NCT06274229

Brief Summary

To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 2, 2024

Last Update Submit

February 15, 2024

Conditions

Keywords

Traffic noiseAir pollutionGeneral Health condition

Outcome Measures

Primary Outcomes (1)

  • WHO-5 Well-being Scale

    Validated Questionnaire

    Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented

Secondary Outcomes (2)

  • Kessler K6 psychological distress

    Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented

  • ASKU questionnaire

    Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented

Other Outcomes (2)

  • Questionnaire for General Physiological Health

    Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented

  • Questionnaire about feelings of safety and security at the site

    Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented

Study Arms (10)

Aarhus, installation site

Residents of Aarhus (DK), living at or nearby the site of the installed Intervention

Other: Air pollution and noise reducing installations

Aarhus, control site

Residents of Aarhus (DK), living at or nearby the control site

Bucharest, intervention site

Residents of Bucharest (RO), living at or nearby the site of the installed Intervention

Other: Air pollution and noise reducing installations

Bucharest, control site

Residents of Bucharest (RO), living at or nearby the control site

Castelló, intervention site

Residents of Castelló (ES), living at or nearby the site of the installed Intervention

Other: Air pollution and noise reducing installations

Castelló, control site

Residents of Castelló (ES), living at or nearby the control site

Orvieto, intervention site

Residents of Orvieto (IT), living at or nearby the site of the installed Intervention

Other: Air pollution and noise reducing installations

Orvieto, control site

Residents of Orvieto (IT), living at or nearby the control site

Potsdam, intervention site

Residents of Potsdam (DE), living at or nearby the site of the installed Intervention

Other: Air pollution and noise reducing installations

Potsdam, control site

Residents of Potsdam (DE), living at or nearby the control site

Interventions

A number of means to reduce traffic noise and traffic exhausts and improve air quality will be implemented at designated urban spaces (intervention sites), while other places with comparable amount of traffic and no such changes will serve as control sites.

Aarhus, installation siteBucharest, intervention siteCastelló, intervention siteOrvieto, intervention sitePotsdam, intervention site

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of the five cities (18+ years of age)

You may qualify if:

  • Participants must live or work at or near the installation (intervention group) or control site (control group)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité -- Universitaetsmedizin Berlin

Berlin, 14109, Germany

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalPsychological Well-Being

Interventions

Air Pollution

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Environmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Andreas Michalsen, Prof MD

    Charite Universitaetsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farid I Kandil, PhD

CONTACT

Etienne Hanslian, MD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 23, 2024

Study Start

February 20, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations