<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/NCT03242863</url>
  </required_header>
  <id_info>
    <org_study_id>ChildFood503</org_study_id>
    <secondary_id>R01DK082580</secondary_id>
    <nct_id>NCT03242863</nct_id>
  </id_info>
  <brief_title>Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children</brief_title>
  <official_title>Strategies to Moderate Energy Intake for the Prevention of Obesity in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</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>Penn State University</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>
      In this study, the investigators will vary the proportions of high- and low-energy-dense&#xD;
      foods served to preschool children at all meals and snacks during three 5-day periods. In the&#xD;
      three experimental conditions, the same foods will be served; only the amounts and&#xD;
      proportions of foods will be varied. In the Baseline condition, typical proportions of&#xD;
      age-appropriate foods will be served. In the Addition condition, the portion sizes of&#xD;
      low-energy-dense foods will be increased, and in the Substitution condition, the portions of&#xD;
      low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in&#xD;
      energy density. The primary aim is to determine the effect on children's energy intake of&#xD;
      varying the proportion of low- and high-energy-dense foods served, either by addition or&#xD;
      substitution, over 5 days. It is hypothesized that children will consume less energy when&#xD;
      they are served meals in which low-energy-dense foods are substituted for foods higher in&#xD;
      energy density over 5 days and that children will consume more energy when served meals to&#xD;
      which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily&#xD;
      energy intake in the three conditions will begin to converge across the 5-day period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">May 2, 2019</completion_date>
  <primary_completion_date type="Actual">May 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in Food and Beverage Intake by Energy</measure>
    <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily energy consumed of food and beverages, in kilocalories</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in Food and Beverage Intake by Weight</measure>
    <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily weight consumed of food and beverages, in grams</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in Food and Beverage Intake by Weight</measure>
    <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily weight consumed of vegetables and fruit, in grams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in Food and Beverage Intake by Energy Density</measure>
    <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily energy density consumed of food and beverages, in kilocalories/gram</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baseline proportions of high and low energy dense foods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Addition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increased portion of low energy dense foods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Substitution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food proportionality</intervention_name>
    <description>Proportions of high and low energy dense foods manipulated</description>
    <arm_group_label>Addition</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Substitution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attending one of the designated daycare centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food Allergies&#xD;
&#xD;
          -  Food restrictions&#xD;
&#xD;
          -  Health Issues that Preclude Participation&#xD;
&#xD;
          -  Not available for duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara J Rolls, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory for the Study of Human Ingestive Behavior</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>June 1, 2020</results_first_submitted>
  <results_first_submitted_qc>June 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2020</results_first_posted>
  <last_update_submitted>October 31, 2020</last_update_submitted>
  <last_update_submitted_qc>October 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Barbara J. Rolls</investigator_full_name>
    <investigator_title>Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03242863/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03242863/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Children were recruited from three childcare centers in central Pennsylvania between November 2017 and March 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Con First, Then Add, Then Sub</title>
          <description>Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Control, then Addition, then Substitution.</description>
        </group>
        <group group_id="P2">
          <title>Add First, Then Sub, Then Con</title>
          <description>Participants in the classrooms that received the three food proportionality interventions across the three periods in the order of Addition, then Substitution, then Control.</description>
        </group>
        <group group_id="P3">
          <title>Sub First, Then Con, Then Add</title>
          <description>Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Control, then Addition.</description>
        </group>
        <group group_id="P4">
          <title>Con First, Then Sub, Then Add</title>
          <description>Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Control, then Substitution, then Addition.</description>
        </group>
        <group group_id="P5">
          <title>Add First, Then Con, Then Sub</title>
          <description>Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Addition, then Control, then Substitution.</description>
        </group>
        <group group_id="P6">
          <title>Sub First, Then Add, Then Con</title>
          <description>Participants in the classroom that received the three food proportionality interventions across the three periods in the order of Substitution, then Addition, then Control.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Study Week 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="15"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Study Week 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Study Week 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Entire Study Population</title>
          <description>Enrolled participants who completed the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Differences in Food and Beverage Intake by Energy</title>
        <description>Differences in daily energy consumed of food and beverages, in kilocalories</description>
        <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Baseline proportions of high and low energy dense foods.</description>
          </group>
          <group group_id="O2">
            <title>Addition</title>
            <description>Increased portion of low energy dense foods.</description>
          </group>
          <group group_id="O3">
            <title>Substitution</title>
            <description>Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Energy</title>
          <description>Differences in daily energy consumed of food and beverages, in kilocalories</description>
          <units>kilocalories per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1059" spread="33"/>
                    <measurement group_id="O2" value="1118" spread="35"/>
                    <measurement group_id="O3" value="977" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Differences in Food and Beverage Intake by Weight</title>
        <description>Differences in daily weight consumed of food and beverages, in grams</description>
        <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Baseline proportions of high and low energy dense foods.</description>
          </group>
          <group group_id="O2">
            <title>Addition</title>
            <description>Increased portion of low energy dense foods.</description>
          </group>
          <group group_id="O3">
            <title>Substitution</title>
            <description>Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Weight</title>
          <description>Differences in daily weight consumed of food and beverages, in grams</description>
          <units>grams per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="868" spread="35"/>
                    <measurement group_id="O2" value="955" spread="36"/>
                    <measurement group_id="O3" value="908" spread="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0015</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Differences in Food and Beverage Intake by Weight</title>
        <description>Differences in daily weight consumed of vegetables and fruit, in grams</description>
        <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Baseline proportions of high and low energy dense foods.</description>
          </group>
          <group group_id="O2">
            <title>Addition</title>
            <description>Increased portion of low energy dense foods.</description>
          </group>
          <group group_id="O3">
            <title>Substitution</title>
            <description>Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Weight</title>
          <description>Differences in daily weight consumed of vegetables and fruit, in grams</description>
          <units>grams per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225" spread="15"/>
                    <measurement group_id="O2" value="296" spread="15"/>
                    <measurement group_id="O3" value="315" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Differences in Food and Beverage Intake by Energy Density</title>
        <description>Differences in daily energy density consumed of food and beverages, in kilocalories/gram</description>
        <time_frame>Day 1-5 in weeks 1, 2, and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Baseline proportions of high and low energy dense foods.</description>
          </group>
          <group group_id="O2">
            <title>Addition</title>
            <description>Increased portion of low energy dense foods.</description>
          </group>
          <group group_id="O3">
            <title>Substitution</title>
            <description>Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Energy Density</title>
          <description>Differences in daily energy density consumed of food and beverages, in kilocalories/gram</description>
          <units>kilocalories/gram per day</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.038"/>
                    <measurement group_id="O2" value="1.21" spread="0.039"/>
                    <measurement group_id="O3" value="1.14" spread="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>All participants during the Control condition</description>
        </group>
        <group group_id="E2">
          <title>Addition</title>
          <description>All participants during the Addition condition</description>
        </group>
        <group group_id="E3">
          <title>Substitution</title>
          <description>All participants during the Substitution condition</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Barbara J. Rolls</name_or_title>
      <organization>Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University</organization>
      <phone>814-863-8481</phone>
      <email>bjr4@psu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03242863
org study id: ChildFood503
secondary id: R01DK082580
nct id: NCT03242863
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators will vary the proportions of high- and low-energy-dense
      foods served to preschool children at all meals and snacks during three 5-day periods. In the
      three experimental conditions, the same foods will be served; only the amounts and
      proportions of foods will be varied. In the Baseline condition, typical proportions of
      age-appropriate foods will be served. In the Addition condition, the portion sizes of
      low-energy-dense foods will be increased, and in the Substitution condition, the portions of
      low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in
      energy density. The primary aim is to determine the effect on children's energy intake of
      varying the proportion of low- and high-energy-dense foods served, either by addition or
      substitution, over 5 days. It is hypothesized that children will consume less energy when
      they are served meals in which low-energy-dense foods are substituted for foods higher in
      energy density over 5 days and that children will consume more energy when served meals to
      which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily
      energy intake in the three conditions will begin to converge across the 5-day period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Differences in Food and Beverage Intake by Energy
time frame: Day 1-5 in weeks 1, 2, and 3
description: Differences in daily energy consumed of food and beverages, in kilocalories
measure: Differences in Food and Beverage Intake by Weight
time frame: Day 1-5 in weeks 1, 2, and 3
description: Differences in daily weight consumed of food and beverages, in grams
measure: Differences in Food and Beverage Intake by Weight
time frame: Day 1-5 in weeks 1, 2, and 3
description: Differences in daily weight consumed of vegetables and fruit, in grams
measure: Differences in Food and Beverage Intake by Energy Density
time frame: Day 1-5 in weeks 1, 2, and 3
description: Differences in daily energy density consumed of food and beverages, in kilocalories/gram
arm group label: Control
arm group type: Experimental
description: Baseline proportions of high and low energy dense foods.
arm group label: Addition
arm group type: Experimental
description: Increased portion of low energy dense foods.
arm group label: Substitution
arm group type: Experimental
description: Increased portion of low energy dense foods substituted for equal portion of foods higher in energy density.
intervention type: Other
intervention name: Food proportionality
description: Proportions of high and low energy dense foods manipulated
arm group label: Addition
arm group label: Control
arm group label: Substitution
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
last name: Barbara J Rolls, PhD
role: Principal Investigator
affiliation: Penn State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Barbara J. Rolls
investigator title: Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 