Analysis of Long Term Risk of Coronavirus Disease-19 Emergency

NCT04422262 | Completed

• 1 other identifier: DEP 1/2020
• Study Type: observational
• Target: 4,307
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lifestyle; Dietary Habits; Psychosocial Problem

Keywords

pandemic; lockdown; lifestyles; dietary habits; psychosocial factors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Assessing changes in dietary habits during Italian lockdown

  From March 9 2020 to May 3 2020

• Assessing depression during Italian lockdown

  From March 9 2020 to May 3 2020

• Assessing anxiety during Italian lockdown

  From March 9 2020 to May 3 2020

• Assessing stress during Italian lockdown

  From March 9 2020 to May 3 2020

• Assessing post-traumatic stress disorder during Italian lockdown

  From March 9 2020 to May 3 2020

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Re-examination in 2017-2020;
• Able to give verbal consent

You may not qualify if:

• \- Not able to give verbal consent
• 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.
• Subjects younger than 18 years

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, 86079, Italy

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Licia Iacoviello, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 9, 2020
• Study Start: June 8, 2020
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)