Physical Inactivity in Early Childhood and CareAFNCT07315009
Active Fundament - Fundamentally Better
A study testing Actief Fundament in people with Physical Inactivity in Early Childhood and Care and Delayed Fundamental Motor Skill Development, run by Fontys University of Applied Sciences at 3 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity in Early Childhood and Care, Delayed Fundamental Motor Skill Development, Early Childhood & Care Physical Activity Behavior
- What is being tested?
- Actief Fundament
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Hogeschool van Amsterdam
Amsterdam, North Holland, 1067SM
Mirka Janssen, PhD, +31 6 21158173, m.janssen@hva.nl
- Recruiting
Fontys Sport en Bewegen
Eindhoven, North Brabant, 5644HZ
Dave van Kann, PhD, +31 6 27349611, d.vankann@fontys.nl
- Recruiting
Maastricht University
Maastricht, Limburg, 6211 LK
Jessica Gubbels, Associate Professor, +31 6 36501281, jessica.gubbels@maastrichtuniversity.nl
About this study
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.
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.
Read more
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.
- 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, Physical Activity-Supportive Early Childhood Education and Care (ECEC) Environment
- Being tested
- Actief Fundament
- Keywords
- Child center, physical activity levels, preschool, childcare, motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actief FundamentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Childeren in ECEC settings | Experimental | 2-6 year olds Receives: Behavioral: Actief Fundament |
| Professionals in ECEC settings | Experimental | Pedagogical and educational staff including management Receives: Behavioral: Actief Fundament |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at baseline and annually thereafter during the spring season, through study completion (up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Inactivity in Early Childhood and CareStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal, Quasi-experimental.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fontys University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper de Graef, Fontys University of Applied Sciences
- Investigators
- Dave van Kann, PhD, Study director, Fontys University of Applied SciencesJessica Gubbels, Associate Professor, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315009
- Sponsor's protocol ID
- FHML-REC/2024/032
- Other IDs
- RAAK.PRO05.034
- Acronym
- AF
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07315009
- Acronym / sponsor ID
- AF / FHML-REC/2024/032
- 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, Physical Activity-Supportive Early Childhood Education and Care (ECEC) Environment
- Keywords
- Child center, physical activity levels, preschool, childcare, motor skills
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fontys University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jan 2026 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal, Quasi-experimental.
| Arm | Type | Receives |
|---|---|---|
| Childeren in ECEC settings | Experimental | Behavioral: Actief Fundament2-6 year olds |
| Professionals in ECEC settings | Experimental | Behavioral: Actief FundamentPedagogical and educational staff including management |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Actief FundamentIn 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. | Behavioural | Childeren in ECEC settings, Professionals in ECEC settings |
Primary outcome
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.
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.
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.
3 secondary outcomes
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)
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 2 Jan 2026.
- Study project websiteLink provided by the sponsor.
- Project fundingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Dave van Kann, PhD study director
Fontys University of Applied Sciences
Jessica Gubbels, Associate Professor study director
Maastricht University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actief Fundament in people with Physical Inactivity in Early Childhood and Care and Delayed Fundamental Motor Skill Development, run by Fontys University of Applied Sciences at 3 sites in Netherlands.
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 0 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Contact Jasper de Graef, Master of Arts (+31623635013, j.degraef@fontys.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.