<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/NCT04411511</url>
  </required_header>
  <id_info>
    <org_study_id>2020-1330</org_study_id>
    <nct_id>NCT04411511</nct_id>
  </id_info>
  <brief_title>COVID-19, Obesity and Lifestyle in Children</brief_title>
  <acronym>COLC</acronym>
  <official_title>The Influence of the Covid-19 Pandemia on the Health Behaviour of Primary School Children (and Their Parents) - COVID-19, Obesity and Lifestyle in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle&#xD;
      in Dutch children between 4 - 18 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The threat of the severe acute respiratory syndrome coronavirus (SARS-CoV-2, from here onward&#xD;
      mentioned as COVID-19) and the national measures to restrict transmission of COVID-19 in the&#xD;
      Dutch population have caused a radical change in the daily life of Dutch citizens. Closing of&#xD;
      schools and public locations, even as the public order for social distancing and&#xD;
      self-isolation, is affecting the daily structure and lifestyle habits of Dutch children&#xD;
      greatly. These radical changes in the current situation could yield important information&#xD;
      regarding the health behaviour of children and their families. Knowledge of these changes and&#xD;
      their effects on the health behaviour of these children and their families could influence&#xD;
      future interventions and regulations regarding health behaviour. Current (preliminary)&#xD;
      prevalence figures show that up to 80% of patients infected with COVID-19 are overweight or&#xD;
      obese, indicating that being overweight or obese could be a potential adverse predisposition&#xD;
      in the course of a COVID-19 infection. In the light of this (and possible future) pandemic,&#xD;
      it is important to investigate the effects of the COVID-19 pandemic on the health behaviour&#xD;
      i.e. lifestyle of children (aged between 4 and 18 years) and their families and especially&#xD;
      the effects on possible weight gain during the COVID-19 pandemic. Earlier studies&#xD;
      demonstrated that in particular children with overweight/obesity gain weight in situations&#xD;
      when schools close such as during summer holidays and also during (economic) crisis. It is of&#xD;
      importance to investigate the effects of the Corona-crisis in particular in these children&#xD;
      with a high health risk.&#xD;
&#xD;
      This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle&#xD;
      in lean children and children with overweight and obesity. It evaluates differences in&#xD;
      subgroups, e.a. lean/overweight children, socio-economic status, gender and age.&#xD;
&#xD;
      Study design is a mixed-methods study. Children and/or parents will receive online&#xD;
      questionnaires regarding lifestyle during governemantal measures due to the Covid-19&#xD;
      pandemic, such as closure of schools and sportclubs.&#xD;
&#xD;
      In addition, several children and parents will be interviewed about the changes in lifestyle,&#xD;
      and their needs for working on lifestyle, during the pandemic, for in-depth qualitative&#xD;
      information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 6, 2020</start_date>
  <completion_date type="Anticipated">December 12, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 12, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight child</measure>
    <time_frame>Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in weight parents</measure>
    <time_frame>Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: &quot;coronacrisis-period&quot;). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating behaviour</measure>
    <time_frame>Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms</measure>
    <time_frame>Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day structure</measure>
    <time_frame>Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Daystructure of children during the coronacrisis, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screentime</measure>
    <time_frame>Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Screentime during the the coronacrisis, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Online possibilities</measure>
    <time_frame>Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the &quot;measures&quot;-period, 1 follow-up moment.</time_frame>
    <description>Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life in children</measure>
    <time_frame>Once in first month of the study and once within three months after COVID-19 measures are scaled down.</time_frame>
    <description>Quality of life during the coronacrisis, measured with the Kidscreen-27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting practices</measure>
    <time_frame>Once in first month of the study and once within three months after COVID-19 measures are scaled down.</time_frame>
    <description>Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative data on lifestyle in children</measure>
    <time_frame>Up to approximately 1 year</time_frame>
    <description>Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Covid-19</condition>
  <condition>Obesity, Childhood</condition>
  <condition>Lifestyle</condition>
  <condition>Lifestyle, Healthy</condition>
  <condition>Overweight, Childhood</condition>
  <condition>Children, Only</condition>
  <condition>Family</condition>
  <arm_group>
    <arm_group_label>Lean children</arm_group_label>
    <description>Children between 4-18 years, living in the Netherlands.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with overweight or obesity</arm_group_label>
    <description>Children between 4-18 years, living in the Netherlands. Besides inclusion from the general population, childhood expertise centres will contact their patients to pay attention to this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure to the Dutch measures due to the Covid-19 pandemic.</intervention_name>
    <description>Several measures are taken in The Netherlands, due to the Covid-19 virus and pandemic. For example, closure of schools and sportclubs, and advices to stay at home as much as possible. During the pandemic, several measures also will be scaled down.</description>
    <arm_group_label>Children with overweight or obesity</arm_group_label>
    <arm_group_label>Lean children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children (boys and girls, aged between 4 and 18 years) and their parents living in the&#xD;
        Netherlands.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between 4 - 18 years.&#xD;
&#xD;
          -  Living in The Netherlands.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No signed informed consent by relevant parties (parents of children aged below 12&#xD;
             years, parents and or children aged between 12 and 16 years, or children aged 16 years&#xD;
             and older)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anita CE Vreugdenhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anita CE Vreugdenhil, dr.</last_name>
    <phone>0031433875284</phone>
    <email>a.vreugdenhil@mumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisanne Arayess, drs.</last_name>
    <phone>0031433875284</phone>
    <email>lisanne.arayess@mumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>5800</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anita CE Vreugdenhil, Dr.</last_name>
      <phone>0031433875284</phone>
      <email>a.vreugdenhil@mumc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Lisanne Arayess, Drs.</last_name>
      <phone>31433875284</phone>
      <email>lisanne.arayess@mumc.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Lisanne Arayess, Drs.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Judith W Lubrecht, Drs.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gabrielle L ten Velde, Drs.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>February 16, 2022</last_update_submitted>
  <last_update_submitted_qc>February 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>lifestyle</keyword>
  <keyword>pandemic</keyword>
  <keyword>covid-19</keyword>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04411511
org study id: 2020-1330
nct id: NCT04411511
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle
      in Dutch children between 4 - 18 years.
The threat of the severe acute respiratory syndrome coronavirus (SARS-CoV-2, from here onward
      mentioned as COVID-19) and the national measures to restrict transmission of COVID-19 in the
      Dutch population have caused a radical change in the daily life of Dutch citizens. Closing of
      schools and public locations, even as the public order for social distancing and
      self-isolation, is affecting the daily structure and lifestyle habits of Dutch children
      greatly. These radical changes in the current situation could yield important information
      regarding the health behaviour of children and their families. Knowledge of these changes and
      their effects on the health behaviour of these children and their families could influence
      future interventions and regulations regarding health behaviour. Current (preliminary)
      prevalence figures show that up to 80% of patients infected with COVID-19 are overweight or
      obese, indicating that being overweight or obese could be a potential adverse predisposition
      in the course of a COVID-19 infection. In the light of this (and possible future) pandemic,
      it is important to investigate the effects of the COVID-19 pandemic on the health behaviour
      i.e. lifestyle of children (aged between 4 and 18 years) and their families and especially
      the effects on possible weight gain during the COVID-19 pandemic. Earlier studies
      demonstrated that in particular children with overweight/obesity gain weight in situations
      when schools close such as during summer holidays and also during (economic) crisis. It is of
      importance to investigate the effects of the Corona-crisis in particular in these children
      with a high health risk.

      This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle
      in lean children and children with overweight and obesity. It evaluates differences in
      subgroups, e.a. lean/overweight children, socio-economic status, gender and age.

      Study design is a mixed-methods study. Children and/or parents will receive online
      questionnaires regarding lifestyle during governemantal measures due to the Covid-19
      pandemic, such as closure of schools and sportclubs.

      In addition, several children and parents will be interviewed about the changes in lifestyle,
      and their needs for working on lifestyle, during the pandemic, for in-depth qualitative
      information.
observational model: Cohort
time perspective: Prospective
measure: Change in weight child
time frame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.
measure: Change in weight parents
time frame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: "coronacrisis-period"). Three months after the "measures"-period, 1 follow-up moment.
description: Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.
measure: Eating behaviour
time frame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.
measure: Symptoms
time frame: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.
measure: Day structure
time frame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: Daystructure of children during the coronacrisis, measured with an online questionnaire.
measure: Physical activity
time frame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.
measure: Screentime
time frame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: Screentime during the the coronacrisis, measured with an online questionnaire.
measure: Online possibilities
time frame: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.
description: Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.
measure: Quality of life in children
time frame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
description: Quality of life during the coronacrisis, measured with the Kidscreen-27.
measure: Parenting practices
time frame: Once in first month of the study and once within three months after COVID-19 measures are scaled down.
description: Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.
measure: Qualitative data on lifestyle in children
time frame: Up to approximately 1 year
description: Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.
arm group label: Lean children
description: Children between 4-18 years, living in the Netherlands.
arm group label: Children with overweight or obesity
description: Children between 4-18 years, living in the Netherlands. Besides inclusion from the general population, childhood expertise centres will contact their patients to pay attention to this study.
intervention type: Other
intervention name: Exposure to the Dutch measures due to the Covid-19 pandemic.
description: Several measures are taken in The Netherlands, due to the Covid-19 virus and pandemic. For example, closure of schools and sportclubs, and advices to stay at home as much as possible. During the pandemic, several measures also will be scaled down.
arm group label: Children with overweight or obesity
arm group label: Lean children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anita CE Vreugdenhil
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Anita CE Vreugdenhil, dr.
phone: 0031433875284
email: a.vreugdenhil@mumc.nl
last name: Lisanne Arayess, drs.
phone: 0031433875284
email: lisanne.arayess@mumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Obesity
mesh term: Overweight
mesh term: Pediatric Obesity