<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/NCT04407533</url>
  </required_header>
  <id_info>
    <org_study_id>20-04-064</org_study_id>
    <nct_id>NCT04407533</nct_id>
  </id_info>
  <brief_title>Dietary Intake and Eating Habits During the COVID-19 Pandemic</brief_title>
  <acronym>COVIDiet</acronym>
  <official_title>Dietary Intake and Eating Habits During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University</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 COVID-19 pandemic affects eating habits, diet quality and physical activity differently&#xD;
      among individuals; it is unclear how these behaviours will evolve as the pandemic continues.&#xD;
      In this observational study, dietary intake will be frequently collected using an artificial&#xD;
      intelligence (AI)-enhanced mobile application combined with real-time analysis, and lifestyle&#xD;
      behaviours from online questionnaires, to provide timely, relevant data for public health&#xD;
      decision making.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A thousand nine hundred and twenty adult men and women aged 18 years and older, living in the&#xD;
      community and owning a smartphone or tablet, will be recruited all over Canada. Rapid&#xD;
      recruitment will be achieved using social media and professional networks. All data will be&#xD;
      collected online to allow a broad reach even in remote regions. Self-reported eating habits,&#xD;
      physical activity, sleep, alcohol consumption, anxiety and depression data will be collected&#xD;
      using validated questionnaires on an online survey platform, and dietary intake data using&#xD;
      the mobile application Keenoa. With the application, participants take pictures of their&#xD;
      meals, which are analyzed and accessible to researchers in real-time, providing comprehensive&#xD;
      data on nutrient and food intake, and hence patterns and diet quality. Diet will be tracked&#xD;
      for a full week at study entrance and repeated 6 times during a year, and once one year&#xD;
      later, along with follow-up questionnaires on lifestyle behaviours.&#xD;
&#xD;
      The main study objectives are 1) to evaluate how eating habits, diet quality and related&#xD;
      lifestyle behaviours of Canadian adults are impacted by confinement phases of the pandemic&#xD;
      over one year; and 2) determine the association between eating behaviours and diet quality&#xD;
      with contextual socio-demographic, education, emotional and health factors, and identify&#xD;
      emerging explanatory factors as clusters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>Two years</time_frame>
    <description>Energy, macronutrients, micronutrients, and food intake assessed with the Keenoa mobile application</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet quality</measure>
    <time_frame>Two years</time_frame>
    <description>Calculated from food group intake as per the Canadian Healthy Eating Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating habits</measure>
    <time_frame>Two years</time_frame>
    <description>Eating behaviors, food access and cooking skills collected from online questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">2020</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet tracking and survey</intervention_name>
    <description>Mobile AI-based food diary application and online questionnaires</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 1,920 adult men and women will be recruited from several regions of Canada,&#xD;
        and stratified by age (18-45 y, 45-65 y, 65 y+).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years and over, living in Canada&#xD;
&#xD;
          -  Owning a smartphone and having access to internet&#xD;
&#xD;
          -  Able to read and understand English or French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active and uncontrolled acute disease that interferes with usual food intake&#xD;
&#xD;
          -  Being hospitalized&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>McGill University - School of Human Nutrition</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H9X 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Stéphanie Chevalier</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>nutrition</keyword>
  <keyword>dietary intake</keyword>
  <keyword>eating habits</keyword>
  <keyword>lifestyle behaviours</keyword>
  <keyword>physical activity</keyword>
  <keyword>sleep</keyword>
  <keyword>artificial intelligence</keyword>
  <keyword>mobile application</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>
  </patient_data>
  <!-- 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/NCT04407533
org study id: 20-04-064
nct id: NCT04407533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic affects eating habits, diet quality and physical activity differently
      among individuals; it is unclear how these behaviours will evolve as the pandemic continues.
      In this observational study, dietary intake will be frequently collected using an artificial
      intelligence (AI)-enhanced mobile application combined with real-time analysis, and lifestyle
      behaviours from online questionnaires, to provide timely, relevant data for public health
      decision making.
A thousand nine hundred and twenty adult men and women aged 18 years and older, living in the
      community and owning a smartphone or tablet, will be recruited all over Canada. Rapid
      recruitment will be achieved using social media and professional networks. All data will be
      collected online to allow a broad reach even in remote regions. Self-reported eating habits,
      physical activity, sleep, alcohol consumption, anxiety and depression data will be collected
      using validated questionnaires on an online survey platform, and dietary intake data using
      the mobile application Keenoa. With the application, participants take pictures of their
      meals, which are analyzed and accessible to researchers in real-time, providing comprehensive
      data on nutrient and food intake, and hence patterns and diet quality. Diet will be tracked
      for a full week at study entrance and repeated 6 times during a year, and once one year
      later, along with follow-up questionnaires on lifestyle behaviours.

      The main study objectives are 1) to evaluate how eating habits, diet quality and related
      lifestyle behaviours of Canadian adults are impacted by confinement phases of the pandemic
      over one year; and 2) determine the association between eating behaviours and diet quality
      with contextual socio-demographic, education, emotional and health factors, and identify
      emerging explanatory factors as clusters.
observational model: Ecologic or Community
time perspective: Prospective
measure: Dietary intake
time frame: Two years
description: Energy, macronutrients, micronutrients, and food intake assessed with the Keenoa mobile application
measure: Diet quality
time frame: Two years
description: Calculated from food group intake as per the Canadian Healthy Eating Index
measure: Eating habits
time frame: Two years
description: Eating behaviors, food access and cooking skills collected from online questionnaire
intervention type: Other
intervention name: Diet tracking and survey
description: Mobile AI-based food diary application and online questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Stéphanie Chevalier
investigator title: Associate Professor
mesh term: COVID-19
sharing ipd: Undecided