Cognitive Function 1, SocialGRASNCT04898439
GReen And Healthy Schools
A study testing greening of the school environment in people with Cognitive Function 1, Social and Cognitive Change, run by Hasselt University at 1 site in Belgium.
Trial summary
This project aims to investigate the health effects of making schools greener and more biodiverse. We will mainly focus on cognitive effects, well-being, and BMI. The research hypothesis is that greening schools positively influences the health of children through more exercise and cleaner air. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social, Cognitive Change, Emotions
- What is being tested?
- greening of the school environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being in 4th, 5th, or 6th grade
- Signed informed consent form by a legal representative
Who cannot join
- No knowledge of dutch
Trial locations and contacts
1 site in 1 country.
Silvie Daniels, PhD contact
About this study
Official title: The Effect of Greening the School Environment on the Health of Children
This project aims to investigate the health effects of making schools greener and more biodiverse. We will mainly focus on cognitive effects, well-being, and BMI. The research hypothesis is that greening schools positively influences the health of children through more exercise and cleaner air.
Read the 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.
- Conditions
- Cognitive Function 1, Social, Cognitive Change, Emotions, Weight, Body, Pollution; Exposure
- Being tested
- greening of the school environment
- Keywords
- greening of schools, biodiversity, cognition, BMI
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
greening of the school environmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Green school | Experimental | 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. Receives: Other: greening of the school environment |
| control school | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
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.
Measured: At the baseline, after 6 months and through study completion, an average of 1 year
Change in wellbeing
We measure the emotional wellbeing by means of the Kids screen test that builds a score of 27 points.
Measured: at the baseline, after 6 months and through study completion, an average of 1 year
Change in anthropometry
We measure BMI and waist/hip circumference. They are expressed as kg/m2 and cm.
Measured: at the baseline, after 6 months and through study completion, an average of 1 year
Change in black carbon levels
We measure urinary black carbon levels. They are expressed as particles per mm2.
Measured: at the baseline, after 6 months and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start15 Mar 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We have 2 groups: an intervention group that includes children from school that will have more nature in its environment and a control school
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Plusquin, Hasselt University
- Investigators
- Michelle Plusquin, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898439
- Sponsor's protocol ID
- Green_School
- Acronym
- GRAS
- Status last verified
- Mar 2022
- First submitted
- 10 May 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the protocol and pseudonymised data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Greening the School Environment on the Health of Children
- ClinicalTrials.gov ID
- NCT04898439
- Acronym / sponsor ID
- GRAS / Green_School
- Conditions
- Cognitive Function 1, Social, Cognitive Change, Emotions, Weight, Body, Pollution; Exposure
- Keywords
- greening of schools, biodiversity, cognition, BMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to investigate the health effects of making schools greener and more biodiverse. We will mainly focus on cognitive effects, well-being, and BMI. The research hypothesis is that greening schools positively influences the health of children through more exercise and cleaner air.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We have 2 groups: an intervention group that includes children from school that will have more nature in its environment and a control school
| Arm | Type | Receives |
|---|---|---|
| Green school | Experimental | Other: greening of the school environmentThe 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. |
| control school | No intervention | –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 |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being in 4th, 5th, or 6th grade
- Signed informed consent form by a legal representative
Key exclusion criteria (1 listed)
- No knowledge of dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| greening of the school environmentThe 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. | Other | Green school |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Yes. the protocol and pseudonymised data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvie Daniels, PhD contact
Michelle Plusquin principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing greening of the school environment in people with Cognitive Function 1, Social and Cognitive Change, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Plusquin, PhD (+3211268289, michelle.plusquin@uhasselt.Be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: At the baseline, after 6 months and through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.