Physical ActivityNCT06592391
A Study on an Educational Tool for the Development of a Tailored Dynamic School Day in Dutch Primary Schools.
A study testing educational innovation dynamic school day, e-learning on a dynamic school day and expert schools in people with Physical Activity and Children, Only, run by Amsterdam University of Applied Sciences.
Trial summary
A dynamic school day is a school day that involves regular interruptions of sedentary learning with moments of physical activity. Many Dutch primary schools have thus far not succeeded in making their school day more 'dynamic' . Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Children, Only
- What is being tested?
- educational innovation dynamic school day, e-learning on a dynamic school day and expert schools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jan 2028
- 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 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- From participating 21 schools:
- all teachers
- a board member
- all pupils from grade 4 - 8 (Dutch system, age 8 - 12)
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Process Evaluation and Effectiveness Trial to Assess a Tailored Whole School Approach for a More Dynamic School Day in Dutch Primary Schools.
A dynamic school day is a school day that involves regular interruptions of sedentary learning with moments of physical activity. Many Dutch primary schools have thus far not succeeded in making their school day more 'dynamic' .
In this project, the researchers will develop an educational innovation to support schools in the development of a dynamic school day that is tailored to their local context. To determine the effectiveness of the educational innovation, the researchers will study the implementation process and assess the effectiveness.
Read more
The research questions for the researcher project are:
- To what extend are school teams successful in the development and implementation of a tailored dynamic school day, and what are facilitating and hindering factors during implementation?
- What is the effect of the tailored dynamic school day on 8 - 12 year old pupils? Sedentary time and physical activity behavior, wellbeing and in class behavior will be assessed.
Read the detailed description
Within this project, the researchers will develop an educational innovation to support Dutch primary schools in the development of a tailored dynamic school day. To asses the effectiveness we will conduct a hybrid effect- implementation trial. The researchers will therefore conduct a process evaluation and an effectiveness trial.
The research questions for the researcher project are:
- To what extend are school teams successful in the development and implementation of a tailored dynamic school day, and what are facilitating and hindering factors during implementation?
- What is the effect of the tailored dynamic school day on 8 - 12 year old pupils? Sedentary time and physical activity behavior, wellbeing and in class behavior will be assessed.
Study sample:
A total of 21 schools will be invited to participate in this study. Three schools have already successfully implemented a dynamic school day in their local context on their own initiative. Those schools are called \'expert schools\'. The other 18 schools (6 located in Amsterdam, 6 located in Eindhoven, 6 located in Groningen) have not structurally implemented a dynamic school day. These 18 schools will be divided over 2 cohorts that will start developing their tailored dynamic school day over the course of the project.
Cohort 1 (12 schools, evenly divided over the 3 regions) will start in September 2024 with an educational program that will support them during the development of a tailored dynamic school day. They will use a full school year to develop an implementation plan, and will start the implementation of their tailored dynamic school day from September 2025 onwards. The results of the process evaluation and effectiveness trial will be used to improve the educational innovation and develop an e-learning module.
Cohort 2 (6 schools, evenly divided over the 3 regions) will start in September 2025 with the development of their tailored dynamic school day using the e-learning module. They will also use a full school year to develop an implementation plan and start implementing from September 2026 onwards.
The process evaluation and effect assessment will be conducted in all participating schools. In the development year, a baseline measurement will be conducted in autumn. All other measurements, including the baseline measurement for the expert schools, will be conducted in the spring of each year.
- Conditions
- Physical Activity, Children, Only
- Being tested
- educational innovation dynamic school day, e-learning on a dynamic school day, expert schools
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational innovation dynamic school dayOther
Schools will form a community of practice, and will be supported with regular workshop to develop a dynamic school day that matches the local context.
e-learning on a dynamic school dayOther
Schools will form a community of practice, and will develop a dynamic school day that matches their local context using e-learning materials
expert schoolsOther
Schools that have developed a local dynamic school day without additional support
| Study group | Role | What they receive |
|---|---|---|
| expert schools | Other | These schools developed their own dynamic school day over the past 5 - 10 years without using the educational innovation. Receives: Other: expert schools |
| Cohort 1 | Experimental | These schools will start the development of a tailored dynamic school day using the educational innovation in September 2024. The educational component consists of a number of face-to-face meetings. The implementation of the local plans will start September 2025. Receives: Other: educational innovation dynamic school day |
| Cohort 2 | Experimental | these schools will start the development of a tailored dynamic school day using the e-learning version of the educational innovation in September 2025. The implementation of the local plans will start September 2026. Receives: Other: e-learning on a dynamic school day |
What is being measured
The primary outcome is the main question the study is designed to answer.
process evaluation - questionnaire
Questionnaire on experiences with the implementation of the dynamic school day
Measured: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Process evaluation - semi structured interview
Semi structured interview on school policy focussed on aspects that are related to a dynamic school day
Measured: 1 time per year until the end of the study (spring school year) which is 2 or 3 years depending on the cohort
Process evaluation - observations within the school
Observations within 2 classrooms to assess physical activity behavior during the school day
Measured: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Process evaluation - analysis of teaching schedules
Teacher schedules and overview of minutes of physical activity during the schoolday to assess how many active minutes are reached.
Measured: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Secondary outcomes (3)
effect evaluation - wellbeing pupils
wellbeing questionnaire completed by parent of 8-12 year old pupils
Measured: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
effect evaluation - on-task behavior
observation within two class rooms to count the number of pupils that show on-task behavior (measured on Tuesday and Thursday)
Measured: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
effect evaluation - physical activity behavior
Pupils will wear an accelerometer on their hip during 5 days: Monday morning - Friday afternoon
Measured: During the year of development (1st year of participation) 2 weeks (fall + spring school year). After that one week per year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hanze University of Applied Sciences Groningen, Fontys University of Applied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592391
- Sponsor's protocol ID
- HVA-271
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process Evaluation and Effectiveness Trial to Assess a Tailored Whole School Approach for a More Dynamic School Day in Dutch Primary Schools.
- ClinicalTrials.gov ID
- NCT06592391
- Acronym / sponsor ID
- HVA-271
- Conditions
- Physical Activity, Children, Only
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- Amsterdam University of Applied SciencesUniversity, hospital or other
- Collaborators
- Hanze University of Applied Sciences Groningen, Fontys University of Applied Sciences
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
A dynamic school day is a school day that involves regular interruptions of sedentary learning with moments of physical activity. Many Dutch primary schools have thus far not succeeded in making their school day more 'dynamic' .
In this project, the researchers will develop an educational innovation to support schools in the development of a dynamic school day that is tailored to their local context. To determine the effectiveness of the educational innovation, the researchers will study the implementation process and assess the effectiveness.
The research questions for the researcher project are:
- To what extend are school teams successful in the development and implementation of a tailored dynamic school day, and what are facilitating and hindering factors during implementation?
- What is the effect of the tailored dynamic school day on 8 - 12 year old pupils? Sedentary time and physical activity behavior, wellbeing and in class behavior will be assessed.
Detailed description
Within this project, the researchers will develop an educational innovation to support Dutch primary schools in the development of a tailored dynamic school day. To asses the effectiveness we will conduct a hybrid effect- implementation trial. The researchers will therefore conduct a process evaluation and an effectiveness trial.
The research questions for the researcher project are:
- To what extend are school teams successful in the development and implementation of a tailored dynamic school day, and what are facilitating and hindering factors during implementation?
- What is the effect of the tailored dynamic school day on 8 - 12 year old pupils? Sedentary time and physical activity behavior, wellbeing and in class behavior will be assessed.
Study sample:
A total of 21 schools will be invited to participate in this study. Three schools have already successfully implemented a dynamic school day in their local context on their own initiative. Those schools are called \'expert schools\'. The other 18 schools (6 located in Amsterdam, 6 located in Eindhoven, 6 located in Groningen) have not structurally implemented a dynamic school day. These 18 schools will be divided over 2 cohorts that will start developing their tailored dynamic school day over the course of the project.
Cohort 1 (12 schools, evenly divided over the 3 regions) will start in September 2024 with an educational program that will support them during the development of a tailored dynamic school day. They will use a full school year to develop an implementation plan, and will start the implementation of their tailored dynamic school day from September 2025 onwards. The results of the process evaluation and effectiveness trial will be used to improve the educational innovation and develop an e-learning module.
Cohort 2 (6 schools, evenly divided over the 3 regions) will start in September 2025 with the development of their tailored dynamic school day using the e-learning module. They will also use a full school year to develop an implementation plan and start implementing from September 2026 onwards.
The process evaluation and effect assessment will be conducted in all participating schools. In the development year, a baseline measurement will be conducted in autumn. All other measurements, including the baseline measurement for the expert schools, will be conducted in the spring of each year.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| expert schools | Other | Other: expert schoolsThese schools developed their own dynamic school day over the past 5 - 10 years without using the educational innovation. |
| Cohort 1 | Experimental | Other: educational innovation dynamic school dayThese schools will start the development of a tailored dynamic school day using the educational innovation in September 2024. The educational component consists of a number of face-to-face meetings. The implementation of the local plans will start September 2025. |
| Cohort 2 | Experimental | Other: e-learning on a dynamic school daythese schools will start the development of a tailored dynamic school day using the e-learning version of the educational innovation in September 2025. The implementation of the local plans will start September 2026. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- all teachers
- a board member
- all pupils from grade 4 - 8 (Dutch system, age 8 - 12)
Key exclusion criteria (1 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 |
|---|---|---|
| educational innovation dynamic school daySchools will form a community of practice, and will be supported with regular workshop to develop a dynamic school day that matches the local context. | Other | Cohort 1 |
| e-learning on a dynamic school daySchools will form a community of practice, and will develop a dynamic school day that matches their local context using e-learning materials | Other | Cohort 2 |
| expert schoolsSchools that have developed a local dynamic school day without additional support | Other | expert schools |
Primary outcome
process evaluation - questionnaire
Time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Questionnaire on experiences with the implementation of the dynamic school day
Process evaluation - semi structured interview
Time frame: 1 time per year until the end of the study (spring school year) which is 2 or 3 years depending on the cohort
Semi structured interview on school policy focussed on aspects that are related to a dynamic school day
Process evaluation - observations within the school
Time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Observations within 2 classrooms to assess physical activity behavior during the school day
Process evaluation - analysis of teaching schedules
Time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
Teacher schedules and overview of minutes of physical activity during the schoolday to assess how many active minutes are reached.
3 secondary outcomes
effect evaluation - wellbeing pupils
Time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
effect evaluation - on-task behavior
Time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
effect evaluation - physical activity behavior
Time frame: During the year of development (1st year of participation) 2 weeks (fall + spring school year). After that one week per year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.
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 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing educational innovation dynamic school day, e-learning on a dynamic school day and expert schools in people with Physical Activity and Children, Only, run by Amsterdam University of Applied Sciences.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Anne de Jong (+31 648275920, a.s.de.jong@hva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
process evaluation - questionnaire (time frame: During the year of development (1st year of participation) 2 times (fall + spring school year). After that once a year (spring school year) until the end of the study which may be 2 or 3 years depending on the cohort.). The study lists 4 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 19 Sep 2024.