NCT04898439

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 10, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 10, 2021

Last Update Submit

March 15, 2022

Conditions

Keywords

greening of schoolsbiodiversitycognitionBMI

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    at the baseline, after 6 months and through study completion, an average of 1 year

Study Arms (2)

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.

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

Interventions

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.

Green school

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being in 4th, 5th, or 6th grade
  • Signed informed consent form by a legal representative

You may not qualify if:

  • No knowledge of dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3590, Belgium

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle Plusquin

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Plusquin, PhD

CONTACT

Silvie Daniels, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Children will know whether their school is having more nature
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We have 2 groups: an intervention group that includes children from school that will have more nature in its environment and a control school
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent professor

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 24, 2021

Study Start

March 15, 2022

Primary Completion

December 1, 2022

Study Completion

April 1, 2023

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

the protocol and pseudonymised data will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
1/9/2021 - 30/12/2022
Access Criteria
UHasselt shared drive

Locations