Analysis of Long Term Risk of Coronavirus Disease-19 Emergency (ALTRISCOVID-19)

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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Habits; Lifestyle; Psychosocial Problem

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 4307

Contacts and Locations

Study Locations

• Italy
  • Pozzilli, Italy, 86079
    • IRCCS Neuromed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Moli-sani Study sub-cohort 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. This project will be hereafter referred to as Moli-LOCK Study.

Italian general population The project will retrospectively collect data through a web-based survey using Google form. The questionnaire consists of the same items used in the Moli-LOCK Study. The investigators aim at including as many subjects' records as possible. This project will be hereafter referred to as ALT RISCOVID-19.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Moli-sani Study sub-cohort; 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; 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?

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

Collaborators and Investigators

• Sponsor: Neuromed IRCCS
• Investigators: Principal Investigator: Licia Iacoviello, MD, PhD, IRCCS Neuromed

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: pandemic; lifestyles; lockdown; dietary habits; psychosocial factors
• Other Study ID Numbers: DEP 1/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No