NCT05865782

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
May 2024Nov 2027

First Submitted

Initial submission to the registry

March 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

June 20, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

March 29, 2023

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in musculoskeletal fitness in children

    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

    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

    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

    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

    12 months change from baseline (in May before schoolyard reconstruction) to 1-year follow-up (in May 1 year later) in mental health

  • +6 more secondary outcomes

Study Arms (1)

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.

Behavioral: Schoolyard reconstruction

Interventions

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.

Schoolyard reconstruction

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • On school level:
  • School selected for schoolyard reconstruction by the City of Stockholm
  • On individual level (schoolchildren):
  • Enrolled in participating school
  • years old at the time of study start
  • In 2nd or 5th grade
  • Parents signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 113 65, Sweden

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Daniel Berglind, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Berglind, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 19, 2023

Study Start

May 22, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

June 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Swedish law do not allow individual data sharing without ethical permission.

Locations