<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/NCT03010501</url>
  </required_header>
  <id_info>
    <org_study_id>ChildFood502</org_study_id>
    <secondary_id>R01DK082580</secondary_id>
    <nct_id>NCT03010501</nct_id>
  </id_info>
  <brief_title>Effect of Energy Density Over 5 Days in Preschool Children</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will vary the energy density of foods served during three&#xD;
      5-day periods. There will be a baseline condition, and then a condition where the energy&#xD;
      density of food is lower and a condition where the energy density of food is higher. The&#xD;
      primary aim is to determine the effect of varying the energy density of foods served over 5&#xD;
      days on energy intake in preschool children. It is hypothesized that mean daily energy intake&#xD;
      will be greater when children are served higher energy dense foods over 5 days than when&#xD;
      served lower energy dense foods over the same period. Additionally, it is hypothesized that&#xD;
      daily energy intake in the conditions with higher and lower energy densities will begin to&#xD;
      converge across the 5-day period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Days 1-5 in Weeks 1, 2, and 3</time_frame>
    <description>Differences in daily intake of food and beverages by energy, in kcal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in Food and Beverage Intake by Weight</measure>
    <time_frame>Days 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily intake of food and beverages by weight, in grams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in Food and Beverage Intake by Energy Density</measure>
    <time_frame>Days 1-5 in weeks 1, 2, and 3</time_frame>
    <description>Differences in daily intake of food and beverages by energy density, in kcal/g</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>100% Food Energy Density</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baseline Food Energy Density</description>
  </arm_group>
  <arm_group>
    <arm_group_label>80% Food Energy Density</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lower Food Energy Density</description>
  </arm_group>
  <arm_group>
    <arm_group_label>120% Food Energy Density</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Higher Food Energy Density</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food Energy Density</intervention_name>
    <description>Food Energy density manipulated</description>
    <arm_group_label>100% Food Energy Density</arm_group_label>
    <arm_group_label>120% Food Energy Density</arm_group_label>
    <arm_group_label>80% Food Energy Density</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</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>July 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>May 17, 2019</results_first_submitted>
  <results_first_submitted_qc>July 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2019</results_first_posted>
  <last_update_submitted>July 10, 2019</last_update_submitted>
  <last_update_submitted_qc>July 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2019</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>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>July 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03010501/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Children aged 3 to 5 years old were recruited from classrooms at three childcare centers in State College, PA by distributing letters to parents between September 2016 and September 2017.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>80% Food Energy Density First, Then 100%, Then 120%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 100%, then 120%.</description>
        </group>
        <group group_id="P2">
          <title>100% Food Energy Density First, Then 120%, Then 80%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 120%, then 80%.</description>
        </group>
        <group group_id="P3">
          <title>120% Food Energy Density First, Then 80%, Then 100%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 80%, then 100%.</description>
        </group>
        <group group_id="P4">
          <title>80% Food Energy Density First, Then 120%, Then 100%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 80%, then 120%, then 100%.</description>
        </group>
        <group group_id="P5">
          <title>100% Food Energy Density, Then 80%, Then 120%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 100%, then 80%, then 120%.</description>
        </group>
        <group group_id="P6">
          <title>120% Food Energy Density, Then 100%, Then 80%</title>
          <description>Participants in the classroom that received the three food energy density interventions across the three periods in the order of 120%, then 100%, then 80%.</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="9"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <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="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <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="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </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="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="11"/>
              </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="1"/>
                <participants group_id="P5" count="0"/>
                <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="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The data of one participant was excluded from analysis due to absence from meals on three or more days of each 5-day study period.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Enrolled participants who completed the trial and whose data was not excluded from analysis</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
          </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="4.3" spread="0.7"/>
                  </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="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="4"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="49"/>
                  </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 intake of food and beverages by energy, in kcal</description>
        <time_frame>Days 1-5 in Weeks 1, 2, and 3</time_frame>
        <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
        <group_list>
          <group group_id="O1">
            <title>100% Food Energy Density</title>
            <description>Baseline Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O2">
            <title>80% Food Energy Density</title>
            <description>Lower Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O3">
            <title>120% Food Energy Density</title>
            <description>Higher Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Energy</title>
          <description>Differences in daily intake of food and beverages by energy, in kcal</description>
          <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
          <units>kilocalories</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="956" spread="37"/>
                    <measurement group_id="O2" value="884" spread="38"/>
                    <measurement group_id="O3" value="1041" spread="38"/>
                  </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>
            <p_value_desc>According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.</p_value_desc>
            <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 intake of food and beverages by weight, in grams</description>
        <time_frame>Days 1-5 in weeks 1, 2, and 3</time_frame>
        <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
        <group_list>
          <group group_id="O1">
            <title>100% Food Energy Density</title>
            <description>Baseline Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O2">
            <title>80% Food Energy Density</title>
            <description>Lower Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O3">
            <title>120% Food Energy Density</title>
            <description>Higher Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Weight</title>
          <description>Differences in daily intake of food and beverages by weight, in grams</description>
          <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="997" spread="41"/>
                    <measurement group_id="O2" value="952" spread="41"/>
                    <measurement group_id="O3" value="988" spread="41"/>
                  </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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.10</p_value>
            <p_value_desc>According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.</p_value_desc>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <p_value_desc>According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.</p_value_desc>
            <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 intake of food and beverages by energy density, in kcal/g</description>
        <time_frame>Days 1-5 in weeks 1, 2, and 3</time_frame>
        <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
        <group_list>
          <group group_id="O1">
            <title>100% Food Energy Density</title>
            <description>Baseline Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O2">
            <title>80% Food Energy Density</title>
            <description>Lower Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
          <group group_id="O3">
            <title>120% Food Energy Density</title>
            <description>Higher Food Energy Density&#xD;
Food Energy Density: Food Energy density manipulated</description>
          </group>
        </group_list>
        <measure>
          <title>Differences in Food and Beverage Intake by Energy Density</title>
          <description>Differences in daily intake of food and beverages by energy density, in kcal/g</description>
          <population>Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.</population>
          <units>kilocalories/gram</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.02"/>
                    <measurement group_id="O2" value="0.93" spread="0.02"/>
                    <measurement group_id="O3" value="1.06" spread="0.03"/>
                  </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>
            <p_value_desc>According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.</p_value_desc>
            <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>80% Food Energy Density</title>
          <description>All participants during the 80% Food Energy Density intervention</description>
        </group>
        <group group_id="E2">
          <title>100% Food Energy Density</title>
          <description>All participants during the 100% Food Energy Density intervention</description>
        </group>
        <group group_id="E3">
          <title>120% Food Energy Density</title>
          <description>All participants during the 120% Food Energy Density intervention</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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </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="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </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/NCT03010501
org study id: ChildFood502
secondary id: R01DK082580
nct id: NCT03010501
lead sponsor: 
collaborator: 
has dmc: No
In this study, the investigators will vary the energy density of foods served during three
      5-day periods. There will be a baseline condition, and then a condition where the energy
      density of food is lower and a condition where the energy density of food is higher. The
      primary aim is to determine the effect of varying the energy density of foods served over 5
      days on energy intake in preschool children. It is hypothesized that mean daily energy intake
      will be greater when children are served higher energy dense foods over 5 days than when
      served lower energy dense foods over the same period. Additionally, it is hypothesized that
      daily energy intake in the conditions with higher and lower energy densities 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: Days 1-5 in Weeks 1, 2, and 3
description: Differences in daily intake of food and beverages by energy, in kcal
measure: Differences in Food and Beverage Intake by Weight
time frame: Days 1-5 in weeks 1, 2, and 3
description: Differences in daily intake of food and beverages by weight, in grams
measure: Differences in Food and Beverage Intake by Energy Density
time frame: Days 1-5 in weeks 1, 2, and 3
description: Differences in daily intake of food and beverages by energy density, in kcal/g
arm group label: 100% Food Energy Density
arm group type: Experimental
description: Baseline Food Energy Density
arm group label: 80% Food Energy Density
arm group type: Experimental
description: Lower Food Energy Density
arm group label: 120% Food Energy Density
arm group type: Experimental
description: Higher Food Energy Density
intervention type: Other
intervention name: Food Energy Density
description: Food Energy density manipulated
arm group label: 100% Food Energy Density
arm group label: 120% Food Energy Density
arm group label: 80% Food Energy Density
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
last name: Barbara J Rolls
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: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 