## Protocol Section
### Identification Module
**NCT ID:** NCT04742179

**Acronym:** CLIMACTIONS

**Brief Title:** Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.

**Official Title:** Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.

#### Organization Study ID Info
**ID:** 11/2020
#### Organization
**Class:** OTHER
**Full Name:** Istituto per la Ricerca e l'Innovazione Biomedica
### Status Module
#### Completion Date
**Date:** 2022-05-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-11

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-11

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2021-02-05
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-28
**Study First Submit QC Date:** 2021-02-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto per la Ricerca e l'Innovazione Biomedica

#### Responsible Party

**Investigator Affiliation:** Istituto per la Ricerca e l'Innovazione Biomedica

**Investigator Full Name:** Stefania La Grutta, MD

**Investigator Title:** Research Manager

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Respiratory and Allergic Symptoms

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 175

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The children belonging to the classes of the school complex undergoing the maintenance intervention.

**Intervention Names:**

- Other: Manteinance and care intervention on the green areas.

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The children belonging to the classes of the school complex that will not undergo the maintenance intervention.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** Manteinance and care intervention on the green areas.

**Name:** Manteinance and care intervention on the green areas.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Presence of asthma symptoms before the maintenance intervention

**Measure:** Asthma symptoms at baseline

**Time Frame:** Before the maintenance intervention

**Description:** Presence of rhinitis symptoms before the maintenance intervention

**Measure:** Rhinitis symptoms at baseline

**Time Frame:** Before the maintenance intervention

**Description:** Presence of conjunctivitis symptoms before the maintenance intervention

**Measure:** Conjunctivitis symptoms at baseline

**Time Frame:** Before the maintenance intervention

**Description:** Presence of asthma symptoms after the maintenance intervention

**Measure:** Asthma symptoms at follow-up

**Time Frame:** 7 days after the maintenance intervention

**Description:** Presence of rhinitis symptoms after the maintenance intervention

**Measure:** Rhinitis symptoms at follow-up

**Time Frame:** 7 days after the maintenance intervention

**Description:** Presence of conjunctivitis symptoms after the maintenance intervention

**Measure:** Conjunctivitis symptoms at follow-up

**Time Frame:** 7 days after the maintenance intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* no exclusion criteria

**Maximum Age:** 11 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Palermo

**Country:** Italy

**Facility:** Institute of Translational Pharmacology

**Zip:** 90146

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
