Clinical trial NCT04422262: Analysis of Long Term Risk of Coronavirus Disease-19 Emergency
Official title: Impact of the Italian Lockdown on Lifestyles and Psychosocial Status of the Moli-Sani Study Cohort and the Italian General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lifestyle
Dietary Habits
Psychosocial Problem
Keywords: pandemic
lockdown
lifestyles
dietary habits
psychosocial factors
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 4307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessing changes in smoking status during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing changes in physical activity during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing changes in work-related activities during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing changes in social habits during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
Secondary outcomes:
measure: Assessing changes in dietary habits during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing depression during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing anxiety during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing stress during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing post-traumatic stress disorder during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
measure: Assessing social support during Italian lockdown
timeFrame: From March 9 2020 to May 3 2020
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: IRCCS Neuromed
name: Licia Iacoviello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: