as mean scores per domain, with higher scores indicating greater engagement in physical activity-supportive practices.

    Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)

Secondary Outcomes (3)

  • Motor competence assessed by the Athletic Skills Track (AST)

    Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)

  • Motor competence assessed by the 4 Skills Scan (4SS) test

    Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)

  • Parental involvement in the child center and child physical activity assessed by questionnaire

    Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)

Study Arms (2)

Childeren in ECEC settings

EXPERIMENTAL

2-6 year olds

Behavioral: Actief Fundament

Professionals in ECEC settings

EXPERIMENTAL

Pedagogical and educational staff including management

Behavioral: Actief Fundament

Interventions

In procesmeetings with the intervention centers we will discuss possible changes to improve physical activity levels of children. Activities and changes will be based on the measurement outcomes.

Childeren in ECEC settingsProfessionals in ECEC settings

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children must be in the child center in the recruitment period(s)
  • Professionals in ECEC and management must be working at the child center during the recruitment period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maastricht University

Maastricht, Limburg, 6211 LK, Netherlands

RECRUITING

Fontys Sport en Bewegen

Eindhoven, North Brabant, 5644HZ, Netherlands

RECRUITING

Hogeschool van Amsterdam

Amsterdam, North Holland, 1067SM, Netherlands

RECRUITING

Related Links

Study Officials

  • Dave van Kann, PhD

    Fontys University of Applied Sciences

    STUDY DIRECTOR
  • Jessica Gubbels, Associate Professor

    Maastricht University

    STUDY DIRECTOR

Central Study Contacts

Jasper de Graef, Master of Arts

CONTACT

Dave van Kann, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Longitudinal, Quasi-experimental.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher-researcher (PhD Candidate)

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 2, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations