Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece (COV-EAT)

June 17, 2020 updated by: Odysseas Androutsos, University of Thessaly

Dietary and Lifestyle Habits of Children and Adolescents and Their Parents During the Pandemic of COVID-19 in Greece: The COV-EAT Study

The aim of this study was to examine potential changes in children' and adolescents' dietary and lifestyle (physical activity, sedentary behaviour and sleep) habits during the quarantine that was implemented in Greece due to COVID-19. An online survey in a random sample of families across Greece was conducted. Parents self-reported their children's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since December 2019, the world is facing a new disease (COVID-19), which is caused by the Coronavirus (Sars CoV-2). WHO declared the disease of COVID-19 as a pandemic in February 2020. Since then, many countries around the world have imposed lockdown (quarantine at home), as the main measure to prevent the spreading of the disease. In Greece, the lockdown was officially imposed from March, 23rd, 2020. This unprecedented situation may have caused changes in adults' and children's dietary and lifestyle habits.

Data were collected via an online survey consisting of 70 questions. Study participants were enrolled after signing an informed consent form. The questionnaire self-reported by volunteers (parents of children aged between 2-18 years old). The survey had 3 sections. The first section focused on participants' sociodemographic data (e.g. gender, age, city of residence and socioeconomic level). The second and third sections contained questions about the parents' (section 2) and their children's (section 3) dietary and lifestyle habits before and during quarantine.

The scientific community raises concerns about the health implications that will be caused due to the COVID-19 lockdown. The results of this study are expected to shed light into children and adolescents, as well as their parents', changes in dietary and lifestyle behaviours and feed the development of effective strategies to prevent the adoption of unhealthy lifestyle behaviours and weight gain in the event of a second wave of COVID-19 in the coming months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Tríkala, Thessaly, Greece, 42132
        • Department of Nutrition-Dietetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents of children and adolescents, aged 2-18 years, during the lockdown period due to the COVID-19 pandemic in Greece.

Description

Inclusion Criteria:

  1. Parents of children and adolescents, aged 2-18 years.
  2. During the lockdown period due to the COVID-19 pandemic in Greece.
  3. Parents signed an informed consent form prior to their participation to the study

Exclusion Criteria:

  1. Parents of children <24 months old.
  2. Parents of children >18 years old.
  3. Parents not living in Greece.
  4. Parents who did not sign the consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parents of children aged 2-18 years
Parents of children aged 2-18 years during the lockdown due to the COVID-19 pandemic, following their informed consent form prior to their participation to the study.
Other: Online Survey about Dietary and Lifestyle Habits

An online survey was conducted in a random sample of families. Parents self-reported their child's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.

The survey consisted of 70 questions in 3 sections.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in weight (child)
Time Frame: Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Weight in kg will be measured using scales at home
Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Behaviour (child)
Time Frame: Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Eating Behaviour during the quarantine, measured with an online (FFQ) questionnaire.
Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behaviour (parents)
Time Frame: Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Eating Behaviour during the quarantine, measured with an online questionnaire.
Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Physical Activity Levels (child)
Time Frame: Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Child's physical activity levels during the quarantine period, measured with an online questionnaire.
Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Screen Time (child)
Time Frame: Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Changes in children' screen time (hours per day) during the quarantine period, measured with an online questionnaire.
Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Sleep Duration (child)
Time Frame: Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
Changes in children' sleep time (hours per day) during the quarantine period, measured with an online questionnaire.
Approximately two months before the Greek lockdown period (January-February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Odysseas Androutsos, M.Med.Sci., Ph.D., University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COV-EAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Online Survey about Dietary and Lifestyle Habits

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings