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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2022
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Hypothesis: The eating habits of the population together with physical activity level will change during the COVID-19 outbreak confinement.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Universidad de Granada Granada

Sponsors (17)

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

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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.

Outcome

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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