Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population (COVIDiet_Int) (COVIDiet_Int)

• ClinicalTrials.gov Identifier: NCT04449731
• Recruitment Status: Recruiting
• First Posted: June 29, 2020
• Last Update Posted: November 4, 2020
• Sponsor: Universidad de Granada
• 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; Centro Hospitalar e Universitário de Coimbra, E.P.E.; Kuwait University; Universidad Nacional de Colombia; Manay Rachna International institute of Research and Studies
• Information provided by (Responsible Party): Celia Rodríguez Pérez, Universidad de Granada

Study Description

Brief 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.

Condition or disease
COVID-19

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

• Study Type: Observational
• Estimated Enrollment: 30000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population
• Actual Study Start Date: March 20, 2020
• Actual Primary Completion Date: August 30, 2020
• Estimated Study Completion Date: June 30, 2021

Groups and Cohorts

Group/Cohort
Adult population (> 18 years old); Around 30000 adults (> 18 years old) from 22 different countries.

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Secondary Outcome Measures :

1. Level of physical activity during the COVID-19 confinement [ Time Frame: 6 months ]

   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.

2. Weight gain during the COVID-19 confinement [ Time Frame: 6 months ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Celia Rodríguez Pérez, PhD; 0034 958 243869; celiarp@ugr.es

Contact: María Dolores Ruíz López, PhD; 0034 958 243869; mdruiz@ugr.es

Locations

Spain

Universidad de Granada; Recruiting

Granada, Spain, 18011

Contact: Celia Rodríguez-Pérez, PhD 958 243869 celiarp@ugr.es

Contact: María Dolores Ruíz-López, PhD 958 243869 mdruiz@ugr.es

Principal Investigator: Celia Rodríguez-Pérez, PhD

Sub-Investigator: María Dolores Ruíz-López, PhD

Sub-Investigator: Reyes Artacho Martín-Lagos, PhD

Sub-Investigator: Esther Molina-Montes, PhD

Sub-Investigator: Belén García-Villanova Ruíz, PhD

Sub-Investigator: Eduardo Jesús Guerra-Hernández, PhD

Sub-Investigator: Vito Verardo, PhD

Sponsors and Collaborators

Universidad de Granada

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

Centro Hospitalar e Universitário de Coimbra, E.P.E.

Kuwait University

Universidad Nacional de Colombia

Manay Rachna International institute of Research and Studies

More Information

Publications of Results:

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: E1730. doi: 10.3390/nu12061730.

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. doi: 10.3390/nu12103119.

• Responsible Party: Celia Rodríguez Pérez, Assistant Professor in Nutrition and Food Science, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT04449731
• Other Study ID Numbers: 1526/CEIH/2020
• First Posted: June 29, 2020
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celia Rodríguez Pérez, Universidad de Granada:

Eating behaviours; Mediterranean Diet; COVID-19 confinement; Dietary habits; Physical activity