Eating BehaviorCOV-EATNCT04437121
Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece
An observational study of Eating Behavior and COVID-19, run by University of Thessaly at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, COVID-19
- What is being tested?
- Online Survey about Dietary and Lifestyle Habits
- How many people
- 397 participants
- Where
- 1 siteGreece
- Study dates
- 30 Apr 2020to 24 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Parents of children and adolescents, aged 2-18 years, during the lockdown period due to the COVID-19 pandemic in Greece.
Who may be able to join
- Parents of children and adolescents, aged 2-18 years.
- During the lockdown period due to the COVID-19 pandemic in Greece.
- Parents signed an informed consent form prior to their participation to the study
Who cannot join
- Parents of children <24 months old.
- Parents of children >18 years old.
- Parents not living in Greece.
- Parents who did not sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Behavior, COVID-19
- Being tested
- Online Survey about Dietary and Lifestyle Habits
- Keywords
- Eating Habits, Sedentary Behavior, Childhood Obesity, Quarantine, COVID-19, School Closings
- Medical subject headings
- Feeding Behavior, COVID-19, Sedentary Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Survey about Dietary and Lifestyle HabitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Online Survey about Dietary and Lifestyle Habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (child)
Weight in kg will be measured using scales at home
Measured: 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)
Eating Behaviour during the quarantine, measured with an online (FFQ) questionnaire.
Measured: 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 outcomes (4)
Behaviour (parents)
Eating Behaviour during the quarantine, measured with an online questionnaire.
Measured: 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)
Child's physical activity levels during the quarantine period, measured with an online questionnaire.
Measured: 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)
Changes in children' screen time (hours per day) during the quarantine period, measured with an online questionnaire.
Measured: 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)
Changes in children' sleep time (hours per day) during the quarantine period, measured with an online questionnaire.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start30 Apr 2020
- Primary completion24 May 2020
- Study completion24 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odysseas Androutsos, University of Thessaly
- Investigators
- Odysseas Androutsos, M.Med.Sci., Ph.D., Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437121
- Sponsor's protocol ID
- COV-EAT
- Acronym
- COV-EAT
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary and Lifestyle Habits of Children and Adolescents and Their Parents During the Pandemic of COVID-19 in Greece: The COV-EAT Study
- ClinicalTrials.gov ID
- NCT04437121
- Acronym / sponsor ID
- COV-EAT / COV-EAT
- Conditions
- Eating Behavior, COVID-19
- Keywords
- Eating Habits, Sedentary Behavior, Childhood Obesity, Quarantine, COVID-19, School Closings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 24 May 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of children aged 2-18 years | – | Other: Online Survey about Dietary and Lifestyle HabitsParents 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. |
Who may qualify
- Ages
- 24 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Parents of children and adolescents, aged 2-18 years, during the lockdown period due to the COVID-19 pandemic in Greece.
Key inclusion criteria (3 listed)
- Parents of children and adolescents, aged 2-18 years.
- During the lockdown period due to the COVID-19 pandemic in Greece.
- Parents signed an informed consent form prior to their participation to the study
Key exclusion criteria (4 listed)
- Parents of children <24 months old.
- Parents of children >18 years old.
- Parents not living in Greece.
- Parents who did not sign the consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Survey about Dietary and Lifestyle HabitsAn 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. | Other | Parents of children aged 2-18 years |
Primary outcome
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
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: Undecided. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odysseas Androutsos, M.Med.Sci., Ph.D. principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behavior and COVID-19, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.