COVID-19COVIDiet_IntNCT04449731
Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population (COVIDiet_Int)
An observational study of COVID-19, run by Universidad de Granada at 1 site in Spain.
Trial summary
This cross-sectional study will allow to collect eating behaviours data during the COVID-19 confinement, some of them related to the Mediterranean Diet to better understand the eating behaviours of adult population during this novel and exceptional situation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 35,000 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2020to 30 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Around 30000 adults from 22 countries including Bosnia and Herzegovina, Colombia, Croatia, Denmark, Egypt, Germany, Greece, India, Ireland, Italy, Kosovo, Kuwait, Lithuania, Montenegro, North Macedonia, Poland, Portugal, Serbia, Slovenia, Spain, Turkey and United Kingdom.
Who may be able to join
- Adults aged from 18 years old and over living in the countries involved in the study.
Who cannot join
- People under 18 years of age living in countries different from those involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population
This cross-sectional study will allow to collect eating behaviours data during the COVID-19 confinement, some of them related to the Mediterranean Diet to better understand the eating behaviours of adult population during this novel and exceptional situation.
Hypothesis: The eating habits of the population together with physical activity level will change during the COVID-19 outbreak confinement.
Read the detailed description
Around thirty thousand adults (18 years old and older) will be recruited from 22 different countries (i.e. including Bosnia and Herzegovina, Colombia, Croatia, Denmark, Egypt, Germany, Greece, India, Ireland, Italy, Kosovo, Kuwait, Lithuania, Montenegro, North Macedonia, Poland, Portugal, Serbia, Slovenia, Spain, Turkey and United Kingdom). A self-administered web-based questionnaire with questions aimed at assessing the dietary behaviours of the adult population during the COVID-19 confinement and before it started, will be distributed using social media and snowball sampling. The questionnaire is based on 44 items including socio-demographic data, MEditerranean Diet Adherence Screener (MEDAS) as a reference of a healthy diet, processed foods intake, changes in their usual food choices and weight gain. All data will be collected online to reach the largest number of participants from all territories.
The main objectives of this study are: 1) to examine whether the COVID-19 outbreak confinement has influenced eating habits among the adult population from the 22 countries previously detailed, and 2) to assess the differences in eating behaviours between the countries involved in the study to have a global overview of the behaviour in the face of confinement that helps in public health decision making related to positive impact on the prevention of chronic diseases and COVID-19-related complications.
- Conditions
- COVID-19
- Keywords
- Eating behaviours, Mediterranean Diet, COVID-19 confinement, Dietary habits, Physical activity
- Medical subject headings
- COVID-19, Feeding Behavior, Motor Activity
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 |
|---|---|---|
| Adult population (> 18 years old) | Around 30000 adults (> 18 years old) from 22 different countries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean diet before and during the COVID-19 confinement
Part of the questionnaire based on the validated PREDIMED MEditerranean Diet Adherence Screener (MEDAS-14). Briefly, one point is scored when the following choices are selected: olive oil for cooking, daily consumption of four or more tablespoons of olive oil, white meat vs. red meat, two or more servings of vegetables, three or more pieces of fruit, less than one serving of red meat, hamburgers, sausages or deli meats, less than one serving of carbonated or sugary drinks, weekly intake of seven or more glasses of wine, three or more servings of legumes, three or more servings of fish/seafood, three or more servings of nuts, less than two servings of non-homemade pastries, white meat such as turkey or chicken preference instead red meat and two or more dishes seasoned with tomato, garlic, onion or leeks and sautéed with olive oil (sofrito).
The MEDAS-14 score ranges from 0 to 14, whereby higher a scoring reflects greater adherence to the Mediterranean diet.
Measured: 6 months
Eating behaviours
Part of the questionnaire based on changes in frequency of cooking, snacking, alcohol, fast-food intake (higher, lower or similar) and fried foods intake (<1 time a week, 1-3 times a week, 4-6 times a week, 7 or more than 7 times a week, never), type of oil employed for frying (olive oil, sunflower oil or other), number of main daily meals out of home before the confinement (0,1, 2 or 3), difficult finding any type of food (yes/no) or perception of being eating more during the confinement (yes/no).
In this case, better outcomes are expected if participants increase or maintain the frequency of cooking, use olive oil for frying and decrease or maintain the frequency of snacking, alcohol, fast-food or fried foods intake. Additionally, a good outcome will be considered if participants do not eat more during the confinement and if they do not have problems in finding any type of food.
Measured: 6 months
Secondary outcomes (2)
Level of physical activity during the COVID-19 confinement
The questionnaire includes a question regarding the level of physical activity during the COVID-19 confinement in which the following options are provided: it has increased, it has decreased, it remains as usual, I do not practice physical activity.
The best outcome will be considered if the participants maintain or increase their physical activity level during the COVID-19 confinement.
Measured: 6 months
Weight gain during the COVID-19 confinement
The questionnaire includes a question about the perception or weight gain during the confinement (increased/decreased/Unknown).
The best outcome will be considered if the participants do not increase weight during the COVID-19 confinement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start20 Mar 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 35,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Agricultural University of Athens, University of Zagreb, University of Belgrade, Institute of Technology, Sligo, University of Sarajevo, Lithuanian University of Health Sciences, Jozef Stefan Institute, University of Southern Denmark, Institut Za Javno Zdeavlje, University of Skopje, Poznan University of Life Sciences, Bezmialem Vakif University, Unidade Local de Saúde de Coimbra, EPE, Kuwait University, Universidad Nacional de Colombia, Manav Rachna International Institute of Research and Studies
- Responsible party
- Principal investigator, Celia Rodríguez Pérez, Universidad de Granada
- Investigators
- Celia Rodríguez Pérez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449731
- Sponsor's protocol ID
- 1526/CEIH/2020
- Acronym
- COVIDiet_Int
- Status last verified
- Nov 2022
- First submitted
- 23 Jun 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez-Perez C, Molina-Montes E, Verardo V, Artacho R, Garcia-Villanova B, Guerra-Hernandez EJ, Ruiz-Lopez MD. Changes in Dietary Behaviours during the COVID-19 Outbreak Confinement in the Spanish COVIDiet Study. Nutrients. 2020 Jun 10;12(6):1730. doi: 10.3390/nu12061730.
PubMed 32531892Kriaucioniene V, Bagdonaviciene L, Rodriguez-Perez C, Petkeviciene J. Associations between Changes in Health Behaviours and Body Weight during the COVID-19 Quarantine in Lithuania: The Lithuanian COVIDiet Study. Nutrients. 2020 Oct 13;12(10):3119. doi: 10.3390/nu12103119.
PubMed 33065991Giacalone D, Frost MB, Rodriguez-Perez C. Reported Changes in Dietary Habits During the COVID-19 Lockdown in the Danish Population: The Danish COVIDiet Study. Front Nutr. 2020 Dec 8;7:592112. doi: 10.3389/fnut.2020.592112. eCollection 2020.
PubMed 33364250Sulejmani E, Hyseni A, Xhabiri G, Rodriguez-Perez C. Relationship in dietary habits variations during COVID-19 lockdown in Kosovo: The COVIDiet study. Appetite. 2021 Sep 1;164:105244. doi: 10.1016/j.appet.2021.105244. Epub 2021 Apr 10.
PubMed 33848591Pfeifer D, Resetar J, Gajdos Kljusuric J, Panjkota Krbavcic I, Vranesic Bender D, Rodriguez-Perez C, Ruiz-Lopez MD, Satalic Z. Cooking at Home and Adherence to the Mediterranean Diet During the COVID-19 Confinement: The Experience From the Croatian COVIDiet Study. Front Nutr. 2021 Mar 31;8:617721. doi: 10.3389/fnut.2021.617721. eCollection 2021.
PubMed 33869262Pertuz-Cruz SL, Molina-Montes E, Rodriguez-Perez C, Guerra-Hernandez EJ, Cobos de Rangel OP, Artacho R, Verardo V, Ruiz-Lopez MD, Garcia-Villanova B. Exploring Dietary Behavior Changes Due to the COVID-19 Confinement in Colombia: A National and Regional Survey Study. Front Nutr. 2021 Apr 12;8:644800. doi: 10.3389/fnut.2021.644800. eCollection 2021.
PubMed 33912582Molina-Montes E, Uzhova I, Verardo V, Artacho R, Garcia-Villanova B, Jesus Guerra-Hernandez E, Kapsokefalou M, Malisova O, Vlassopoulos A, Katidi A, Korousic Seljak B, Modic R, Eftimov T, Hren I, Valencic E, Satalic Z, Panjkota Krbavcic I, Vranesic Bender D, Giacalone D, Bom Frost M, Konic Ristic A, Milesevic J, Nikolic M, Kolay E, Guney M, Kriaucioniene V, Czlapka-Matyasik M, Bykowska-Derda A, Kujundzic E, Taljic I, Brka M, Spiroski I, Cunha Velho S, Patricia Sousa Pinto S, Nascimento Monteiro I, Adriana Pereira J, Dolores Ruiz-Lopez M, Rodriguez-Perez C. Impact of COVID-19 confinement on eating behaviours across 16 European countries: The COVIDiet cross-national study. Food Qual Prefer. 2021 Oct;93:104231. doi: 10.1016/j.foodqual.2021.104231. Epub 2021 Mar 23.
PubMed 36569642Taljić, I., Brka, M., & Rodríguez-Pérez, C. (2022). Dietary Habits During the COVID-19 Lockdown in Bosnia and Herzegovina's COVIDiet Study. In Central European Congress on Food (pp. 477-485). Springer, Cham.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population
- ClinicalTrials.gov ID
- NCT04449731
- Acronym / sponsor ID
- COVIDiet_Int / 1526/CEIH/2020
- Conditions
- COVID-19
- Keywords
- Eating behaviours, Mediterranean Diet, COVID-19 confinement, Dietary habits, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,000 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Agricultural University of Athens, University of Zagreb, University of Belgrade, Institute of Technology, Sligo, University of Sarajevo, Lithuanian University of Health Sciences, Jozef Stefan Institute, University of Southern Denmark, Institut Za Javno Zdeavlje, University of Skopje, Poznan University of Life Sciences, Bezmialem Vakif University, Unidade Local de Saúde de Coimbra, EPE, Kuwait University, Universidad Nacional de Colombia, Manav Rachna International Institute of Research and Studies
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 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.
This cross-sectional study will allow to collect eating behaviours data during the COVID-19 confinement, some of them related to the Mediterranean Diet to better understand the eating behaviours of adult population during this novel and exceptional situation.
Hypothesis: The eating habits of the population together with physical activity level will change during the COVID-19 outbreak confinement.
Detailed description
Around thirty thousand adults (18 years old and older) will be recruited from 22 different countries (i.e. including Bosnia and Herzegovina, Colombia, Croatia, Denmark, Egypt, Germany, Greece, India, Ireland, Italy, Kosovo, Kuwait, Lithuania, Montenegro, North Macedonia, Poland, Portugal, Serbia, Slovenia, Spain, Turkey and United Kingdom). A self-administered web-based questionnaire with questions aimed at assessing the dietary behaviours of the adult population during the COVID-19 confinement and before it started, will be distributed using social media and snowball sampling. The questionnaire is based on 44 items including socio-demographic data, MEditerranean Diet Adherence Screener (MEDAS) as a reference of a healthy diet, processed foods intake, changes in their usual food choices and weight gain. All data will be collected online to reach the largest number of participants from all territories.
The main objectives of this study are: 1) to examine whether the COVID-19 outbreak confinement has influenced eating habits among the adult population from the 22 countries previously detailed, and 2) to assess the differences in eating behaviours between the countries involved in the study to have a global overview of the behaviour in the face of confinement that helps in public health decision making related to positive impact on the prevention of chronic diseases and COVID-19-related complications.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult population (> 18 years old) | – | –Around 30000 adults (> 18 years old) from 22 different countries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Around 30000 adults from 22 countries including Bosnia and Herzegovina, Colombia, Croatia, Denmark, Egypt, Germany, Greece, India, Ireland, Italy, Kosovo, Kuwait, Lithuania, Montenegro, North Macedonia, Poland, Portugal, Serbia, Slovenia, Spain, Turkey and United Kingdom.
Key inclusion criteria (1 listed)
- Adults aged from 18 years old and over living in the countries involved in the study.
Key exclusion criteria (1 listed)
- People under 18 years of age living in countries different from those involved in the study.
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
Adherence to the Mediterranean diet before and during the COVID-19 confinement
Time frame: 6 months
Part of the questionnaire based on the validated PREDIMED MEditerranean Diet Adherence Screener (MEDAS-14). Briefly, one point is scored when the following choices are selected: olive oil for cooking, daily consumption of four or more tablespoons of olive oil, white meat vs. red meat, two or more servings of vegetables, three or more pieces of fruit, less than one serving of red meat, hamburgers, sausages or deli meats, less than one serving of carbonated or sugary drinks, weekly intake of seven or more glasses of wine, three or more servings of legumes, three or more servings of fish/seafood, three or more servings of nuts, less than two servings of non-homemade pastries, white meat such as turkey or chicken preference instead red meat and two or more dishes seasoned with tomato, garlic, onion or leeks and sautéed with olive oil (sofrito). The MEDAS-14 score ranges from 0 to 14, whereby higher a scoring reflects greater adherence to the Mediterranean diet.
Eating behaviours
Time frame: 6 months
Part of the questionnaire based on changes in frequency of cooking, snacking, alcohol, fast-food intake (higher, lower or similar) and fried foods intake (<1 time a week, 1-3 times a week, 4-6 times a week, 7 or more than 7 times a week, never), type of oil employed for frying (olive oil, sunflower oil or other), number of main daily meals out of home before the confinement (0,1, 2 or 3), difficult finding any type of food (yes/no) or perception of being eating more during the confinement (yes/no). In this case, better outcomes are expected if participants increase or maintain the frequency of cooking, use olive oil for frying and decrease or maintain the frequency of snacking, alcohol, fast-food or fried foods intake. Additionally, a good outcome will be considered if participants do not eat more during the confinement and if they do not have problems in finding any type of food.
2 secondary outcomes
Level of physical activity during the COVID-19 confinement
Time frame: 6 months
Weight gain during the COVID-19 confinement
Time frame: 6 months
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 4 Nov 2022.
- Results publication: PubMed 32531892Rodriguez-Perez C, Molina-Montes E, Verardo V, Artacho R, Garcia-Villanova B, Guerra-Hernandez EJ, Ruiz-Lopez MD. Changes in Dietary Behaviours during the COVID-19 Outbreak Confinement in the Spanish COVIDiet Study. Nutrients. 2020 Jun 10;12(6):1730. doi: 10.3390/nu12061730.
- Results publication: PubMed 33065991Kriaucioniene V, Bagdonaviciene L, Rodriguez-Perez C, Petkeviciene J. Associations between Changes in Health Behaviours and Body Weight during the COVID-19 Quarantine in Lithuania: The Lithuanian COVIDiet Study. Nutrients. 2020 Oct 13;12(10):3119. doi: 10.3390/nu12103119.
- Results publication: PubMed 33364250Giacalone D, Frost MB, Rodriguez-Perez C. Reported Changes in Dietary Habits During the COVID-19 Lockdown in the Danish Population: The Danish COVIDiet Study. Front Nutr. 2020 Dec 8;7:592112. doi: 10.3389/fnut.2020.592112. eCollection 2020.
- Results publication: PubMed 33848591Sulejmani E, Hyseni A, Xhabiri G, Rodriguez-Perez C. Relationship in dietary habits variations during COVID-19 lockdown in Kosovo: The COVIDiet study. Appetite. 2021 Sep 1;164:105244. doi: 10.1016/j.appet.2021.105244. Epub 2021 Apr 10.
- Results publication: PubMed 33869262Pfeifer D, Resetar J, Gajdos Kljusuric J, Panjkota Krbavcic I, Vranesic Bender D, Rodriguez-Perez C, Ruiz-Lopez MD, Satalic Z. Cooking at Home and Adherence to the Mediterranean Diet During the COVID-19 Confinement: The Experience From the Croatian COVIDiet Study. Front Nutr. 2021 Mar 31;8:617721. doi: 10.3389/fnut.2021.617721. eCollection 2021.
- Results publication: PubMed 33912582Pertuz-Cruz SL, Molina-Montes E, Rodriguez-Perez C, Guerra-Hernandez EJ, Cobos de Rangel OP, Artacho R, Verardo V, Ruiz-Lopez MD, Garcia-Villanova B. Exploring Dietary Behavior Changes Due to the COVID-19 Confinement in Colombia: A National and Regional Survey Study. Front Nutr. 2021 Apr 12;8:644800. doi: 10.3389/fnut.2021.644800. eCollection 2021.
- Results publication: PubMed 36569642Molina-Montes E, Uzhova I, Verardo V, Artacho R, Garcia-Villanova B, Jesus Guerra-Hernandez E, Kapsokefalou M, Malisova O, Vlassopoulos A, Katidi A, Korousic Seljak B, Modic R, Eftimov T, Hren I, Valencic E, Satalic Z, Panjkota Krbavcic I, Vranesic Bender D, Giacalone D, Bom Frost M, Konic Ristic A, Milesevic J, Nikolic M, Kolay E, Guney M, Kriaucioniene V, Czlapka-Matyasik M, Bykowska-Derda A, Kujundzic E, Taljic I, Brka M, Spiroski I, Cunha Velho S, Patricia Sousa Pinto S, Nascimento Monteiro I, Adriana Pereira J, Dolores Ruiz-Lopez M, Rodriguez-Perez C. Impact of COVID-19 confinement on eating behaviours across 16 European countries: The COVIDiet cross-national study. Food Qual Prefer. 2021 Oct;93:104231. doi: 10.1016/j.foodqual.2021.104231. Epub 2021 Mar 23.
- Results publicationTaljić, I., Brka, M., & Rodríguez-Pérez, C. (2022). Dietary Habits During the COVID-19 Lockdown in Bosnia and Herzegovina's COVIDiet Study. In Central European Congress on Food (pp. 477-485). Springer, Cham.
- 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.
Celia Rodríguez Pérez, PhD principal investigator
Universidad de Granada
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 COVID-19, run by Universidad de Granada at 1 site in Spain.
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 1 inclusion and 1 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 4 Nov 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 Spain. 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?
Adherence to the Mediterranean diet before and during the COVID-19 confinement (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449731, which also lists 8 linked publications.
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 4 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.