<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/NCT04422262</url>
  </required_header>
  <id_info>
    <org_study_id>DEP 1/2020</org_study_id>
    <nct_id>NCT04422262</nct_id>
  </id_info>
  <brief_title>Analysis of Long Term Risk of Coronavirus Disease-19 Emergency</brief_title>
  <acronym>ALTRISCOVID-19</acronym>
  <official_title>Impact of the Italian Lockdown on Lifestyles and Psychosocial Status of the Moli-Sani Study Cohort and the Italian General Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neuromed IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neuromed IRCCS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate dietary, lifestyle and psychosocial changes possibly&#xD;
      occurred during Italy's lockdown, that is in the period of time between March 9 2020 and May&#xD;
      3 2020 (hereafter referred to as the Phase 1 lockdown) in two different populations: the&#xD;
      Moli-sani Study cohort and the Italian general population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The containment measures released by the Italian Government for the period between March 9-&#xD;
      May 3 2020 have been aimed to reduce the movement of people from their homes, which was only&#xD;
      allowed in cases of special need, and the use of smart work (working from home) wherever&#xD;
      possible .As a consequence, the lockdown period is likely to have lasting effects on people&#xD;
      and their lifestyles, especially nutrition, and psychosocial well-being.&#xD;
&#xD;
      A web-based questionnaire was developed to retrospectively investigate dietary, lifestyle and&#xD;
      psychosocial changes possibly occurred during Italy's lockdown, that is in the period of time&#xD;
      between March 9 2020 and May 3 2020 (hereafter referred to as the Phase 1 lockdown).&#xD;
&#xD;
      The potential impact of Phase 1 lockdown on lifestyles will be tested in two distinct&#xD;
      population cohorts, that is the Moli-sani Study cohort (established among residents in the&#xD;
      Molise region in the period 2005-2010) and a sample of the general Italian population, aged ≥&#xD;
      18 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing changes in smoking status during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential modifications in smoking habits, by administering specific questions on how and to what extent this behavior has been modified during lockdown.&#xD;
The questions will investigate whether during the Italian lockdown smokers have increased the daily number of cigarettes, or whether they quitted, and whether nonsmokers have started to smoke and to what extent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing changes in physical activity during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential modifications in physical activity, by administering specific questions on how and to what extent this behavior has been modified during lockdown.&#xD;
The questions will investigate whether during the Italian lockdown subjects have experienced a reduction of their usual exercise in terms of minutes per week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing changes in work-related activities during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential modifications in working and work-related activities, by administering specific questions on how and to what extent work-related issues have been modified during lockdown.&#xD;
The questions will investigate whether during the Italian lockdown subjects have shifted to smart working, experienced job loss/reduction, salary reductions, used public transport to go to work.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing changes in social habits during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential modifications in social life, by administering specific questions on how and to what extent social habits have been modified during lockdown.&#xD;
The questions will investigate how often during the Italian lockdown subjects used to go out on average during the week, and on what occasions they were used to use masks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing changes in dietary habits during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential modifications in frequency consumption of several food groups, with a specific focus on those typical of a Mediterranean diet, by administering specific questions on whether the consumption of several food groups have been modified during lockdown. The questions are 'Please indicate whether the consumption of each of the following foods has been changed during the lockdown as compared to your usual intake'. Possible answers are 'not changed', 'increased' or 'decreased'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing depression during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing anxiety during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing stress during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing post-traumatic stress disorder during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate potential onset of post-traumatic stress disorder during the Italian lockdown by administering the Screening Questionnaire for Disaster Mental Health -SQD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing social support during Italian lockdown</measure>
    <time_frame>From March 9 2020 to May 3 2020</time_frame>
    <description>The study will evaluate social support through questions asking how much during the lockdown period people could count on the support / help of people (e.g. relatives, friends, neighbors, health care professionals, etc).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4307</enrollment>
  <condition>Lifestyle</condition>
  <condition>Dietary Habits</condition>
  <condition>Psychosocial Problem</condition>
  <arm_group>
    <arm_group_label>Moli-sani Study sub-cohort</arm_group_label>
    <description>A sample of 2,500 men and women from the Moli-sani Study cohort (2005-2010) who were re-examined in 2017-2020. Participants will be contacted by telephone by researchers of the Moli-sani Study recruitment team in order to collect dietary, lifestyle and psychosocial information and assess potential changes possibly occurred during Phase 1 lockdown.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Italian general population</arm_group_label>
    <description>The project will retrospectively collect data through a web-based survey using Google form. The questionnaire consists of the same items used for the Moli-sani sub-cohort. The project aims at including as many subjects' records as possible.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Moli-sani Study sub-cohort A sample of 2,500 men and women from the Moli-sani Study cohort&#xD;
        (2005-2010) who were re-examined in 2017-2020. Participants will be contacted by telephone&#xD;
        by researchers of the Moli-sani Study recruitment team in order to collect dietary,&#xD;
        lifestyle and psychosocial information and assess potential changes possibly occurred&#xD;
        during Phase 1 lockdown. This project will be hereafter referred to as Moli-LOCK Study.&#xD;
&#xD;
        Italian general population The project will retrospectively collect data through a&#xD;
        web-based survey using Google form. The questionnaire consists of the same items used in&#xD;
        the Moli-LOCK Study. The investigators aim at including as many subjects' records as&#xD;
        possible. This project will be hereafter referred to as ALT RISCOVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for the Moli-sani Study sub-cohort:&#xD;
&#xD;
          -  Re-examination in 2017-2020;&#xD;
&#xD;
          -  Able to give verbal consent&#xD;
&#xD;
        Exclusion criteria for the Moli-sani Study sub-cohort:&#xD;
&#xD;
        - Not able to give verbal consent&#xD;
&#xD;
        Inclusion Criteria for the General Italian population cohort:&#xD;
&#xD;
          -  Age &gt;= 18 years.&#xD;
&#xD;
          -  All subjects from the general population with access to electronic devices and the&#xD;
             Internet (e.g. personal computer, smartphone) and is fluent in Italian will be&#xD;
             eligible.&#xD;
&#xD;
        Exclusion Criteria for the General Italian population cohort:&#xD;
&#xD;
          -  Subjects younger than 18 years&#xD;
&#xD;
          -  Only people with access to personal computers, smartphones and the Internet, and&#xD;
             fluency in Italian will be able to participate. These exclusions are not based on age,&#xD;
             gender, pregnancy, racial, or ethnic origin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Licia Iacoviello, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Neuromed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS Neuromed</name>
      <address>
        <city>Pozzilli</city>
        <zip>86079</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Neuromed IRCCS</investigator_affiliation>
    <investigator_full_name>Licia Iacoviello</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pandemic</keyword>
  <keyword>lockdown</keyword>
  <keyword>lifestyles</keyword>
  <keyword>dietary habits</keyword>
  <keyword>psychosocial factors</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04422262
org study id: DEP 1/2020
nct id: NCT04422262
lead sponsor: 
has dmc: No
is fda regulated drug: No
The aim of this study is to investigate dietary, lifestyle and psychosocial changes possibly
      occurred during Italy's lockdown, that is in the period of time between March 9 2020 and May
      3 2020 (hereafter referred to as the Phase 1 lockdown) in two different populations: the
      Moli-sani Study cohort and the Italian general population.
The containment measures released by the Italian Government for the period between March 9-
      May 3 2020 have been aimed to reduce the movement of people from their homes, which was only
      allowed in cases of special need, and the use of smart work (working from home) wherever
      possible .As a consequence, the lockdown period is likely to have lasting effects on people
      and their lifestyles, especially nutrition, and psychosocial well-being.

      A web-based questionnaire was developed to retrospectively investigate dietary, lifestyle and
      psychosocial changes possibly occurred during Italy's lockdown, that is in the period of time
      between March 9 2020 and May 3 2020 (hereafter referred to as the Phase 1 lockdown).

      The potential impact of Phase 1 lockdown on lifestyles will be tested in two distinct
      population cohorts, that is the Moli-sani Study cohort (established among residents in the
      Molise region in the period 2005-2010) and a sample of the general Italian population, aged ≥
      18 years.
observational model: Cohort
time perspective: Retrospective
measure: Assessing changes in smoking status during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential modifications in smoking habits, by administering specific questions on how and to what extent this behavior has been modified during lockdown.
The questions will investigate whether during the Italian lockdown smokers have increased the daily number of cigarettes, or whether they quitted, and whether nonsmokers have started to smoke and to what extent.
measure: Assessing changes in physical activity during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential modifications in physical activity, by administering specific questions on how and to what extent this behavior has been modified during lockdown.
The questions will investigate whether during the Italian lockdown subjects have experienced a reduction of their usual exercise in terms of minutes per week.
measure: Assessing changes in work-related activities during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential modifications in working and work-related activities, by administering specific questions on how and to what extent work-related issues have been modified during lockdown.
The questions will investigate whether during the Italian lockdown subjects have shifted to smart working, experienced job loss/reduction, salary reductions, used public transport to go to work.
measure: Assessing changes in social habits during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential modifications in social life, by administering specific questions on how and to what extent social habits have been modified during lockdown.
The questions will investigate how often during the Italian lockdown subjects used to go out on average during the week, and on what occasions they were used to use masks.
measure: Assessing changes in dietary habits during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential modifications in frequency consumption of several food groups, with a specific focus on those typical of a Mediterranean diet, by administering specific questions on whether the consumption of several food groups have been modified during lockdown. The questions are 'Please indicate whether the consumption of each of the following foods has been changed during the lockdown as compared to your usual intake'. Possible answers are 'not changed', 'increased' or 'decreased'.
measure: Assessing depression during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) .
measure: Assessing anxiety during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7).
measure: Assessing stress during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4).
measure: Assessing post-traumatic stress disorder during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate potential onset of post-traumatic stress disorder during the Italian lockdown by administering the Screening Questionnaire for Disaster Mental Health -SQD.
measure: Assessing social support during Italian lockdown
time frame: From March 9 2020 to May 3 2020
description: The study will evaluate social support through questions asking how much during the lockdown period people could count on the support / help of people (e.g. relatives, friends, neighbors, health care professionals, etc).
arm group label: Moli-sani Study sub-cohort
description: A sample of 2,500 men and women from the Moli-sani Study cohort (2005-2010) who were re-examined in 2017-2020. Participants will be contacted by telephone by researchers of the Moli-sani Study recruitment team in order to collect dietary, lifestyle and psychosocial information and assess potential changes possibly occurred during Phase 1 lockdown.
arm group label: Italian general population
description: The project will retrospectively collect data through a web-based survey using Google form. The questionnaire consists of the same items used for the Moli-sani sub-cohort. The project aims at including as many subjects' records as possible.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Licia Iacoviello, MD, PhD
role: Principal Investigator
affiliation: IRCCS Neuromed
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Neuromed IRCCS
investigator full name: Licia Iacoviello
investigator title: Professor
sharing ipd: No