Analysis of Long Term Risk of Coronavirus Disease-19 Emergency
- Conditions
- LifestyleDietary HabitsPsychosocial Problem
- Registration Number
- NCT04422262
- Lead Sponsor
- Neuromed IRCCS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4307
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing changes in physical activity during Italian lockdown From March 9 2020 to May 3 2020 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.Assessing changes in social habits during Italian lockdown From March 9 2020 to May 3 2020 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.Assessing changes in work-related activities during Italian lockdown From March 9 2020 to May 3 2020 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.Assessing changes in smoking status during Italian lockdown From March 9 2020 to May 3 2020 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.
- Secondary Outcome Measures
Name Time Method Assessing anxiety during Italian lockdown From March 9 2020 to May 3 2020 The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7).
Assessing post-traumatic stress disorder during Italian lockdown From March 9 2020 to May 3 2020 The 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 lockdown From March 9 2020 to May 3 2020 The 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 depression during Italian lockdown From March 9 2020 to May 3 2020 The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) .
Assessing stress during Italian lockdown From March 9 2020 to May 3 2020 The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4).
Assessing social support during Italian lockdown From March 9 2020 to May 3 2020 The 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).
Trial Locations
- Locations (1)
IRCCS Neuromed
🇮🇹Pozzilli, Italy