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Recruiting NCT07315009

Active Fundament - Fundamentally Better

No phase Interventional Physical Inactivity in Early Childhood and Care Delayed Fundamental Motor Skill Development Early Childhood & Care Physical Activity Behavior Motor Development in Children Aged 2-6 Years

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Actief Fundament.
Who it may be relevant to
Registry conditions: Physical Inactivity in Early Childhood and Care, Delayed Fundamental Motor Skill Development, Early Childhood & Care Physical Activity Behavior, Motor Development in Children Aged 2-6 Years. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Active Fundament, Fundamentally Better: From an Early Age, Moving Well and Moving Enough as the Basis for a Lifetime of Physical Activity.

Overview

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.

Interventions

  • Behavioral Actief Fundament
    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.

Primary outcome measures

  • Average daily light physical activity, moderate-to-vigorous physical activity (MVPA), and sedentary behavior in minutes, assessed by accelerometry [Time frame: 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) [Time frame: Assessed at baseline, mid-intervention, and at study completion (approximately 3 years)]
  • Self-reported pedagogical physical activity practices assessed by questionnaire [Time frame: Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)]
Secondary outcome measures (3)
  • Motor competence assessed by the Athletic Skills Track (AST) [Time frame: 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 [Time frame: 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 [Time frame: Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)]

Eligibility criteria

Inclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Netherlands · 3 centers
  • Maastricht University — Maastricht
  • Fontys Sport en Bewegen — Eindhoven
  • Hogeschool van Amsterdam — Amsterdam

Identifiers

NCT: NCT07315009 · FHML-REC/2024/032 · RAAK.PRO05.034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗