<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/NCT04494971</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC_2019-013</org_study_id>
    <nct_id>NCT04494971</nct_id>
  </id_info>
  <brief_title>The PortionSize Smartphone App Pilot (PS Pilot)</brief_title>
  <acronym>PS Pilot</acronym>
  <official_title>Pilot Validation of an App to Estimate and Manage Portion Size: The PortionSize Smartphone App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      The objective is to examine the preliminary validity, reliability and perceived participant&#xD;
      satisfaction of the PortionSize app.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overweight and obesity are a burgeoning public health concern, yet only a small minority of&#xD;
      smartphone apps that claim to facilitate healthy eating and weight loss incorporate&#xD;
      evidence-based principles. Such innovations are important as humans fundamentally cannot&#xD;
      accurately estimate portion size. Indeed, portion size estimation errors account for ~50% of&#xD;
      the error in self-reported food intake, and data from our laboratory has demonstrated that&#xD;
      extensive training results in only modest improvements in portion size estimation accuracy&#xD;
      and that portion size estimates remain inaccurate. Our long-term goal is to create simple and&#xD;
      accessible interventions that assist individuals with weight control. In particular, we aim&#xD;
      to provide easy-to-use phone apps that allow participants to monitor the portion sizes of the&#xD;
      foods they consume. These apps guide participants on appropriate portion sizes and provide&#xD;
      recommendations of food groups that should be consumed. To that end, we have developed the&#xD;
      PortionSize app. We propose to improve the accuracy of portion size measurement, as it is&#xD;
      poorly determined by self-report measures. This will occur via the development of the&#xD;
      PortionSize smartphone app and this pilot study will test the usability as well as&#xD;
      preliminary validity and reliability of the app functionality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">November 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</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>Validity of portion size at estimating energy intake</measure>
    <time_frame>August - December 2020</time_frame>
    <description>Compared measurements from PortionSize to weighed values in the lab.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of portion size at estimating energy intake</measure>
    <time_frame>August - December 2020</time_frame>
    <description>Quantify the reliability of app measurements over time in free-living conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>User satisfaction</measure>
    <time_frame>August - December 2020</time_frame>
    <description>Participant ratings of the PortionSize App</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Dietary Habits</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy participants ages 18 to 65 in the Baton Rouge, LA area.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 18.5-45 kg/m2 based upon self-reported height and weight&#xD;
&#xD;
          -  Have an iPhone and an operable Apple ID, password, and email address and is willing to&#xD;
             use these to collect data during the study, acknowledging that data usage, and&#xD;
             associated charges, are a result of study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For females, pregnancy or breast feeding&#xD;
&#xD;
          -  Currently diagnosed with an eating disorder&#xD;
&#xD;
          -  Disease that severely affects metabolism, including diabetes, hypercholesterolemia, or&#xD;
             dyslipidemia&#xD;
&#xD;
          -  Has gained or lost more than 10 lbs in the last 3 months&#xD;
&#xD;
          -  PBRC faculty/staff member&#xD;
&#xD;
          -  Has suffered serious mental illness that has resulted in serious functional impairment&#xD;
             and has substantially interfered with one's life activities within the last 5 years&#xD;
&#xD;
          -  Any other medical, psychiatric, or behavioral factors in the judgment of the Principle&#xD;
             Investigator that may interfere with study participation or the ability to follow the&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>John Apolzan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Dorling, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corby Martin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Corby K. Martin</investigator_full_name>
    <investigator_title>PBRC Professor, Director - Ingestive Behavior Laboratory</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04494971
org study id: PBRC_2019-013
nct id: NCT04494971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective is to examine the preliminary validity, reliability and perceived participant
      satisfaction of the PortionSize app.
Overweight and obesity are a burgeoning public health concern, yet only a small minority of
      smartphone apps that claim to facilitate healthy eating and weight loss incorporate
      evidence-based principles. Such innovations are important as humans fundamentally cannot
      accurately estimate portion size. Indeed, portion size estimation errors account for ~50% of
      the error in self-reported food intake, and data from our laboratory has demonstrated that
      extensive training results in only modest improvements in portion size estimation accuracy
      and that portion size estimates remain inaccurate. Our long-term goal is to create simple and
      accessible interventions that assist individuals with weight control. In particular, we aim
      to provide easy-to-use phone apps that allow participants to monitor the portion sizes of the
      foods they consume. These apps guide participants on appropriate portion sizes and provide
      recommendations of food groups that should be consumed. To that end, we have developed the
      PortionSize app. We propose to improve the accuracy of portion size measurement, as it is
      poorly determined by self-report measures. This will occur via the development of the
      PortionSize smartphone app and this pilot study will test the usability as well as
      preliminary validity and reliability of the app functionality.
observational model: Case-Only
time perspective: Prospective
measure: Validity of portion size at estimating energy intake
time frame: August - December 2020
description: Compared measurements from PortionSize to weighed values in the lab.
measure: Reliability of portion size at estimating energy intake
time frame: August - December 2020
description: Quantify the reliability of app measurements over time in free-living conditions.
measure: User satisfaction
time frame: August - December 2020
description: Participant ratings of the PortionSize App
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: John Apolzan, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
last name: James Dorling, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
last name: Corby Martin, PhD
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Corby K. Martin
investigator title: PBRC Professor, Director - Ingestive Behavior Laboratory
sharing ipd: No