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Lo studio clinico NCT05865782 per Inattività fisica, Esposizione ambientale, Benessere della salute mentale 1 è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05865782 è uno studio interventistico per Inattività fisica, Esposizione ambientale, Benessere della salute mentale 1, attualmente in arruolamento. Avviato il 22 maggio 2024, prevede di arruolare 3.600 partecipanti. Sotto la guida di Karolinska Institutet, dovrebbe concludersi entro il 30 novembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 giugno 2024.
Sommario breve
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

Descrizione dettagliata
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.

Titolo ufficiale

Skolgårdsprojketet: Bygga om skolgårdar i Stockholm Med grönska för Att öka Skolbarns Fysisk Aktivitet Och hälsa Samt Mildra klimatförändringarna i städer

Condizioni
Inattività fisicaEsposizione ambientaleBenessere della salute mentale 1
Altri ID dello studio
  • The Schoolyard project
Numero NCT
Data di inizio (effettiva)
2024-05-22
Ultimo aggiornamento pubblicato
2024-06-20
Data di completamento (stimata)
2027-11-30
Arruolamento (previsto)
3.600
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Prevenzione
Allocazione
N.D.
Modello di intervento
Sequenziale
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleSchoolyard reconstruction
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.
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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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)
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
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
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
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
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
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
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
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
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
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
Change in number of incidents from 12 months before to 12 months after schoolyard reconstruction
Criteri di eleggibilità

Età idonea
Bambino
Età minima
8 Years
Sessi idonei
Tutti
Accetta volontari sani

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

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
  • 🏛️The City of Stockholm
  • 🏛️Cancerfonden
  • 🏛️Arwidssonstiftelsen
Parte responsabile dello studio
Daniel Berglind, Investigatore principale, Associate Professor, Karolinska Institutet
Contatti principali dello studio
Contatto: Daniel Berglind, PhD, +46703644797, [email protected]
1 Centri dello studio in 1 paesi
Karolinska Institutet, Stockholm, 113 65, Sweden
Daniel Berglind, Phd., Contatto
In arruolamento