Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits. (CLIMACTIONS)

This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas.

All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention.

The study will involve three phases.

1. During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes.
2. During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex.
3. During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.

Study Overview

• Status: Completed
• Conditions: Respiratory and Allergic Symptoms
• Intervention / Treatment: Other: Manteinance and care intervention on the green areas.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90146
    • Institute of Translational Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female gender
• age between 7 and 11 years

Exclusion Criteria:

• no exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The children belonging to the classes of the school complex undergoing the maintenance intervention.	Other: Manteinance and care intervention on the green areas.; Manteinance and care intervention on the green areas.
No Intervention: Control group; The children belonging to the classes of the school complex that will not undergo the maintenance intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma symptoms at baseline	Presence of asthma symptoms before the maintenance intervention	Before the maintenance intervention
Rhinitis symptoms at baseline	Presence of rhinitis symptoms before the maintenance intervention	Before the maintenance intervention
Conjunctivitis symptoms at baseline	Presence of conjunctivitis symptoms before the maintenance intervention	Before the maintenance intervention
Asthma symptoms at follow-up	Presence of asthma symptoms after the maintenance intervention	7 days after the maintenance intervention
Rhinitis symptoms at follow-up	Presence of rhinitis symptoms after the maintenance intervention	7 days after the maintenance intervention
Conjunctivitis symptoms at follow-up	Presence of conjunctivitis symptoms after the maintenance intervention	7 days after the maintenance intervention

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 11/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No