Psychological StressDivAirCitySHNCT06274229
DivAirCity Social Health Survey
An observational study of Psychological Stress and Psychological Well-Being, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Psychological Well-Being, Pollution; Exposure
- What is being tested?
- Air pollution and noise reducing installations
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the five cities (18+ years of age)
Who may be able to join
- Participants must live or work at or near the installation (intervention group) or control site (control group)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité -- Universitaetsmedizin Berlin
Berlin, 14109
Farid I Kandil, PhD, +491605631744, farid-ihab.kandil@charite.de
About this study
Official title: Anonymous Survey Among Local Residents on the Impact of the Planned Measures in the Five Partner Cities of the DivAirCity Project on Their Social Life, Health and Well-being
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).
Read the detailed description
Scientific studies show that increased stress can favor the development of e.g. high blood pressure, heart disease, mental illness, infectious diseases, headaches and sleep disorders. This means that stress causes considerable costs for western healthcare systems, including in our city and this neighbourhood. In large cities, where there are often hardly any natural green and forest areas left, depression and anxiety syndromes, for example, are more common than among the rural population.
For example, in Germany, more than three quarters of the population live in densely or moderately populated areas, while the global average is more than 50 per cent. Due to increasing urbanisation, people living in cities will be heavily dependent on urban nature, which can be a relevant health-promoting factor. Several studies have shown that natural spaces such as city parks, parks and even greenery on streets have a positive impact on the health of residents, both individually and collectively.
The European Council Horizon 2020 project DivAirCity (acronym explanation in the text below) is about making formerly busy public spaces in European cities more attractive again for residents and citizens. The aim is to redesign the spaces in such a way that people of different age groups, social classes and identities ("Div") can (once again) come together and meet in these places on a daily basis. To this end, these places are to be changed through various installations (planting trees, redesigning parks, shading, watering in summer) in such a way that the local air quality ("Air") in the cities ("City") improves significantly. This is realized on the one hand by installing air quality measuring equipment and by recording the number of people and the time they spend in these places (objective measurements).
In addition to these objective measurements, this study records the impact on psychological and physiological health that the installations (intervention) has on the residents. To this end, it will be measured how residents feel in terms of quality of life, current stress, general health, and whether they feel safe and secure in the specific place (comfort, safety and security) and whether they enjoy going there and staying there,. These measurements will take place both before (day -60 to day -30) and after (day +30 and day +60) the installment of the intervention.
Finally, we would like to know your age group, your gender and how close you live to the location of the conversion/installation. We would like to invite you to take part in this survey again after the remodelling project.
- Being tested
- Air pollution and noise reducing installations
- Keywords
- Traffic noise, Air pollution, General Health condition
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air pollution and noise reducing installationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aarhus, installation site | Residents of Aarhus (DK), living at or nearby the site of the installed Intervention Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Air pollution and noise reducing installations | |
| Potsdam, control site | Residents of Potsdam (DE), living at or nearby the control site |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO-5 Well-being Scale
Validated Questionnaire
Measured: 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
Validated Questionnaire
Measured: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
ASKU questionnaire
Validates Questionnaire for self-efficacy
Measured: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València, Universitatea din Bucuresti, University of Aarhus, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, European Commission
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof MD, Principal investigator, Charite Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274229
- Sponsor's protocol ID
- EA4/252/23
- Acronym
- DivAirCitySH
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anonymous Survey Among Local Residents on the Impact of the Planned Measures in the Five Partner Cities of the DivAirCity Project on Their Social Life, Health and Well-being
- ClinicalTrials.gov ID
- NCT06274229
- Acronym / sponsor ID
- DivAirCitySH / EA4/252/23
- Keywords
- Traffic noise, Air pollution, General Health condition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València, Universitatea din Bucuresti, University of Aarhus, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, European Commission
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Scientific studies show that increased stress can favor the development of e.g. high blood pressure, heart disease, mental illness, infectious diseases, headaches and sleep disorders. This means that stress causes considerable costs for western healthcare systems, including in our city and this neighbourhood. In large cities, where there are often hardly any natural green and forest areas left, depression and anxiety syndromes, for example, are more common than among the rural population.
For example, in Germany, more than three quarters of the population live in densely or moderately populated areas, while the global average is more than 50 per cent. Due to increasing urbanisation, people living in cities will be heavily dependent on urban nature, which can be a relevant health-promoting factor. Several studies have shown that natural spaces such as city parks, parks and even greenery on streets have a positive impact on the health of residents, both individually and collectively.
The European Council Horizon 2020 project DivAirCity (acronym explanation in the text below) is about making formerly busy public spaces in European cities more attractive again for residents and citizens. The aim is to redesign the spaces in such a way that people of different age groups, social classes and identities ("Div") can (once again) come together and meet in these places on a daily basis. To this end, these places are to be changed through various installations (planting trees, redesigning parks, shading, watering in summer) in such a way that the local air quality ("Air") in the cities ("City") improves significantly. This is realized on the one hand by installing air quality measuring equipment and by recording the number of people and the time they spend in these places (objective measurements).
In addition to these objective measurements, this study records the impact on psychological and physiological health that the installations (intervention) has on the residents. To this end, it will be measured how residents feel in terms of quality of life, current stress, general health, and whether they feel safe and secure in the specific place (comfort, safety and security) and whether they enjoy going there and staying there,. These measurements will take place both before (day -60 to day -30) and after (day +30 and day +60) the installment of the intervention.
Finally, we would like to know your age group, your gender and how close you live to the location of the conversion/installation. We would like to invite you to take part in this survey again after the remodelling project.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Aarhus, installation site | – | Other: Air pollution and noise reducing installationsResidents of Aarhus (DK), living at or nearby the site of the installed Intervention |
| Aarhus, control site | – | –Residents of Aarhus (DK), living at or nearby the control site |
| Bucharest, intervention site | – | Other: Air pollution and noise reducing installationsResidents of Bucharest (RO), living at or nearby the site of the installed Intervention |
| Bucharest, control site | – | –Residents of Bucharest (RO), living at or nearby the control site |
| Castelló, intervention site | – | Other: Air pollution and noise reducing installationsResidents of Castelló (ES), living at or nearby the site of the installed Intervention |
| Castelló, control site | – | –Residents of Castelló (ES), living at or nearby the control site |
| Orvieto, intervention site | – | Other: Air pollution and noise reducing installationsResidents of Orvieto (IT), living at or nearby the site of the installed Intervention |
| Orvieto, control site | – | –Residents of Orvieto (IT), living at or nearby the control site |
| Potsdam, intervention site | – | Other: Air pollution and noise reducing installationsResidents of Potsdam (DE), living at or nearby the site of the installed Intervention |
| Potsdam, control site | – | –Residents of Potsdam (DE), living at or nearby the control site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the five cities (18+ years of age)
Key inclusion criteria (1 listed)
- Participants must live or work at or near the installation (intervention group) or control site (control group)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air pollution and noise reducing installationsA 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. | Other | Aarhus, installation site, Bucharest, intervention site, Castelló, intervention site, Orvieto, intervention site, Potsdam, intervention site |
Primary outcome
WHO-5 Well-being Scale
Time frame: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Validated Questionnaire
2 secondary outcomes
Kessler K6 psychological distress
Time frame: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
ASKU questionnaire
Time frame: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof MD principal investigator
Charite Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Psychological Well-Being, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farid I Kandil, PhD (+493080505 ext. 770, farid-ihab.kandil@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO-5 Well-being Scale (time frame: Baseline: 60 to 30 days before the installation implementation vs Posttest: 30 to 60 days after the installation has been implemented). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.