COVID-19NCT04423978
Implications of Covid-19 on the Lifestyle Changes
An observational study of COVID-19, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks of contagion, the Italian government imposed 2.months of complete lock-down, which imposed the social isolation for the whole population and, for those positive to the Covid-19, the complete confinement at home. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 1,826 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2020to 15 Jun 2020
- 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: This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in the province of Reggio Emilia (Italy), an area of high spread of Sars-CoV-2.
Who may be able to join
- adult individuals living in the province of Reggio Emilia (Italy)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of Covid-19 on the Lifestyle Changes and Supports Used (ICOLS): a Survey in the Province of Reggio Emilia
Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks of contagion, the Italian government imposed 2.months of complete lock-down, which imposed the social isolation for the whole population and, for those positive to the Covid-19, the complete confinement at home. Despite the recommendations for conserving healthy lifestyle of the Italian Government, during the lock-down the likelihood to fall into unhealthy behaviours might have increased.
This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in an area of high spread of Sars-CoV-2.
Read the detailed description
The aims of this study were to detect the changes in lifestyles occurred during the imposed lock-down phase and the support services used the most by participants.
This study consists in the administration of an on-line survey addressed to adult individuals living in the province of Reggio Emilia (Italy). The survey was posted on-line on the website of the Azienda USL- IRCCS di Reggio Emilia and it was spread to the community through apps and social networks.
The on-line survey is free to access, self-administered and it consists of 50 questions. The questions investigates the changes occurred in employment status, physical exercise, diet, tobacco and alcohol consumption, sleep quality and leisure activities during the pandemic lock-down phase as well as the available local support services used and perceived as useful.
- Conditions
- COVID-19
- Keywords
- Italy, Lifestyle, Pandemics, Quarantine
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of individuals living in the province of Reggio Emilia who completed the survey
We will report the number of inhabitants of the Province of Reggio Emilia who answered the survey
Measured: 1 month and a half
Secondary outcomes (2)
The ratio of individuals who changed the lifestyles during the lock-down
We will report the number of inhabitants of the Province of Reggio Emilia who changed their lifestyles during the lock-down phase
Measured: 1 month and a half
The number and the type of support services used the most by participants
We will report the number of inhabitants of the Province of Reggio Emilia who used and appreciated the supprt services to overcome the lock-down phase
Measured: 1 month and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 May 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 1,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elisa Mazzini, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423978
- Sponsor's protocol ID
- ICOLS_CovidStyle
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Covid-19 on the Lifestyle Changes and Supports Used (ICOLS): a Survey in the Province of Reggio Emilia
- ClinicalTrials.gov ID
- NCT04423978
- Acronym / sponsor ID
- ICOLS_CovidStyle
- Conditions
- COVID-19
- Keywords
- Italy, Lifestyle, Pandemics, Quarantine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,826 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 4 May 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 9 Jun 2020 (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.
Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks of contagion, the Italian government imposed 2.months of complete lock-down, which imposed the social isolation for the whole population and, for those positive to the Covid-19, the complete confinement at home. Despite the recommendations for conserving healthy lifestyle of the Italian Government, during the lock-down the likelihood to fall into unhealthy behaviours might have increased.
This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in an area of high spread of Sars-CoV-2.
Detailed description
The aims of this study were to detect the changes in lifestyles occurred during the imposed lock-down phase and the support services used the most by participants.
This study consists in the administration of an on-line survey addressed to adult individuals living in the province of Reggio Emilia (Italy). The survey was posted on-line on the website of the Azienda USL- IRCCS di Reggio Emilia and it was spread to the community through apps and social networks.
The on-line survey is free to access, self-administered and it consists of 50 questions. The questions investigates the changes occurred in employment status, physical exercise, diet, tobacco and alcohol consumption, sleep quality and leisure activities during the pandemic lock-down phase as well as the available local support services used and perceived as useful.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in the province of Reggio Emilia (Italy), an area of high spread of Sars-CoV-2.
Key inclusion criteria (1 listed)
- adult individuals living in the province of Reggio Emilia (Italy)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ratio of individuals living in the province of Reggio Emilia who completed the survey
Time frame: 1 month and a half
We will report the number of inhabitants of the Province of Reggio Emilia who answered the survey
2 secondary outcomes
The ratio of individuals who changed the lifestyles during the lock-down
Time frame: 1 month and a half
The number and the type of support services used the most by participants
Time frame: 1 month and a half
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Elisa Mazzini, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
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 COVID-19, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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: finished, as of the sponsor's last update on 12 Jun 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of individuals living in the province of Reggio Emilia who completed the survey (time frame: 1 month and a half). 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 12 Jun 2025.