<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/NCT01725347</url>
  </required_header>
  <id_info>
    <org_study_id>H-29112</org_study_id>
    <secondary_id>R01CA142919-01A1</secondary_id>
    <nct_id>NCT01725347</nct_id>
  </id_info>
  <brief_title>Validation of a Digital Diet Method for Use With Preschoolers</brief_title>
  <official_title>Validation of a Digital Diet Method for Use With Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Validation of a Digital Diet Method project is very innovative because it links three&#xD;
      methods to address the gap in measuring food intake of HS preschool children. Data collection&#xD;
      is based on EMA theory; participant burden is low, and the Food Image App decreases&#xD;
      participant and staff burden even further. Data management and analysis are semi-automated&#xD;
      and relies on advanced computer algorithms. A strength of this approach is its&#xD;
      semi-automation, which allows us to leverage the strengths of human operators and computer&#xD;
      automation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the proposed research is to modify the Remote Food Photography Method (RFPM) for&#xD;
      use with preschoolers. Primary caregivers (the majority will be mothers) and HS assistants&#xD;
      will use a Smartphone to capture 24-hour images of HS children's food selection and plate&#xD;
      waste. The RFPM, Ecological Momentary Assessment (EMA). and the Food Photography Application©&#xD;
      will be used to estimate the energy and nutrient intake of preschoolers. The accuracy of the&#xD;
      RFPM will be examined by determining the energy and nutrient intake (collectively referred to&#xD;
      as food intake [FI]) to established methods: 1) actual gram (g) weights of laboratory-based&#xD;
      test meals and 2) doubly labeled water (DLW) in a natural environment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy intake calculated using weight measures (actual weighing of all food/beverages consumed).</measure>
    <time_frame>12 months</time_frame>
    <description>The Bland-Altman method was used to measure the agreement between digital photography estimated weight and actual weight. This method uses a two step process that evaluates the accuracy (validity) of a &quot;new&quot; measurement technique compared to and existing &quot;gold standard&quot;, which was the actual weights of foods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy expenditure using the Doubly Labeled Water method (DLW).</measure>
    <time_frame>12 months</time_frame>
    <description>The Same statistical analysis methods used for the Primary Outcome Measure will be applied. Additionally, the Bland-Altman technique will be used to assess the degree of agreement between the two methods.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>Feeding Behaviors</condition>
  <arm_group>
    <arm_group_label>African American Girls</arm_group_label>
    <description>-25% of sample is African American Girls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African American Boys</arm_group_label>
    <description>-25% of sample is African American Boys</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hispanic American Girls</arm_group_label>
    <description>-25% of sample is Hispanic American Girls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hispanic American Boys</arm_group_label>
    <description>-25% of sample is Hispanic American Boys</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine samples are to be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        With an anticipated attrition rate of 15%, 62 children will be recruited, resulting in a&#xD;
        sample size of 54 after attrition (14 HA boys; 14 HA girls; 13 AA boys; 13 AA girls).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3-5 years old&#xD;
&#xD;
          -  Attends Head Start&#xD;
&#xD;
          -  African-American&#xD;
&#xD;
          -  Hispanic American&#xD;
&#xD;
          -  Can physically complete the tasks required in the proposed research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 3 years old&#xD;
&#xD;
          -  Older than 5 years old&#xD;
&#xD;
          -  Does not attend Head Start&#xD;
&#xD;
          -  Race/Ethnicity other than African-American or Hispanic-American&#xD;
&#xD;
          -  Cannot physically complete the tasks required in the proposed research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa A Nicklas, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA/ARS Children's Nutrition Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Nicklas TA, O'Neil CE, Stuff J, Goodell LS, Liu Y, Martin CK. Validity and feasibility of a digital diet estimation method for use with preschool children: a pilot study. J Nutr Educ Behav. 2012 Nov-Dec;44(6):618-23. doi: 10.1016/j.jneb.2011.12.001. Epub 2012 Jun 23.</citation>
    <PMID>22727939</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Theresa A Nicklas</investigator_full_name>
    <investigator_title>Professor of Pediatric Nutrition</investigator_title>
  </responsible_party>
  <keyword>nutrition assessment</keyword>
  <keyword>children</keyword>
  <keyword>preschool</keyword>
  <keyword>eating behavior</keyword>
  <keyword>Head Start</keyword>
  <keyword>digital technology</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/NCT01725347
org study id: H-29112
secondary id: R01CA142919-01A1
nct id: NCT01725347
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The Validation of a Digital Diet Method project is very innovative because it links three
      methods to address the gap in measuring food intake of HS preschool children. Data collection
      is based on EMA theory; participant burden is low, and the Food Image App decreases
      participant and staff burden even further. Data management and analysis are semi-automated
      and relies on advanced computer algorithms. A strength of this approach is its
      semi-automation, which allows us to leverage the strengths of human operators and computer
      automation.
The goal of the proposed research is to modify the Remote Food Photography Method (RFPM) for
      use with preschoolers. Primary caregivers (the majority will be mothers) and HS assistants
      will use a Smartphone to capture 24-hour images of HS children's food selection and plate
      waste. The RFPM, Ecological Momentary Assessment (EMA). and the Food Photography Application©
      will be used to estimate the energy and nutrient intake of preschoolers. The accuracy of the
      RFPM will be examined by determining the energy and nutrient intake (collectively referred to
      as food intake [FI]) to established methods: 1) actual gram (g) weights of laboratory-based
      test meals and 2) doubly labeled water (DLW) in a natural environment.
observational model: Other
time perspective: Cross-Sectional
measure: This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy intake calculated using weight measures (actual weighing of all food/beverages consumed).
time frame: 12 months
description: The Bland-Altman method was used to measure the agreement between digital photography estimated weight and actual weight. This method uses a two step process that evaluates the accuracy (validity) of a "new" measurement technique compared to and existing "gold standard", which was the actual weights of foods.
measure: This experiment will compare energy intake (EI) calculated using the test method (Remote Food Photography Method or RFPM) against energy expenditure using the Doubly Labeled Water method (DLW).
time frame: 12 months
description: The Same statistical analysis methods used for the Primary Outcome Measure will be applied. Additionally, the Bland-Altman technique will be used to assess the degree of agreement between the two methods.
arm group label: African American Girls
description: -25% of sample is African American Girls
arm group label: African American Boys
description: -25% of sample is African American Boys
arm group label: Hispanic American Girls
description: -25% of sample is Hispanic American Girls
arm group label: Hispanic American Boys
description: -25% of sample is Hispanic American Boys
Urine samples are to be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Theresa A Nicklas, DrPH
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
citation: Nicklas TA, O'Neil CE, Stuff J, Goodell LS, Liu Y, Martin CK. Validity and feasibility of a digital diet estimation method for use with preschool children: a pilot study. J Nutr Educ Behav. 2012 Nov-Dec;44(6):618-23. doi: 10.1016/j.jneb.2011.12.001. Epub 2012 Jun 23.
PMID: 22727939
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Theresa A Nicklas
investigator title: Professor of Pediatric Nutrition