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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05865782
Other study ID # The Schoolyard project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 22, 2024
Est. completion date November 30, 2027

Study information

Verified date May 2024
Source Karolinska Institutet
Contact Daniel Berglind, PhD
Phone +46703644797
Email daniel.berglind@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3600
Est. completion date November 30, 2027
Est. primary completion date May 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 13 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Schoolyard reconstruction
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.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (4)

Lead Sponsor Collaborator
Karolinska Institutet Arwidssonstiftelsen, Cancerfonden, The City of Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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). 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)
Secondary Change in weight in children Weight (in kilograms) will be measured with validated scales 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in weight
Secondary Change in height in children Height (in centimeters) will be measured with validated stadiometers 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in height
Secondary 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 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in blood pressure
Secondary 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 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in mental health
Secondary 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 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sleep
Secondary Change in sick leave Sick leave frequency and duration (occasions and days) will be collected from a Stockholm City database 12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in sick leave
Secondary 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 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
Secondary 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 Collected through study completion, an average of 1 year
Secondary Environmental impact of schoolyard reconstruction Based on greenery increase from the schoolyard reconstruction we will use models for impact on CO2-emissions and albedo (?a) scores (i.e., reflective properties from greenery) as environmental benefit outcomes Collected through study completion, an average of 1 year
Secondary Incidents in the schoolyard Number of incidents (e.g., conflicts, sun burns etc.) from before to after schoolyard reconstruction Change in number of incidents from 12 months before to 12 months after schoolyard reconstruction
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