Physical Inactivity Clinical Trial
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: 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
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Arwidssonstiftelsen, Cancerfonden, The City of Stockholm |
Sweden,
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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