xml: <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/NCT06030687</url>
    </required_header>
    <id_info>
      <org_study_id>PBRC 2023-045 A</org_study_id>
      <nct_id>NCT06030687</nct_id>
    </id_info>
    <brief_title>FoodImage 3 Free-Living</brief_title>
    <acronym>FI3FL</acronym>
    <official_title>Multiscale RECIPES (Resilient, Equitable, and Circular Innovations With Partnership and Education Synergies) for Sustainable Food Systems (FoodImage 3; FI3) Free-Living</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pennington Biomedical Research Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Corby K. Martin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Pennington Biomedical Research Center</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>
        Participants will be asked to use the app to capture data on food purchases, food waste that&#xD;
        occurs during food preparation, food waste that is present after eating, and food waste from&#xD;
        cabinet and refrigerator/freezer clean-outs. During collection of much of the food waste&#xD;
        data, participants will record in the app if food waste will be disposed of via composting,&#xD;
        disposal, fed to pets, or garbage/landfill. They will also indicate if the food was spoiled,&#xD;
        past the expiration date, etc. This will occur for 4-8 days. Participants should perform the&#xD;
        prep and eat occasions 4-8 days. The shopping and toss occasions should be completed for at&#xD;
        least 7 days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Total weight of household food waste</measure>
      <time_frame>daily during baseline collection</time_frame>
      <description>weight (g)</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Waste Management</condition>
    <condition>Food Supply</condition>
    <condition>Climate</condition>
    <condition>Nutrition Sciences</condition>
    <arm_group>
      <arm_group_label>Free-Living</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ad libitum data collection</intervention_name>
      <description>Food purchase, prep, eat and toss data</description>
      <arm_group_label>Free-Living</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or Female, age 18-65 years&#xD;
  &#xD;
            -  Willing to be recontacted&#xD;
  &#xD;
            -  Conducts some of the food shopping, food purchasing, and/or food preparation for their&#xD;
               household.&#xD;
  &#xD;
            -  Internet and/or Wi-Fi availability to complete surveys and send images.&#xD;
  &#xD;
            -  Ownership of an iPhone 9S or later, operable Apple ID, password, and email address&#xD;
               that they are willing and able to use to collect data during the study. Subject&#xD;
               acknowledges data usage and associated charges are a result of study.&#xD;
  &#xD;
            -  Willing to complete all study procedures and adhere to study visit timelines -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal or unable to use an iPhone for study related purposes.&#xD;
  &#xD;
            -  Not willing to adhere to study procedures and study visit timelines.&#xD;
  &#xD;
            -  PBRC employee&#xD;
  &#xD;
            -  Any condition or circumstance that in the judgement of the PI could interfere with&#xD;
               study participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John W Apolzan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pennington Biomedical Research Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>John W Apolzan, PhD</last_name>
      <phone>2257632827</phone>
      <email>john.apolzan@pbrc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rob Leonard</last_name>
      <phone>2257630948</phone>
      <email>doctors@pbrc.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
      <investigator_full_name>John Apolzan</investigator_full_name>
      <investigator_title>Associate Professor-Research</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Data may be requested. The PI will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution may be requested.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030687
  org study id: PBRC 2023-045 A
  nct id: NCT06030687
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Participants will be asked to use the app to capture data on food purchases, food waste that
        occurs during food preparation, food waste that is present after eating, and food waste from
        cabinet and refrigerator/freezer clean-outs. During collection of much of the food waste
        data, participants will record in the app if food waste will be disposed of via composting,
        disposal, fed to pets, or garbage/landfill. They will also indicate if the food was spoiled,
        past the expiration date, etc. This will occur for 4-8 days. Participants should perform the
        prep and eat occasions 4-8 days. The shopping and toss occasions should be completed for at
        least 7 days.
  observational model: Case-Only
  time perspective: Prospective
  measure: Total weight of household food waste
  time frame: daily during baseline collection
  description: weight (g)
  arm group label: Free-Living
  intervention type: Other
  intervention name: Ad libitum data collection
  description: Food purchase, prep, eat and toss data
  arm group label: Free-Living
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: John W Apolzan, PhD
  role: Principal Investigator
  affiliation: Pennington Biomedical Research Center
  last name: John W Apolzan, PhD
  phone: 2257632827
  email: john.apolzan@pbrc.edu
  last name: Rob Leonard
  phone: 2257630948
  email: doctors@pbrc.edu
  responsible party type: Principal Investigator
  investigator affiliation: Pennington Biomedical Research Center
  investigator full name: John Apolzan
  investigator title: Associate Professor-Research
  sharing ipd: Undecided
  ipd description: Data may be requested. The PI will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution may be requested.