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/NCT05972824</url>
    </required_header>
    <id_info>
      <org_study_id>PBRC 2023-007 C</org_study_id>
      <nct_id>NCT05972824</nct_id>
    </id_info>
    <brief_title>Food Survey, Curbside, Remote APPS - Laboratory</brief_title>
    <acronym>FoodSCRAPPsLab</acronym>
    <official_title>An Innovative, Accessible, and Flexible Approach for Household Food Waste Measurement - Laboratory</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pennington Biomedical Research Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Prachi Singh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Robbie A. Beyl</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Frank L. Greenway</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 perform the FoodImage app in the lab. A survey will be provided after the&#xD;
        study visit. Also the bag of combined waste will be given to a hired contractor who will sort&#xD;
        and weigh the waste, thus creating a second estimate of waste and its key components using&#xD;
        standard industry practices (i.e. curbside).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        he Lab Study will be conducted at PBRC and will include participants (N=25) from a wide array&#xD;
        of social and economic groups will be recruited and trained on the use of the FoodImage app.&#xD;
        Participants use the app to measure food waste (including foods with inedible parts) created&#xD;
        during a simulated meal preparation setting, a simulated meal consumption setting with plate&#xD;
        waste, and a simulated cabinet and refrigerator clean-out of spoiled and out-of-date foods,&#xD;
        where the number of items and the amounts of waste for each task is randomly assigned across&#xD;
        participants and blinded from the research staff evaluating images and coding data. These&#xD;
        participants will denote the normal discard destination (I.e., garbage, sink/disposal, feed&#xD;
        to animal, compost) for each item as if the waste had occurred in their own home. The&#xD;
        resulting photos will be processed, and data created using the methods detailed in our&#xD;
        previously published work.&#xD;
  &#xD;
        All foods to be measured by the participant during each task will be weighed by staff. Then,&#xD;
        the items that participants note as suitable for discard via sink, garbage disposal, fed to&#xD;
        pet or compost in their own homes are set aside and appropriately documented with the&#xD;
        remaining items thrown in a standard trash bag that also contains waste amounts and types&#xD;
        that mirror US solid municipal waste figures (about 80% of waste is non-food). The bag of&#xD;
        combined waste will be given to a hired contractor who will sort and weigh the waste, thus&#xD;
        creating a second estimate of waste and its key components using standard industry practices.&#xD;
  &#xD;
        Three to five days after completing the lab tasks, participants will receive the&#xD;
        retrospective online survey and complete it for the tasks they completed during the lab&#xD;
        study. Estimates of food waste (edible portions only) will be constructed from the survey&#xD;
        results using methods previously described.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Food Waste Weight</measure>
      <time_frame>Study Visit ~ 1 day</time_frame>
      <description>Weight (g)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Food Waste Energy</measure>
      <time_frame>Study Visit ~1 day</time_frame>
      <description>Energy (kcal)</description>
    </secondary_outcome>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Industrial Waste</condition>
    <condition>Climate</condition>
    <condition>Climate Change</condition>
    <condition>Waste Management</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy participants from the greater Baton Rouge, LA area.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female, age 18-62 years&#xD;
  &#xD;
            -  Has an iPhone 9s or later, operable Apple ID, password, and email address that they&#xD;
               are willing and able to use to collect data during the study. Subject acknowledges&#xD;
               data usage and associated charges are a result of study participation. Willing to&#xD;
               complete all study procedures and adhere to study 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;
            -  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>62 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>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication after a DTA with the institution. A research question should be included.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </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/NCT05972824
  org study id: PBRC 2023-007 C
  nct id: NCT05972824
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Participants will perform the FoodImage app in the lab. A survey will be provided after the
        study visit. Also the bag of combined waste will be given to a hired contractor who will sort
        and weigh the waste, thus creating a second estimate of waste and its key components using
        standard industry practices (i.e. curbside).
  he Lab Study will be conducted at PBRC and will include participants (N=25) from a wide array
        of social and economic groups will be recruited and trained on the use of the FoodImage app.
        Participants use the app to measure food waste (including foods with inedible parts) created
        during a simulated meal preparation setting, a simulated meal consumption setting with plate
        waste, and a simulated cabinet and refrigerator clean-out of spoiled and out-of-date foods,
        where the number of items and the amounts of waste for each task is randomly assigned across
        participants and blinded from the research staff evaluating images and coding data. These
        participants will denote the normal discard destination (I.e., garbage, sink/disposal, feed
        to animal, compost) for each item as if the waste had occurred in their own home. The
        resulting photos will be processed, and data created using the methods detailed in our
        previously published work.
  
        All foods to be measured by the participant during each task will be weighed by staff. Then,
        the items that participants note as suitable for discard via sink, garbage disposal, fed to
        pet or compost in their own homes are set aside and appropriately documented with the
        remaining items thrown in a standard trash bag that also contains waste amounts and types
        that mirror US solid municipal waste figures (about 80% of waste is non-food). The bag of
        combined waste will be given to a hired contractor who will sort and weigh the waste, thus
        creating a second estimate of waste and its key components using standard industry practices.
  
        Three to five days after completing the lab tasks, participants will receive the
        retrospective online survey and complete it for the tasks they completed during the lab
        study. Estimates of food waste (edible portions only) will be constructed from the survey
        results using methods previously described.
  observational model: Case-Only
  time perspective: Other
  measure: Food Waste Weight
  time frame: Study Visit ~ 1 day
  description: Weight (g)
  measure: Food Waste Energy
  time frame: Study Visit ~1 day
  description: Energy (kcal)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 62 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: Yes
  ipd description: All IPD that underlie results in a publication after a DTA with the institution. A research question should be included.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)