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

N

Neuromed IRCCS

Status

Completed

Conditions

Psychosocial Problem
Dietary Habits
Lifestyle

Study type

Observational

Funder types

Other

Identifiers

NCT04422262
DEP 1/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,307 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

4,307 participants in 2 patient groups

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.
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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