- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315009
Active Fundament - Fundamentally Better (AF)
An Active Fundament, Fundamentally Better: From an Early Age, Moving Well and Moving Enough as the Basis for a Lifetime of Physical Activity.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jasper de Graef, Master of Arts
- Phone Number: +31623635013
- Email: j.degraef@fontys.nl
Study Contact Backup
- Name: Dave van Kann, PhD
- Phone Number: +31627349611
- Email: d.vankann@fontys.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6211 LK
- Recruiting
- Maastricht University
-
Contact:
- Jessica Gubbels, Associate Professor
- Phone Number: +31 6 36501281
- Email: jessica.gubbels@maastrichtuniversity.nl
-
-
North Brabant
-
Eindhoven, North Brabant, Netherlands, 5644HZ
- Recruiting
- Fontys Sport en Bewegen
-
Contact:
- Dave van Kann, PhD
- Phone Number: +31 6 27349611
- Email: d.vankann@fontys.nl
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1067SM
- Recruiting
- Hogeschool van Amsterdam
-
Contact:
- Mirka Janssen, PhD
- Phone Number: +31 6 21158173
- Email: m.janssen@hva.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Childeren in ECEC settings
2-6 year olds
|
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.
|
|
Experimental: Professionals in ECEC settings
Pedagogical and educational staff including management
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
Time Frame: Assessed at baseline, mid-intervention, and at study completion (approximately 3 years)
|
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
Time Frame: Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 will be assessed using the Athletic Skills Track (AST), a standardized motor competence assessment for children.
The AST consists of a sequence of age-appropriate motor tasks assessing balance, coordination, agility, jumping, and running skills.
Performance is expressed as total completion time in seconds, with lower times indicating better motor skill performance.
Only children aged 4 years and older will be assessed.
|
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)
|
Motor competence will be assessed using the 4 Skills Scan (4SS) test, a validated motor skill assessment for children.
The 4SS evaluates four motor domains: jumping force, jumping coordination, running coordination, and object control.
Each domain is scored on a standardized scale, resulting in a total score ranging from 4 to 16, with higher scores indicating better motor skill proficiency.
Only children aged 4 years and older will be assessed.
|
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)
|
Parental involvement will be assessed using a structured parent questionnaire.
The questionnaire measures parental involvement across multiple domains, including involvement in the child center, support for the child's physical activity, and perceived child well-being.
Domain-specific mean scores will be calculated, with higher scores indicating greater parental involvement and support.
The questionnaire will be administered to parents of participating children.
|
Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)
|
Collaborators and Investigators
Investigators
- Study Director: Dave van Kann, PhD, Fontys University of Applied Sciences
- Study Director: Jessica Gubbels, Associate Professor, Maastricht University
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FHML-REC/2024/032
- RAAK.PRO05.034 (Other Grant/Funding Number: Nation agency of applied research (Regieorgaan SIA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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