Physical InactivityNCT05865782
Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes
A study testing Schoolyard reconstruction in people with Physical Inactivity and Environmental Exposure, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas. The overarching purpose of the proposed project is to: i. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Environmental Exposure, Mental Health Wellness 1
- What is being tested?
- Schoolyard reconstruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteSweden
- Study dates
- 22 May 2024to 30 Nov 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- On school level:
- -School selected for schoolyard reconstruction by the City of Stockholm
- On individual level (schoolchildren):
- Enrolled in participating school
- 8-13 years old at the time of study start
- In 2nd or 5th grade
- Parents signed informed consent
Who cannot join
- On school level:
- -School not selected for schoolyard reconstruction by the City of Stockholm
- On individual level (schoolchildren):
- Not enrolled in participating school
- Outside 8-13 years old age range and/or not in 2nd or 5th grade
- Parents declined informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 113 65
Daniel Berglind, Phd.
About this study
Official title: Skolgårdsprojketet: Bygga om skolgårdar i Stockholm Med grönska för Att öka Skolbarns Fysisk Aktivitet Och hälsa Samt Mildra klimatförändringarna i städer
By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas.
The overarching purpose of the proposed project is to:
- increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact
Read the detailed description
Background More than half of Swedish schoolchildren do not meet the physical activity guidelines, which will have long-lasting effects on their health in adulthood. The school environment plays a crucial role in establishing healthy physical activity behaviors for a population.
A formal decision has been made to reconstruct 15 Stockholm public schoolyards from 2024 to 2026. This project is evaluating the effects of this decision.
Project design The project is designed as a quasi-experimental stepped-wedge trial, with schools serving as both intervention and control schools. Over the course of 3 years (2023-2026), a total of 15 schoolyard reconstructions will be evaluated, with 5 reconstructions per year. The units of observation will be second and fifth grade children, totaling 2,700 children.
Methods for data collection The following primary and secondary outcomes will be measured at baseline (May) and at follow-up one year later (May the following year), in all schools, among participating children.
Research questions
- How does schoolyard reconstruction affect physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave in schoolchildren?
- Which components of schoolyard reconstruction are associated with changes (if any) in physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave in schoolchildren?
- What would be the cost-effectiveness of schoolyard reconstruction on the health outcomes, physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave of school children, as well as its impact on the microclimate and CO2-emissions in urban areas, if the project would be extended to other schools in Stockholm, and possibly Sweden as a whole?
Intervention description and theory The schoolyard reconstruction process will use a participatory bottom-up co-creation development approach involving students, school personnel and researchers and will be evidence-based, using prior knowledge on schoolyard features that are associated with children's physical activity during school-hours. Additionally, the schoolyard reconstruction intervention process will be discussed and acknowledged among all co-creators to increase the engagement, buy-in, feasibility, relevance and sustainability of the schoolyard reconstruction intervention.
Workshops will be held by experts from the City of Stockholm, Karolinska institutet and landscape architects with greenery experience, students, school personnel (e.g., principal, teachers etc.), at each school before schoolyard reconstruction initiation. The workshops will process the design and dimension of what components the schoolyard reconstruction should encompass, reflecting school personnel/students' proposals and local challenges and needs.
Statistical analyses Each school undertaking schoolyard renewal will be treated as an independent unit and analyzed separately (i.e., analyses of five separate schoolyard renewals, with appurtenant intervention school, per year). We will match each intervention school, based on school size and socioeconomic factors, with a control school undertaking schoolyard renewal at a different time-point. We deem it appropriate to analyze each control-intervention pair separately as each intervention school represent a unique schoolyard renewal intervention package (different reconstructions). We will also pool the pair-specific estimates, as appropriate, to quantify a global estimate of the total effect of the project.
Societal relevance Most schoolyards in Stockholm lack appealing play areas and are instead dominated by concrete and asphalt surfaces. As school participation is not segregated by socioeconomic factors, schoolyard reconstructions that promote physical activity can benefit children from all socioeconomic groups. Additionally, reconstructing schoolyards with greenery can mitigate health and environmental risks associated with increasing climate changes in urban areas.
- Being tested
- Schoolyard reconstruction
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schoolyard reconstructionBehavioural
The current study will be designed as a quasi-experimental stepped-wedge intervention where schools undertaking schoolyard reconstruction will act as both control and intervention schools. By using the stepped-wedge study design, with internal control schools, will enable the control for the seasonal variation in children's physical activity levels and for the age-related decline in physical activity throughout childhood. That is, without control schools we would be unable to attribute a change in physical activity to the reconstruction of the schoolyards - as any difference in physical activity before and after the schoolyard reconstruction in the intervention group could be explained by the natural change in physical activity over time.
| Study group | Role | What they receive |
|---|---|---|
| Schoolyard reconstruction | Experimental | Schools undertaking schoolyard reconstruction will act as both control and intervention schools. Each year, a cross-sectional sample of 2nd and 5th grade children will be measured in all participating schools. Receives: Behavioral: Schoolyard reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity levels in children
Physical activity levels in terms of daily minutes in moderate to vigorous physical activity, total physical activity and daily steps measured objectively by Actigraph GT3X+ accelerometers
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in physical activity levels
Secondary outcomes (11)
Change in musculoskeletal fitness in children
Musculoskeletal fitness, in terms of handgrip strength ,will be measured by an analogue dynamometer (TKK 5825, Grip-A, Takei, Tokyo, Japan).
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in musculoskeletal fitness (handgrip strength)
Change in weight in children
Weight (in kilograms) will be measured with validated scales
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in weight
Change in height in children
Height (in centimeters) will be measured with validated stadiometers
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in height
Change in blood pressure in children
Systolic and diastolic blood pressure will be measured three times (and we will use the mean value of the two last measures), in the seated position after a five-minutes rest, using a medically approved automatic digital blood pressure monitor
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in blood pressure
Change in mental health in children
Psychosocial functioning of children will be assessed by a parental proxy report of the Strength and Difficulty Questionnaire. Total difficulties score is generated by summing scores from all the scales except the prosocial scale and ranges from 0 to 40, higher score means worse outcome
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in mental health
Change in sleep in children
Sleep will be measured objectively by the GT3X+ accelerometer. In addition, parents will answer questions about children's sleep duration and quality in the last 6 months in the sleep questionnaire. These sleep questions are adapted from the validated Ages and Stages Questionnaire. The sleep quality score ranges from 0-12 and higher score means better outcome
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sleep
Change in sick leave
Sick leave frequency and duration (occasions and days) will be collected from a Stockholm City database
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sick leave
Change in children's perception of the schoolyard quality
A questionnaire with 7 items, previously used to evaluate schoolyard reconstructions, will be used to assess children's perception of the schoolyard quality
Measured: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in children's perception of the schoolyard quality
Schoolyard reconstruction costs
Detailed budget costs for each schoolyard reconstruction, e.g., play equipment, construction and maintenance costs will be collected for each separate schoolyard reconstruction and further used for health economic evaluations
Measured: Collected through study completion, an average of 1 year
Environmental impact of schoolyard reconstruction
Based on greenery increase from the schoolyard reconstruction we will use models for impact on CO2-emissions and albedo (Δα) scores (i.e., reflective properties from greenery) as environmental benefit outcomes
Measured: Collected through study completion, an average of 1 year
Incidents in the schoolyard
Number of incidents (e.g., conflicts, sun burns etc.) from before to after schoolyard reconstruction
Measured: Change in number of incidents from 12 months before to 12 months after schoolyard reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start22 May 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Study design The current study will be designed as a quasi-experimental stepped-wedge intervention where schools undertaking schoolyard reconstruction will act as both control and intervention schools. Five schools will yearly receive the intervention (schoolyard reconstruction) at 4 different time points (during the summer breaks in 2023, 2024, 2025 and 2026) and the schools not receiving the intervention the specific year will act as control schools. The units where the proposed outcomes will be observed will be 2nd and 5th grade children (individual level) in the participating schools. Each year, a cross-sectional sample of 2nd and 5th grade children will be measured in all participating schools.
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The City of Stockholm, Cancerfonden, Arwidssonstiftelsen
- Responsible party
- Principal investigator, Daniel Berglind, Karolinska Institutet
- Investigators
- Daniel Berglind, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865782
- Sponsor's protocol ID
- The Schoolyard project
- Status last verified
- May 2024
- First submitted
- 29 Mar 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Swedish law do not allow individual data sharing without ethical permission.
Publications
Wilen C, Ahlqvist VH, Migueles JH, Campos-Garzon P, Dahlen M, Kosidou K, Radholm K, Henriksson P, Berglind D. Reconstructing schoolyards with greenery to increase schoolchildren's physical activity and mitigate climate changes in urban areas: study protocol for a stepped-wedge trial. BMC Public Health. 2026 Feb 17;26(1):708. doi: 10.1186/s12889-026-26609-9.
PubMed 41699610
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skolgårdsprojketet: Bygga om skolgårdar i Stockholm Med grönska för Att öka Skolbarns Fysisk Aktivitet Och hälsa Samt Mildra klimatförändringarna i städer
- ClinicalTrials.gov ID
- NCT05865782
- Acronym / sponsor ID
- The Schoolyard project
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The City of Stockholm, Cancerfonden, Arwidssonstiftelsen
- Study start
- 22 May 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 19 May 2023 (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.
By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas.
The overarching purpose of the proposed project is to:
- increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact
Detailed description
Background More than half of Swedish schoolchildren do not meet the physical activity guidelines, which will have long-lasting effects on their health in adulthood. The school environment plays a crucial role in establishing healthy physical activity behaviors for a population.
A formal decision has been made to reconstruct 15 Stockholm public schoolyards from 2024 to 2026. This project is evaluating the effects of this decision.
Project design The project is designed as a quasi-experimental stepped-wedge trial, with schools serving as both intervention and control schools. Over the course of 3 years (2023-2026), a total of 15 schoolyard reconstructions will be evaluated, with 5 reconstructions per year. The units of observation will be second and fifth grade children, totaling 2,700 children.
Methods for data collection The following primary and secondary outcomes will be measured at baseline (May) and at follow-up one year later (May the following year), in all schools, among participating children.
Research questions
- How does schoolyard reconstruction affect physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave in schoolchildren?
- Which components of schoolyard reconstruction are associated with changes (if any) in physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave in schoolchildren?
- What would be the cost-effectiveness of schoolyard reconstruction on the health outcomes, physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave of school children, as well as its impact on the microclimate and CO2-emissions in urban areas, if the project would be extended to other schools in Stockholm, and possibly Sweden as a whole?
Intervention description and theory The schoolyard reconstruction process will use a participatory bottom-up co-creation development approach involving students, school personnel and researchers and will be evidence-based, using prior knowledge on schoolyard features that are associated with children's physical activity during school-hours. Additionally, the schoolyard reconstruction intervention process will be discussed and acknowledged among all co-creators to increase the engagement, buy-in, feasibility, relevance and sustainability of the schoolyard reconstruction intervention.
Workshops will be held by experts from the City of Stockholm, Karolinska institutet and landscape architects with greenery experience, students, school personnel (e.g., principal, teachers etc.), at each school before schoolyard reconstruction initiation. The workshops will process the design and dimension of what components the schoolyard reconstruction should encompass, reflecting school personnel/students' proposals and local challenges and needs.
Statistical analyses Each school undertaking schoolyard renewal will be treated as an independent unit and analyzed separately (i.e., analyses of five separate schoolyard renewals, with appurtenant intervention school, per year). We will match each intervention school, based on school size and socioeconomic factors, with a control school undertaking schoolyard renewal at a different time-point. We deem it appropriate to analyze each control-intervention pair separately as each intervention school represent a unique schoolyard renewal intervention package (different reconstructions). We will also pool the pair-specific estimates, as appropriate, to quantify a global estimate of the total effect of the project.
Societal relevance Most schoolyards in Stockholm lack appealing play areas and are instead dominated by concrete and asphalt surfaces. As school participation is not segregated by socioeconomic factors, schoolyard reconstructions that promote physical activity can benefit children from all socioeconomic groups. Additionally, reconstructing schoolyards with greenery can mitigate health and environmental risks associated with increasing climate changes in urban areas.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study design The current study will be designed as a quasi-experimental stepped-wedge intervention where schools undertaking schoolyard reconstruction will act as both control and intervention schools. Five schools will yearly receive the intervention (schoolyard reconstruction) at 4 different time points (during the summer breaks in 2023, 2024, 2025 and 2026) and the schools not receiving the intervention the specific year will act as control schools. The units where the proposed outcomes will be observed will be 2nd and 5th grade children (individual level) in the participating schools. Each year, a cross-sectional sample of 2nd and 5th grade children will be measured in all participating schools.
| Arm | Type | Receives |
|---|---|---|
| Schoolyard reconstruction | Experimental | Behavioral: Schoolyard reconstructionSchools undertaking schoolyard reconstruction will act as both control and intervention schools. Each year, a cross-sectional sample of 2nd and 5th grade children will be measured in all participating schools. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- -School selected for schoolyard reconstruction by the City of Stockholm
- Enrolled in participating school
- 8-13 years old at the time of study start
- In 2nd or 5th grade
- Parents signed informed consent
Key exclusion criteria (6 listed)
- -School not selected for schoolyard reconstruction by the City of Stockholm
- Not enrolled in participating school
- Outside 8-13 years old age range and/or not in 2nd or 5th grade
- Parents declined informed consent
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 |
|---|---|---|
| Schoolyard reconstructionThe current study will be designed as a quasi-experimental stepped-wedge intervention where schools undertaking schoolyard reconstruction will act as both control and intervention schools. By using the stepped-wedge study design, with internal control schools, will enable the control for the seasonal variation in children's physical activity levels and for the age-related decline in physical activity throughout childhood. That is, without control schools we would be unable to attribute a change in physical activity to the reconstruction of the schoolyards - as any difference in physical activity before and after the schoolyard reconstruction in the intervention group could be explained by the natural change in physical activity over time. | Behavioural | Schoolyard reconstruction |
Primary outcome
Change in physical activity levels in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in physical activity levels
Physical activity levels in terms of daily minutes in moderate to vigorous physical activity, total physical activity and daily steps measured objectively by Actigraph GT3X+ accelerometers
11 secondary outcomes
Change in musculoskeletal fitness in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in musculoskeletal fitness (handgrip strength)
Change in weight in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in weight
Change in height in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in height
Change in blood pressure in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in blood pressure
Change in mental health in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in mental health
Change in sleep in children
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sleep
Change in sick leave
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sick leave
Change in children's perception of the schoolyard quality
Time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in children's perception of the schoolyard quality
Schoolyard reconstruction costs
Time frame: Collected through study completion, an average of 1 year
Environmental impact of schoolyard reconstruction
Time frame: Collected through study completion, an average of 1 year
Incidents in the schoolyard
Time frame: Change in number of incidents from 12 months before to 12 months after schoolyard reconstruction
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 20 Jun 2024.
- Derived from this study: PubMed 41699610Wilen C, Ahlqvist VH, Migueles JH, Campos-Garzon P, Dahlen M, Kosidou K, Radholm K, Henriksson P, Berglind D. Reconstructing schoolyards with greenery to increase schoolchildren's physical activity and mitigate climate changes in urban areas: study protocol for a stepped-wedge trial. BMC Public Health. 2026 Feb 17;26(1):708. doi: 10.1186/s12889-026-26609-9.
- Individual participant dataSharing planned: No. Swedish law do not allow individual data sharing without ethical permission.
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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.
Daniel Berglind, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schoolyard reconstruction in people with Physical Inactivity and Environmental Exposure, run by Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 6 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 Daniel Berglind, PhD (+46703644797, daniel.berglind@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity levels in children (time frame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in physical activity levels). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865782, which also lists 1 linked publication.
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 20 Jun 2024.