<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04423978</url>
  </required_header>
  <id_info>
    <org_study_id>ICOLS_CovidStyle</org_study_id>
    <nct_id>NCT04423978</nct_id>
  </id_info>
  <brief_title>Implications of Covid-19 on the Lifestyle Changes</brief_title>
  <official_title>Implications of Covid-19 on the Lifestyle Changes and Supports Used (ICOLS): a Survey in the Province of Reggio Emilia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks&#xD;
      of contagion, the Italian government imposed 2.months of complete lock-down, which imposed&#xD;
      the social isolation for the whole population and, for those positive to the Covid-19, the&#xD;
      complete confinement at home. Despite the recommendations for conserving healthy lifestyle of&#xD;
      the Italian Government, during the lock-down the likelihood to fall into unhealthy behaviours&#xD;
      might have increased.&#xD;
&#xD;
      This study aims to describe the impact of Covid-19 on the lifestyles of a population of&#xD;
      Italian adults living in an area of high spread of Sars-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of this study were to detect the changes in lifestyles occurred during the imposed&#xD;
      lock-down phase and the support services used the most by participants.&#xD;
&#xD;
      This study consists in the administration of an on-line survey addressed to adult individuals&#xD;
      living in the province of Reggio Emilia (Italy). The survey was posted on-line on the website&#xD;
      of the Azienda USL- IRCCS di Reggio Emilia and it was spread to the community through apps&#xD;
      and social networks.&#xD;
&#xD;
      The on-line survey is free to access, self-administered and it consists of 50 questions. The&#xD;
      questions investigates the changes occurred in employment status, physical exercise, diet,&#xD;
      tobacco and alcohol consumption, sleep quality and leisure activities during the pandemic&#xD;
      lock-down phase as well as the available local support services used and perceived as useful.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2020</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The ratio of individuals living in the province of Reggio Emilia who completed the survey</measure>
    <time_frame>1 month and a half</time_frame>
    <description>We will report the number of inhabitants of the Province of Reggio Emilia who answered the survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ratio of individuals who changed the lifestyles during the lock-down</measure>
    <time_frame>1 month and a half</time_frame>
    <description>We will report the number of inhabitants of the Province of Reggio Emilia who changed their lifestyles during the lock-down phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number and the type of support services used the most by participants</measure>
    <time_frame>1 month and a half</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Actual">1826</enrollment>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study aims to describe the impact of Covid-19 on the lifestyles of a population of&#xD;
        Italian adults living in the province of Reggio Emilia (Italy), an area of high spread of&#xD;
        Sars-CoV-2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult individuals living in the province of Reggio Emilia (Italy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa Mazzini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda USL - IRCCS di Reggio Emilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elisa Mazzini</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Unità Sanitaria Locale Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Elisa Mazzini</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Italy</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Pandemics</keyword>
  <keyword>Quarantine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423978
org study id: ICOLS_CovidStyle
nct id: NCT04423978
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: The ratio of individuals living in the province of Reggio Emilia who completed the survey
time frame: 1 month and a half
description: We will report the number of inhabitants of the Province of Reggio Emilia who answered the survey
measure: The ratio of individuals who changed the lifestyles during the lock-down
time frame: 1 month and a half
description: We will report the number of inhabitants of the Province of Reggio Emilia who changed their lifestyles during the lock-down phase
measure: The number and the type of support services used the most by participants
time frame: 1 month and a half
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elisa Mazzini, MD
role: Principal Investigator
affiliation: Azienda USL - IRCCS di Reggio Emilia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Unità Sanitaria Locale Reggio Emilia
investigator full name: Elisa Mazzini
investigator title: Medical Doctor
mesh term: COVID-19