LifestyleALTRISCOVID-19NCT04422262
Analysis of Long Term Risk of Coronavirus Disease-19 Emergency
An observational study of Lifestyle and Dietary Habits, run by Neuromed IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lifestyle, Dietary Habits, Psychosocial Problem
- How many people
- 4,307 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jun 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Re-examination in 2017-2020;
- Able to give verbal consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Italian Lockdown on Lifestyles and Psychosocial Status of the Moli-Sani Study Cohort and the Italian General Population
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.
Read the 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
- Keywords
- pandemic, lockdown, lifestyles, dietary habits, psychosocial factors
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing changes in smoking status during Italian lockdown
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.
Measured: From March 9 2020 to May 3 2020
Assessing changes in physical activity during Italian lockdown
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.
Measured: From March 9 2020 to May 3 2020
Assessing changes in work-related activities during Italian lockdown
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.
Measured: From March 9 2020 to May 3 2020
Assessing changes in social habits during Italian lockdown
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.
Measured: From March 9 2020 to May 3 2020
Secondary outcomes (6)
Assessing changes in dietary habits during Italian lockdown
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'.
Measured: From March 9 2020 to May 3 2020
Assessing depression during Italian lockdown
The study will evaluate potential development of depressive symptoms during the Italian lockdown by administering the Patient Health Questionnaire- 9 (PHQ-9) .
Measured: From March 9 2020 to May 3 2020
Assessing anxiety during Italian lockdown
The study will evaluate potential onset of anxiety during the Italian lockdown by administering the Generalized Anxiety Disorder scale (GAD-7).
Measured: From March 9 2020 to May 3 2020
Assessing stress during Italian lockdown
The study will evaluate potential onset of stress during the Italian lockdown by administering the Perceived stress scale (PSS-4).
Measured: From March 9 2020 to May 3 2020
Assessing post-traumatic stress disorder during Italian lockdown
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.
Measured: From March 9 2020 to May 3 2020
Assessing social support during Italian lockdown
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).
Measured: From March 9 2020 to May 3 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jun 2020
- Primary completion31 May 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Iacoviello, Neuromed IRCCS
- Investigators
- Licia Iacoviello, MD, PhD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422262
- Sponsor's protocol ID
- DEP 1/2020
- Acronym
- ALTRISCOVID-19
- Status last verified
- Jan 2022
- First submitted
- 24 May 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Italian Lockdown on Lifestyles and Psychosocial Status of the Moli-Sani Study Cohort and the Italian General Population
- ClinicalTrials.gov ID
- NCT04422262
- Acronym / sponsor ID
- ALTRISCOVID-19 / DEP 1/2020
- Conditions
- Lifestyle, Dietary Habits, Psychosocial Problem
- Keywords
- pandemic, lockdown, lifestyles, dietary habits, psychosocial factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,307 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Re-examination in 2017-2020;
- Able to give verbal consent
Key exclusion criteria (7 listed)
- Not 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessing changes in smoking status during Italian lockdown
Time frame: 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.
Assessing changes in physical activity during Italian lockdown
Time frame: 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 work-related activities during Italian lockdown
Time frame: 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 social habits during Italian lockdown
Time frame: 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.
6 secondary outcomes
Assessing changes in dietary habits during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Assessing depression during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Assessing anxiety during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Assessing stress during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Assessing post-traumatic stress disorder during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Assessing social support during Italian lockdown
Time frame: From March 9 2020 to May 3 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Licia Iacoviello, MD, PhD principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lifestyle and Dietary Habits, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing changes in smoking status during Italian lockdown (time frame: From March 9 2020 to May 3 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.