<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/NCT01719445</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 10040</org_study_id>
    <secondary_id>R01DK089051</secondary_id>
    <nct_id>NCT01719445</nct_id>
  </id_info>
  <brief_title>The Food Phone Project</brief_title>
  <acronym>FPP</acronym>
  <official_title>Remote Food Photography for the Real-time Measurement of Children's Food Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Primary Aim of the project is to modify the RFPM for adolescents and to address the&#xD;
      concerns identified by the reviewers of the first grant application. We will then test the&#xD;
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Primary Aim of the project is to modify the RFPM for adolescents and to address the&#xD;
      concerns identified by the reviewers of the first grant application. We will then test the&#xD;
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records. Our&#xD;
      experience and the literature indicate that the RFPM is acceptable and feasible in school&#xD;
      settings. Following modification of the RFPM and pilot testing with 4 adolescents, we will&#xD;
      test the reliability and validity of both the RFPM and food records when used by 60&#xD;
      adolescents (12 to 18 years of age). During one week, participants will use the RFPM and&#xD;
      during another week they will use food records (the order will be balanced across&#xD;
      participants). The accuracy of each method will be examined by comparing energy and nutrient&#xD;
      intake (collectively referred to as food intake or FI) to three gold standards: 1) doubly&#xD;
      labeled water or DLW (energy intake only, or EIDLW), 2) a laboratory-based test meal&#xD;
      (FILaboratory), and 3) food intake during lunch in a school cafeteria (FISchool).&#xD;
      User-satisfaction and participant burden will also be compared between methods, and a&#xD;
      cost-effectiveness analysis will determine if and under what conditions one method is more&#xD;
      cost-effective than the other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Doubly Labeled Water (DLW)</measure>
    <time_frame>2 weeks</time_frame>
    <description>Doubly labeled water will be used to measure total daily energy expenditure (TEE) and Energy Intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Remote Food Photography Method (RFPM)</measure>
    <time_frame>7 days</time_frame>
    <description>In brief, adolescents will be trained to use a Smartphone and the Food Image App to capture images of their food selection and plate waste and to send the data packets to Food Photo II via the wireless network.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pen-and-paper Food Records</measure>
    <time_frame>7 days</time_frame>
    <description>Participants will be instructed how to keep a food record and estimate portion size during a session at the Center. Participants will also receive a packet containing the food protocol outline, food record form, guide to portion sizes, guidelines for description of foods, and tips for recording food intake. Participants will be instructed to record everything they eat or drink, recording the food item, portion size, time of consumption, and meal designation.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Comparison of Energy Intake Methods</condition>
  <arm_group>
    <arm_group_label>RFPM/Paper and Pen Method</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine collection as part DLW procedure.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        50 adolescents will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  boy or girl of any race&#xD;
&#xD;
          -  age 12 to 18 years, inclusive&#xD;
&#xD;
          -  willing to use the RFPM for one week and pen-and-paper food records for one week&#xD;
&#xD;
          -  willing to complete one laboratory-based food test during week 3&#xD;
&#xD;
          -  willing to use the RFPM and food records during the laboratory-based test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -weight unstable (&gt;1.1 pounds weight change in one week based on regressed daily body&#xD;
        weights).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corby K 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>January 2016</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Energy Intake</keyword>
  <!-- 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/NCT01719445
org study id: PBRC 10040
secondary id: R01DK089051
nct id: NCT01719445
lead sponsor: 
collaborator: 
has dmc: Yes
The Primary Aim of the project is to modify the RFPM for adolescents and to address the
      concerns identified by the reviewers of the first grant application. We will then test the
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.
The Primary Aim of the project is to modify the RFPM for adolescents and to address the
      concerns identified by the reviewers of the first grant application. We will then test the
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records. Our
      experience and the literature indicate that the RFPM is acceptable and feasible in school
      settings. Following modification of the RFPM and pilot testing with 4 adolescents, we will
      test the reliability and validity of both the RFPM and food records when used by 60
      adolescents (12 to 18 years of age). During one week, participants will use the RFPM and
      during another week they will use food records (the order will be balanced across
      participants). The accuracy of each method will be examined by comparing energy and nutrient
      intake (collectively referred to as food intake or FI) to three gold standards: 1) doubly
      labeled water or DLW (energy intake only, or EIDLW), 2) a laboratory-based test meal
      (FILaboratory), and 3) food intake during lunch in a school cafeteria (FISchool).
      User-satisfaction and participant burden will also be compared between methods, and a
      cost-effectiveness analysis will determine if and under what conditions one method is more
      cost-effective than the other.
observational model: Cohort
time perspective: Prospective
measure: Doubly Labeled Water (DLW)
time frame: 2 weeks
description: Doubly labeled water will be used to measure total daily energy expenditure (TEE) and Energy Intake.
measure: The Remote Food Photography Method (RFPM)
time frame: 7 days
description: In brief, adolescents will be trained to use a Smartphone and the Food Image App to capture images of their food selection and plate waste and to send the data packets to Food Photo II via the wireless network.
measure: Pen-and-paper Food Records
time frame: 7 days
description: Participants will be instructed how to keep a food record and estimate portion size during a session at the Center. Participants will also receive a packet containing the food protocol outline, food record form, guide to portion sizes, guidelines for description of foods, and tips for recording food intake. Participants will be instructed to record everything they eat or drink, recording the food item, portion size, time of consumption, and meal designation.
arm group label: RFPM/Paper and Pen Method
Urine collection as part DLW procedure.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Corby K 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: Principal Investigator