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Implications of Covid-19 on the Lifestyle Changes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423978
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Elisa Mazzini, Azienda Unità Sanitaria Locale Reggio Emilia

Brief 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. 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.


Condition or disease
COVID-19

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.

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Study Type : Observational
Actual Enrollment : 1826 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Implications of Covid-19 on the Lifestyle Changes and Supports Used (ICOLS): a Survey in the Province of Reggio Emilia
Actual Study Start Date : May 4, 2020
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The ratio of individuals who changed the lifestyles during the lock-down [ Time Frame: 1 month and a half ]
    We will report the number of inhabitants of the Province of Reggio Emilia who changed their lifestyles during the lock-down phase

  2. The number and the type of support services used the most by participants [ Time Frame: 1 month and a half ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • adult individuals living in the province of Reggio Emilia (Italy)

Exclusion Criteria:

-


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): NCT04423978


Locations
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Italy
Elisa Mazzini
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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Principal Investigator: Elisa Mazzini, MD Azienda USL - IRCCS di Reggio Emilia
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Responsible Party: Elisa Mazzini, Medical Doctor, Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT04423978    
Other Study ID Numbers: ICOLS_CovidStyle
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisa Mazzini, Azienda Unità Sanitaria Locale Reggio Emilia:
Italy
Lifestyle
Pandemics
Quarantine