<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437121</url>
  </required_header>
  <id_info>
    <org_study_id>COV-EAT</org_study_id>
    <nct_id>NCT04437121</nct_id>
  </id_info>
  <brief_title>Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece</brief_title>
  <acronym>COV-EAT</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to examine potential changes in children' and adolescents' dietary&#xD;
      and lifestyle (physical activity, sedentary behaviour and sleep) habits during the quarantine&#xD;
      that was implemented in Greece due to COVID-19. An online survey in a random sample of&#xD;
      families across Greece was conducted. Parents self-reported their children's and their own&#xD;
      dietary and lifestyle habits, as well as information about their sociodemographic status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since December 2019, the world is facing a new disease (COVID-19), which is caused by the&#xD;
      Coronavirus (Sars CoV-2). WHO declared the disease of COVID-19 as a pandemic in February&#xD;
      2020. Since then, many countries around the world have imposed lockdown (quarantine at home),&#xD;
      as the main measure to prevent the spreading of the disease. In Greece, the lockdown was&#xD;
      officially imposed from March, 23rd, 2020. This unprecedented situation may have caused&#xD;
      changes in adults' and children's dietary and lifestyle habits.&#xD;
&#xD;
      Data were collected via an online survey consisting of 70 questions. Study participants were&#xD;
      enrolled after signing an informed consent form. The questionnaire self-reported by&#xD;
      volunteers (parents of children aged between 2-18 years old). The survey had 3 sections. The&#xD;
      first section focused on participants' sociodemographic data (e.g. gender, age, city of&#xD;
      residence and socioeconomic level). The second and third sections contained questions about&#xD;
      the parents' (section 2) and their children's (section 3) dietary and lifestyle habits before&#xD;
      and during quarantine.&#xD;
&#xD;
      The scientific community raises concerns about the health implications that will be caused&#xD;
      due to the COVID-19 lockdown. The results of this study are expected to shed light into&#xD;
      children and adolescents, as well as their parents', changes in dietary and lifestyle&#xD;
      behaviours and feed the development of effective strategies to prevent the adoption of&#xD;
      unhealthy lifestyle behaviours and weight gain in the event of a second wave of COVID-19 in&#xD;
      the coming months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Actual">May 24, 2020</completion_date>
  <primary_completion_date type="Actual">May 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight (child)</measure>
    <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)</time_frame>
    <description>Weight in kg will be measured using scales at home</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behaviour (child)</measure>
    <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)</time_frame>
    <description>Eating Behaviour during the quarantine, measured with an online (FFQ) questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behaviour (parents)</measure>
    <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)</time_frame>
    <description>Eating Behaviour during the quarantine, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Levels (child)</measure>
    <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)</time_frame>
    <description>Child's physical activity levels during the quarantine period, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screen Time (child)</measure>
    <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)</time_frame>
    <description>Changes in children' screen time (hours per day) during the quarantine period, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Duration (child)</measure>
    <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)</time_frame>
    <description>Changes in children' sleep time (hours per day) during the quarantine period, measured with an online questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">397</enrollment>
  <condition>Eating Behavior</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Parents of children aged 2-18 years</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online Survey about Dietary and Lifestyle Habits</intervention_name>
    <description>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.&#xD;
The survey consisted of 70 questions in 3 sections.</description>
    <arm_group_label>Parents of children aged 2-18 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parents of children and adolescents, aged 2-18 years, during the lockdown period due to the&#xD;
        COVID-19 pandemic in Greece.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parents of children and adolescents, aged 2-18 years.&#xD;
&#xD;
          2. During the lockdown period due to the COVID-19 pandemic in Greece.&#xD;
&#xD;
          3. Parents signed an informed consent form prior to their participation to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parents of children &lt;24 months old.&#xD;
&#xD;
          2. Parents of children &gt;18 years old.&#xD;
&#xD;
          3. Parents not living in Greece.&#xD;
&#xD;
          4. Parents who did not sign the consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Odysseas Androutsos, M.Med.Sci., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Thessaly</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition-Dietetics</name>
      <address>
        <city>Tríkala</city>
        <state>Thessaly</state>
        <zip>42132</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Odysseas Androutsos</investigator_full_name>
    <investigator_title>Odysseas Androutsos, M.Med.Sci., Ph.D. Associate Professor, Department of Nutrition-Dietetics, Univ. of Thessaly</investigator_title>
  </responsible_party>
  <keyword>Eating Habits</keyword>
  <keyword>Sedentary Behavior</keyword>
  <keyword>Childhood Obesity</keyword>
  <keyword>Quarantine</keyword>
  <keyword>COVID-19</keyword>
  <keyword>School Closings</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04437121/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>November 2, 2022</submitted>
    <returned>September 14, 2023</returned>
    <submitted>September 15, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437121
org study id: COV-EAT
nct id: NCT04437121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Crossover
time perspective: Cross-Sectional
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)
description: Weight in kg will be measured using scales at home
measure: 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)
description: Eating Behaviour during the quarantine, measured with an online (FFQ) questionnaire.
measure: 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)
description: Eating Behaviour during the quarantine, measured with an online questionnaire.
measure: 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)
description: Child's physical activity levels during the quarantine period, measured with an online questionnaire.
measure: 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)
description: Changes in children' screen time (hours per day) during the quarantine period, measured with an online questionnaire.
measure: 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)
description: Changes in children' sleep time (hours per day) during the quarantine period, measured with an online questionnaire.
arm group label: Parents of children aged 2-18 years
description: 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.
intervention type: Other
intervention name: Online Survey about Dietary and Lifestyle Habits
description: 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.
arm group label: Parents of children aged 2-18 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Odysseas Androutsos, M.Med.Sci., Ph.D.
role: Principal Investigator
affiliation: University of Thessaly
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Odysseas Androutsos
investigator title: Odysseas Androutsos, M.Med.Sci., Ph.D. Associate Professor, Department of Nutrition-Dietetics, Univ. of Thessaly
mesh term: COVID-19
sharing ipd: Undecided
ipd description: All IPD that underlie results in a publication
provided document: 
submitted: November 2, 2022
returned: September 14, 2023
submitted: September 15, 2023