Clinical trial NCT04437121: Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
COVID-19
Keywords: Eating Habits
Sedentary Behavior
Childhood Obesity
Quarantine
COVID-19
School Closings
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 397
Sex: ALL
Minimum age (years): 24
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight (child)
timeFrame: Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
measure: Behaviour (child)
timeFrame: 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:
measure: Behaviour (parents)
timeFrame: Approximately one month before the Greek lockdown period (February 2020) and two months during the quarantine period (23 March 2020 till 24 May 2020)
measure: Physical Activity Levels (child)
timeFrame: 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)
measure: Screen Time (child)
timeFrame: 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)
measure: Sleep Duration (child)
timeFrame: 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)
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: Department of Nutrition-Dietetics
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Odysseas Androutsos, M.Med.Sci., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: