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Analysis of Long Term Risk of Coronavirus Disease-19 Emergency

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04422262
Acronym
ALTRISCOVID-19
Enrollment
4307
Registered
2020-06-09
Start date
2020-06-08
Completion date
2021-12-31
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits, Lifestyle, Psychosocial Problem

Keywords

pandemic, lockdown, lifestyles, dietary habits, psychosocial factors

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.

Interventions

None listed

Sponsors

Neuromed IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessing changes in smoking status during Italian lockdownFrom March 9 2020 to May 3 2020The 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.
Assessing changes in physical activity during Italian lockdownFrom March 9 2020 to May 3 2020The 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.
Assessing changes in work-related activities during Italian lockdownFrom March 9 2020 to May 3 2020The 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.
Assessing changes in social habits during Italian lockdownFrom March 9 2020 to May 3 2020The 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.

Secondary

MeasureTime frameDescription
Assessing post-traumatic stress disorder during Italian lockdownFrom March 9 2020 to May 3 2020The study will evaluate potential onset of post-traumatic stress disorder during the Italian lockdown by administering the Screening Questionnaire for Disaster Mental Health -SQD.
Assessing changes in dietary habits during Italian lockdownFrom March 9 2020 to May 3 2020The 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'.
Assessing social support during Italian lockdownFrom March 9 2020 to May 3 2020The 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).
Assessing depression during Italian lockdownFrom March 9 2020 to May 3 2020The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) .
Assessing anxiety during Italian lockdownFrom March 9 2020 to May 3 2020The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7).
Assessing stress during Italian lockdownFrom March 9 2020 to May 3 2020The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026