- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898439
GReen And Healthy Schools (GRAS)
The Effect of Greening the School Environment on the Health of Children
Study Overview
Status
Intervention / Treatment
Detailed Description
Spending time in nature has been associated with improved physical and mental health and well-being. Developing nature-based health-promoting interventions such as providing more nature in schools to improve children's well-being will lead to benefits for society in our rapidly urbanizing world. Although the benefits of exposure to nature have been demonstrated, knowledge of integrating exposure to nature into public health guidelines is scarce. The latter requires an interdisciplinary approach that integrates the impact of nature-based interventions both on health and on the cost-effectiveness of interventions. Little is known about the health effect of greening and, in particular, increasing biodiversity in schools and we want to investigate further with this study.
This project, therefore, aims to investigate the health effects of greening primary schools and increasing biodiversity and will mainly focus on the effects on cognition, well-being, and BMI. For this, all children from 4th to 6th grade in the participating schools will be invited to participate in this study (Belgium). This study comprises control schools and intervention schools, the schools are examined before the greening and after the greening.
When the informed consent form is signed by the parents, they complete a questionnaire that assesses the child's diet, physical activity, and general questions. A urine sample will be taken for the determination of black carbon particles. The child will also perform computer tests measuring different aspects of "cognition". During these tests, we will also look at the eye movements that play an important role in the cognitive ability of the child. To get an idea of a possible effect on BMI, height and weight will be measured. The child fills in a welfare questionnaire and a questionnaire about the perception of nature itself.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle Plusquin, PhD
- Phone Number: +3211268289
- Email: michelle.plusquin@uhasselt.Be
Study Contact Backup
- Name: Silvie Daniels, PhD
- Email: silvie.daniels@uhasselt.be
Study Locations
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Limburg
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Hasselt, Limburg, Belgium, 3590
- Hasselt University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being in 4th, 5th, or 6th grade
- Signed informed consent form by a legal representative
Exclusion Criteria:
- No knowledge of dutch
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Green school
The children from schools that are being greened will be investigated and compared to the control school.
We will measure cognitive function, BMI, black carbon levels and emotional wellbeing.
|
The school will be greened and biodiversity will be increased.
This will be done on the playground and area around the school.
Special needs corners for playing, relaxing or gardening will be installed.
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No Intervention: control school
The children from schools that are not being greened will be investigated and used as a control group.
We will measure cognitive function, BMI, black carbon levels and emotional wellbeing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive function
Time Frame: At the baseline, after 6 months and through study completion, an average of 1 year
|
We measure the cognitive function of children by means of a battery of tests including: stroop test, Continuous Performance, digit span, digit signal and digit selection.
We combine the computer tests with eye tracking to provide information about saccadic gain during the tests.
The computer tests provide data on how much time per reaction (msec) was needed or how many digits could be remembered.
|
At the baseline, after 6 months and through study completion, an average of 1 year
|
Change in wellbeing
Time Frame: at the baseline, after 6 months and through study completion, an average of 1 year
|
We measure the emotional wellbeing by means of the Kids screen test that builds a score of 27 points.
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at the baseline, after 6 months and through study completion, an average of 1 year
|
Change in anthropometry
Time Frame: at the baseline, after 6 months and through study completion, an average of 1 year
|
We measure BMI and waist/hip circumference.
They are expressed as kg/m2 and cm.
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at the baseline, after 6 months and through study completion, an average of 1 year
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Change in black carbon levels
Time Frame: at the baseline, after 6 months and through study completion, an average of 1 year
|
We measure urinary black carbon levels.
They are expressed as particles per mm2.
|
at the baseline, after 6 months and through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle Plusquin, Hasselt University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Green_School
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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