COVID-19 Clinical Trial
— COVIDiet_IntOfficial title:
Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population
| NCT number | NCT04449731 |
| Other study ID # | 1526/CEIH/2020 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 20, 2020 |
| Est. completion date | June 30, 2021 |
| Verified date | November 2022 |
| Source | Universidad de Granada |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 35000 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | June 30, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adults aged from 18 years old and over living in the countries involved in the study. Exclusion Criteria: - People under 18 years of age living in countries different from those involved in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universidad de Granada | Granada |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad de Granada | Agricultural University of Athens, Bezmialem Vakif University, Centro Hospitalar e Universitário de Coimbra, E.P.E., Institut Za Javno Zdeavlje, Institute of Technology, Sligo, Jozef Stefan Institute, Kuwait University, Lithuanian University of Health Sciences, Manay Rachna International institute of Research and Studies, Poznan University of Life Sciences, Universidad Nacional de Colombia, University of Belgrade, University of Sarajevo, University of Skopje, University of Southern Denmark, University of Zagreb |
Spain,
Giacalone D, Frøst MB, Rodríguez-Pérez 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. — View Citation
Kriaucioniene V, Bagdonaviciene L, Rodríguez-Pérez 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). pii: E3119. — View Citation
Molina-Montes, E., Uzhova, I., Verardo, V., Artacho, R., García-Villanova, B., Guerra-Hernández, E. J., ... & Rodríguez-Pérez, C. Impact of COVID-19 confinement on eating behaviours across 16 European countries: The COVIDiet cross-national study. Food Qua
Pertuz-Cruz SL, Molina-Montes E, Rodríguez-Pérez C, Guerra-Hernández EJ, Cobos de Rangel OP, Artacho R, Verardo V, Ruiz-Lopez MD, García-Villanova B. Exploring Dietary Behavior Changes Due to the COVID-19 Confinement in Colombia: A National and Regional S — View Citation
Pfeifer D, Rešetar J, Gajdoš Kljusuric J, Panjkota Krbavcic I, Vranešic Bender D, Rodríguez-Pérez C, Ruíz-López MD, Šatalic Z. Cooking at Home and Adherence to the Mediterranean Diet During the COVID-19 Confinement: The Experience From the Croatian COVIDi — View Citation
Rodríguez-Pérez C, Molina-Montes E, Verardo V, Artacho R, García-Villanova B, Guerra-Hernández EJ, Ruíz-López MD. Changes in Dietary Behaviours during the COVID-19 Outbreak Confinement in the Spanish COVIDiet Study. Nutrients. 2020 Jun 10;12(6). pii: E173 — View Citation
Sulejmani E, Hyseni A, Xhabiri G, Rodríguez-Pérez 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. — View Citation
Taljic, 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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
6 months | |
| Primary | 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. |
6 months | |
| Secondary | 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. |
6 months | |
| Secondary | 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. |
6 months |
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