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

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ClinicalTrials.gov Identifier: NCT04449731
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : November 4, 2020
Sponsor:
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

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.

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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

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



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.




Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449731


Contacts
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Contact: Celia Rodríguez Pérez, PhD 0034 958 243869 celiarp@ugr.es
Contact: María Dolores Ruíz López, PhD 0034 958 243869 mdruiz@ugr.es

Locations
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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
Publications of Results:
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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    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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