Analysis of Long Term Risk of Coronavirus Disease-19 Emergency

NCT ID: NCT04422262

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4307 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Lifestyle; Dietary Habits; Psychosocial Problem

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Re-examination in 2017-2020;
• 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.

Exclusion Criteria

• Not able to give verbal consent

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Licia Iacoviello

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Licia Iacoviello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed

Locations

IRCCS Neuromed

Pozzilli, , Italy

Countries

Italy

Other Identifiers

DEP 1/2020

Identifier Type: -

Identifier Source: org_study_id