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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742179
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory and Allergic Symptoms Other: Manteinance and care intervention on the green areas. Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
Estimated Study Start Date : January 11, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Asthma symptoms at baseline [ Time Frame: Before the maintenance intervention ]
    Presence of asthma symptoms before the maintenance intervention

  2. Rhinitis symptoms at baseline [ Time Frame: Before the maintenance intervention ]
    Presence of rhinitis symptoms before the maintenance intervention

  3. Conjunctivitis symptoms at baseline [ Time Frame: Before the maintenance intervention ]
    Presence of conjunctivitis symptoms before the maintenance intervention

  4. Asthma symptoms at follow-up [ Time Frame: 7 days after the maintenance intervention ]
    Presence of asthma symptoms after the maintenance intervention

  5. Rhinitis symptoms at follow-up [ Time Frame: 7 days after the maintenance intervention ]
    Presence of rhinitis symptoms after the maintenance intervention

  6. Conjunctivitis symptoms at follow-up [ Time Frame: 7 days after the maintenance intervention ]
    Presence of conjunctivitis symptoms after the maintenance intervention


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742179


Contacts
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Contact: Stefania La Grutta, MD 0916809194 stefania.lagrutta@irib.cnr.it

Sponsors and Collaborators
Istituto per la Ricerca e l'Innovazione Biomedica
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Stefania La Grutta, MD, Research Manager, Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT04742179    
Other Study ID Numbers: 11/2020
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No