Clinical trial NCT05865782: Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes
Official title: Skolgårdsprojketet: Bygga om skolgårdar i Stockholm Med grönska för Att öka Skolbarns Fysisk Aktivitet Och hälsa Samt Mildra klimatförändringarna i städer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Environmental Exposure
Mental Health Wellness 1
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The City of Stockholm
name: Cancerfonden
name: Arwidssonstiftelsen
First posted: 2023-05-19
Enrollment: 3600
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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

1. How does schoolyard reconstruction affect physical activity levels, blood pressure, BMI, mental health, sleep, and sick leave in schoolchildren?
2. 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?
3. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in physical activity levels in children
timeFrame: 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:
measure: Change in musculoskeletal fitness in children
timeFrame: 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)
measure: Change in weight in children
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in weight
measure: Change in height in children
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in height
measure: Change in blood pressure in children
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in blood pressure
measure: Change in mental health in children
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in mental health
measure: Change in sleep in children
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sleep
measure: Change in sick leave
timeFrame: 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sick leave
measure: Change in children's perception of the schoolyard quality
timeFrame: 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
measure: Schoolyard reconstruction costs
timeFrame: Collected through study completion, an average of 1 year
measure: Environmental impact of schoolyard reconstruction
timeFrame: Collected through study completion, an average of 1 year
measure: Incidents in the schoolyard
timeFrame: Change in number of incidents from 12 months before to 12 months after schoolyard reconstruction
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Daniel Berglind, PhD
role: PRINCIPAL_INVESTIGATOR
References: