Analysis of Long Term Risk of Coronavirus Disease-19 Emergency

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of the Italian Lockdown on Lifestyles and Psychosocial Status of the Moli-Sani Study Cohort and the Italian General Population

Conditions
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Lifestyle, Dietary Habits, Psychosocial Problem

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for the Moli-sani Study sub-cohort: Re-examination in 2017-2020; Able to give verbal consent Exclusion criteria for the Moli-sani Study sub-cohort: - Not able to give verbal consent Inclusion Criteria for the General Italian population cohort: Age >= 18 years. All subjects from the general population with access to electronic devices and the Internet (e.g. personal computer, smartphone) and is fluent in Italian will be eligible. Exclusion Criteria for the General Italian population cohort: Subjects younger than 18 years Only people with access to personal computers, smartphones and the Internet, and fluency in Italian will be able to participate. These exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moli-sani Study sub-cohort<br>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. | |
| Italian general population<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing changes in smoking status during Italian lockdown | 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. | From March 9 2020 to May 3 2020 | 
| Assessing changes in physical activity during Italian lockdown | 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. | From March 9 2020 to May 3 2020 | 
| Assessing changes in work-related activities during Italian lockdown | 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. | From March 9 2020 to May 3 2020 | 
| Assessing changes in social habits during Italian lockdown | 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. | From March 9 2020 to May 3 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing changes in dietary habits during Italian lockdown | 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'. | From March 9 2020 to May 3 2020 | 
| Assessing depression during Italian lockdown | The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) . | From March 9 2020 to May 3 2020 | 
| Assessing anxiety during Italian lockdown | The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7). | From March 9 2020 to May 3 2020 | 
| Assessing stress during Italian lockdown | The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4). | From March 9 2020 to May 3 2020 | 
| Assessing post-traumatic stress disorder during Italian lockdown | 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. | From March 9 2020 to May 3 2020 | 
| Assessing social support during Italian lockdown | 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). | From March 9 2020 to May 3 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pandemic, lockdown, lifestyles, dietary habits, psychosocial factors