<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/NCT01667549</url>
  </required_header>
  <id_info>
    <org_study_id>HD37119</org_study_id>
    <nct_id>NCT01667549</nct_id>
  </id_info>
  <brief_title>Sensitive Periods in Human Flavor Learning</brief_title>
  <official_title>Sensitive Periods in Human Flavor Learning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Monell Chemical Senses Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Monell Chemical Senses Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of the proposed research are to specify the timing and consequences of the&#xD;
      sensitive period for flavor learning in infants who are being breastfed or formula fed. The&#xD;
      investigators will conduct a randomized within- and between-subject study of women and their&#xD;
      infants during a 15-month window.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial on both breastfeeding and formula feeding infants to&#xD;
      determine the effects of the timing of flavor experiences on subsequent food acceptance in&#xD;
      both members of the dyad.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">November 30, 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vegetable Flavor Acceptance [Infants' Intake]</measure>
    <time_frame>6- to 10-month-old weaned infants (3 separate test days )</time_frame>
    <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste Liking Ratings of Vegetable Flavors [Mothers].</measure>
    <time_frame>Monthly, 0.5 to 4.5 months</time_frame>
    <description>Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vegetable Flavor Acceptance (Infants' Rate of Feeding)</measure>
    <time_frame>6- to 10-month-old weaned infants (3 separate test days)</time_frame>
    <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal Perceptions</measure>
    <time_frame>6- to 10-month-old weaned infants (3 separate test days)</time_frame>
    <description>Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth of Infants</measure>
    <time_frame>Once a month from ages 0.5 - 4.5 months, 10.5 months</time_frame>
    <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Development</condition>
  <arm_group>
    <arm_group_label>1M0.5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1M1.5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3M0.5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mothers will not receive the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Timing of Diet and Flavor Experience</intervention_name>
    <description>Groups differ in the timing and duration of exposure to flavored food experience.</description>
    <arm_group_label>1M0.5</arm_group_label>
    <arm_group_label>1M1.5</arm_group_label>
    <arm_group_label>3M0.5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, term infants and their mothers&#xD;
&#xD;
          -  Infants 2 wks (+/- 2 wk of age)&#xD;
&#xD;
          -  Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based&#xD;
             formula&#xD;
&#xD;
          -  Mothers must be older than 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants who were preterm or have medical conditions that interfere with feeding or&#xD;
             eating&#xD;
&#xD;
          -  Mothers who had gestational diabetes or are diagnosed with a major illness requiring&#xD;
             treatment or surgery&#xD;
&#xD;
          -  Mothers who will be going back to work full-time before the infant is 4 months old&#xD;
&#xD;
          -  Mothers who are allergic to any vegetables&#xD;
&#xD;
          -  Subjects will not be excluded because of economic status, gender, race or ethnicity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>3 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie A Mennella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monell Chemical Senses Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monell Chemical Senses Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mennella JA, Jagnow CP, Beauchamp GK. Prenatal and postnatal flavor learning by human infants. Pediatrics. 2001 Jun;107(6):E88. doi: 10.1542/peds.107.6.e88.</citation>
    <PMID>11389286</PMID>
  </reference>
  <reference>
    <citation>Skinner JD, Carruth BR, Wendy B, Ziegler PJ. Children's food preferences: a longitudinal analysis. J Am Diet Assoc. 2002 Nov;102(11):1638-47. doi: 10.1016/s0002-8223(02)90349-4.</citation>
    <PMID>12449287</PMID>
  </reference>
  <reference>
    <citation>Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.</citation>
    <PMID>21310829</PMID>
  </reference>
  <reference>
    <citation>Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005 Feb;115(2):e216-22. doi: 10.1542/peds.2004-1582.</citation>
    <PMID>15687429</PMID>
  </reference>
  <reference>
    <citation>Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.</citation>
    <PMID>18055673</PMID>
  </reference>
  <reference>
    <citation>Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6.</citation>
    <PMID>21672566</PMID>
  </reference>
  <reference>
    <citation>Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.</citation>
    <PMID>1489209</PMID>
  </reference>
  <reference>
    <citation>Gerrish CJ, Mennella JA. Flavor variety enhances food acceptance in formula-fed infants. Am J Clin Nutr. 2001 Jun;73(6):1080-5. doi: 10.1093/ajcn/73.6.1080.</citation>
    <PMID>11382663</PMID>
  </reference>
  <reference>
    <citation>Mennella JA, Nicklaus S, Jagolino AL, Yourshaw LM. Variety is the spice of life: strategies for promoting fruit and vegetable acceptance during infancy. Physiol Behav. 2008 Apr 22;94(1):29-38. doi: 10.1016/j.physbeh.2007.11.014. Epub 2007 Nov 21.</citation>
    <PMID>18222499</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>January 17, 2019</results_first_submitted>
  <results_first_submitted_qc>November 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 9, 2019</results_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Monell Chemical Senses Center</investigator_affiliation>
    <investigator_full_name>Julie A. Mennella, PhD</investigator_full_name>
    <investigator_title>Member and Director Emeritus</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Flavor learning</keyword>
  <keyword>Mother</keyword>
  <keyword>Moms</keyword>
  <keyword>Infants</keyword>
  <keyword>Babies</keyword>
  <keyword>Baby</keyword>
  <keyword>Food Habits</keyword>
  <keyword>Fruits</keyword>
  <keyword>Vegetables</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Pregnant women or newly parturient women who intended to breastfeed their infants exclusively for at least 4 months were recruited from ads in local newspapers, websites, and Philadelphia Women, Infants, and Children (WIC) offices. We enroll mother -infant dyads because both members of the dyads were tested.</recruitment_details>
      <pre_assignment_details>No mother-infant dyads were excluded from the study prior to assignment to groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>1M0.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="P2">
          <title>1M1.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="P3">
          <title>1M2.5</title>
          <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age</description>
        </group>
        <group group_id="P4">
          <title>3M0.5</title>
          <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="P5">
          <title>Control</title>
          <description>Mothers will not receive the intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20">20 dyads=20 infants, 20 mothers</participants>
                <participants group_id="P2" count="20">20 dyads=20 infants, 20 mothers</participants>
                <participants group_id="P3" count="21">21 dyads=21 infants, 21 mothers</participants>
                <participants group_id="P4" count="20">20 dyads= 20 infants, 20 mothers</participants>
                <participants group_id="P5" count="16">16 dyads=16 infants, 16 mothers</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17">17 dyads=17 infants, 17 mothers</participants>
                <participants group_id="P2" count="15">15 dyads=15 infants, 15 mothers</participants>
                <participants group_id="P3" count="14">14 dyads=14 infants, 14 mothers</participants>
                <participants group_id="P4" count="14">14 dyads= 14 infants, 14 mothers</participants>
                <participants group_id="P5" count="15">15 dyads=15 infants, 15 mothers</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The number of baseline participants refers to number of infants or number of mothers, depending on outcome</population>
      <group_list>
        <group group_id="B1">
          <title>1M0.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="B2">
          <title>1M1.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="B3">
          <title>1M2.5</title>
          <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="B4">
          <title>3M0.5</title>
          <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="B5">
          <title>Control</title>
          <description>Mothers will not receive the intervention.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="16"/>
            <count group_id="B6" value="97"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Dyads consists of mothers and their infants and different measures were obtained from each.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Infants' Age in months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.5" spread="0.1"/>
                    <measurement group_id="B2" value="0.6" spread="0.1"/>
                    <measurement group_id="B3" value="0.6" spread="0.1"/>
                    <measurement group_id="B4" value="0.6" spread="0.1"/>
                    <measurement group_id="B5" value="0.5" spread="0.1"/>
                    <measurement group_id="B6" value="0.5" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Mothers' Age in years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.5" spread="4.4"/>
                    <measurement group_id="B2" value="30.5" spread="6.2"/>
                    <measurement group_id="B3" value="29.8" spread="5.2"/>
                    <measurement group_id="B4" value="29.9" spread="5.1"/>
                    <measurement group_id="B5" value="31.7" spread="5.9"/>
                    <measurement group_id="B6" value="30.8" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>The genotype of infants are reported separately from mothers. Genotyping was attempted but failed for one infant.</description>
          <population>Infants are reported separately from mothers</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Sex of Infants</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex of Mothers</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Infants are reported separately from mothers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Infants</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mothers</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Infants are reported separately from mothers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Infants</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mothers</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Genotype, TAS2R38 taste gene [secondary outcome]</title>
          <population>Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Infants</title>
              <category_list>
                <category>
                  <title>TAS2R38 genotype, AA [non taster]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TAS2R38 genotype AP [taster, heterozygote]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TAS2R38 genotype PP [taster]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotyping unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mothers</title>
              <category_list>
                <category>
                  <title>TAS2R38 genotype, AA [non taster]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TAS2R38 genotype AP [taster, heterozygote]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>TAS2R38 genotype PP [taster]</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotyping unsuccessful</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Vegetable Flavor Acceptance [Infants' Intake]</title>
        <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).</description>
        <time_frame>6- to 10-month-old weaned infants (3 separate test days )</time_frame>
        <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group</population>
        <group_list>
          <group group_id="O1">
            <title>1M0.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O2">
            <title>1M1.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O3">
            <title>1M2.5</title>
            <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age</description>
          </group>
          <group group_id="O4">
            <title>3M0.5</title>
            <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O5">
            <title>Control</title>
            <description>Mothers will not receive the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Vegetable Flavor Acceptance [Infants' Intake]</title>
          <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).</description>
          <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group</population>
          <units>intake in 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="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intake of plain cereal in grams</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" spread="13.2"/>
                    <measurement group_id="O2" value="42.4" spread="12.4"/>
                    <measurement group_id="O3" value="29.0" spread="8.5"/>
                    <measurement group_id="O4" value="40.7" spread="8.3"/>
                    <measurement group_id="O5" value="36.5" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intake of carrot cereal in grams</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.2" spread="14.8"/>
                    <measurement group_id="O2" value="36.6" spread="10.0"/>
                    <measurement group_id="O3" value="57.7" spread="19.9"/>
                    <measurement group_id="O4" value="52.2" spread="9.8"/>
                    <measurement group_id="O5" value="41.1" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intake of broccoli cereal, grams</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8" spread="12.7"/>
                    <measurement group_id="O2" value="25.5" spread="8.8"/>
                    <measurement group_id="O3" value="30.9" spread="10.1"/>
                    <measurement group_id="O4" value="34.4" spread="12.4"/>
                    <measurement group_id="O5" value="3.04" spread="6.5"/>
                  </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>O4</group_id>
            </group_id_list>
            <groups_desc>Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).</non_inferiority_desc>
            <p_value>0.02</p_value>
            <p_value_desc>Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.</p_value_desc>
            <method>planned comparison</method>
            <method_desc>Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Taste Liking Ratings of Vegetable Flavors [Mothers].</title>
        <description>Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).</description>
        <time_frame>Monthly, 0.5 to 4.5 months</time_frame>
        <population>Two mothers did not complete the ratings on one test date.</population>
        <group_list>
          <group group_id="O1">
            <title>1M0.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O2">
            <title>1M1.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O3">
            <title>1M2.5</title>
            <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age</description>
          </group>
          <group group_id="O4">
            <title>3M0.5</title>
            <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O5">
            <title>Control</title>
            <description>Mothers will not receive the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Taste Liking Ratings of Vegetable Flavors [Mothers].</title>
          <description>Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).</description>
          <population>Two mothers did not complete the ratings on one test date.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Carrot, 0.5 mos (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="4.84"/>
                    <measurement group_id="O2" value="-3.35" spread="5.15"/>
                    <measurement group_id="O3" value="-1.28" spread="5.33"/>
                    <measurement group_id="O4" value="-2.02" spread="5.33"/>
                    <measurement group_id="O5" value="-4.71" spread="5.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carrot, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.21" spread="3.41"/>
                    <measurement group_id="O2" value="1.28" spread="3.63"/>
                    <measurement group_id="O3" value="3.91" spread="3.75"/>
                    <measurement group_id="O4" value="4.17" spread="3.75"/>
                    <measurement group_id="O5" value="1.46" spread="3.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carrot, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="3.19"/>
                    <measurement group_id="O2" value="3.51" spread="3.39"/>
                    <measurement group_id="O3" value="2.08" spread="3.51"/>
                    <measurement group_id="O4" value="6.30" spread="3.51"/>
                    <measurement group_id="O5" value="-2.53" spread="3.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carrot, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.10" spread="3.36"/>
                    <measurement group_id="O2" value="6.20" spread="3.71"/>
                    <measurement group_id="O3" value="7.78" spread="3.7"/>
                    <measurement group_id="O4" value="3.05" spread="3.71"/>
                    <measurement group_id="O5" value="1.56" spread="3.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carrot, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.86" spread="3.35"/>
                    <measurement group_id="O2" value="4.82" spread="3.69"/>
                    <measurement group_id="O3" value="6.20" spread="3.69"/>
                    <measurement group_id="O4" value="2.63" spread="3.69"/>
                    <measurement group_id="O5" value="2.75" spread="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beet, 0.5 mos (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.81" spread="5.37"/>
                    <measurement group_id="O2" value="1.18" spread="5.72"/>
                    <measurement group_id="O3" value="-0.65" spread="5.92"/>
                    <measurement group_id="O4" value="0.87" spread="5.92"/>
                    <measurement group_id="O5" value="-3.21" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beet, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.13" spread="4.16"/>
                    <measurement group_id="O2" value="9.35" spread="4.43"/>
                    <measurement group_id="O3" value="-2.20" spread="4.58"/>
                    <measurement group_id="O4" value="3.40" spread="4.58"/>
                    <measurement group_id="O5" value="5.73" spread="4.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beet, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.29" spread="3.50"/>
                    <measurement group_id="O2" value="6.41" spread="3.73"/>
                    <measurement group_id="O3" value="-0.68" spread="3.86"/>
                    <measurement group_id="O4" value="1.02" spread="3.86"/>
                    <measurement group_id="O5" value="9.17" spread="3.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beet, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.87" spread="3.94"/>
                    <measurement group_id="O2" value="7.74" spread="4.34"/>
                    <measurement group_id="O3" value="7.54" spread="4.34"/>
                    <measurement group_id="O4" value="3.52" spread="4.34"/>
                    <measurement group_id="O5" value="6.82" spread="4.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beet, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.63" spread="3.48"/>
                    <measurement group_id="O2" value="10.34" spread="3.83"/>
                    <measurement group_id="O3" value="9.35" spread="3.83"/>
                    <measurement group_id="O4" value="3.58" spread="3.83"/>
                    <measurement group_id="O5" value="7.89" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Vegetables, 0.5 mos (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="5.05"/>
                    <measurement group_id="O2" value="0.20" spread="5.38"/>
                    <measurement group_id="O3" value="0.82" spread="5.57"/>
                    <measurement group_id="O4" value="0.97" spread="5.57"/>
                    <measurement group_id="O5" value="11.32" spread="5.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Vegetables, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.48" spread="3.96"/>
                    <measurement group_id="O2" value="0.18" spread="4.22"/>
                    <measurement group_id="O3" value="1.11" spread="4.36"/>
                    <measurement group_id="O4" value="4.30" spread="4.36"/>
                    <measurement group_id="O5" value="10.69" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Vegetables, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.19" spread="3.31"/>
                    <measurement group_id="O2" value="6.32" spread="3.52"/>
                    <measurement group_id="O3" value="2.23" spread="3.65"/>
                    <measurement group_id="O4" value="6.14" spread="3.65"/>
                    <measurement group_id="O5" value="7.57" spread="3.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Vegetables, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.00" spread="3.52"/>
                    <measurement group_id="O2" value="5.69" spread="3.88"/>
                    <measurement group_id="O3" value="3.81" spread="3.88"/>
                    <measurement group_id="O4" value="6.01" spread="3.88"/>
                    <measurement group_id="O5" value="10.42" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Vegetables, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.40" spread="3.32"/>
                    <measurement group_id="O2" value="6.83" spread="3.66"/>
                    <measurement group_id="O3" value="1.02" spread="3.66"/>
                    <measurement group_id="O4" value="3.62" spread="3.66"/>
                    <measurement group_id="O5" value="7.87" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celery, 0.5 mos (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="4.72"/>
                    <measurement group_id="O2" value="-5.33" spread="5.02"/>
                    <measurement group_id="O3" value="-13.35" spread="5.20"/>
                    <measurement group_id="O4" value="-12.46" spread="5.20"/>
                    <measurement group_id="O5" value="-10.36" spread="5.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celery, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.93" spread="3.86"/>
                    <measurement group_id="O2" value="-0.90" spread="3.92"/>
                    <measurement group_id="O3" value="-13.48" spread="4.06"/>
                    <measurement group_id="O4" value="-9.68" spread="4.06"/>
                    <measurement group_id="O5" value="-5.44" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celery, 2.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="3.99"/>
                    <measurement group_id="O2" value="-0.51" spread="4.24"/>
                    <measurement group_id="O3" value="-3.01" spread="4.39"/>
                    <measurement group_id="O4" value="-6.20" spread="4.39"/>
                    <measurement group_id="O5" value="-2.88" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celery, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.12" spread="3.72"/>
                    <measurement group_id="O2" value="1.07" spread="4.10"/>
                    <measurement group_id="O3" value="-10.40" spread="4.10"/>
                    <measurement group_id="O4" value="-8.07" spread="4.10"/>
                    <measurement group_id="O5" value="-6.69" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celery, 4.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.15" spread="3.77"/>
                    <measurement group_id="O2" value="-1.44" spread="4.16"/>
                    <measurement group_id="O3" value="-5.89" spread="4.16"/>
                    <measurement group_id="O4" value="-5.87" spread="4.16"/>
                    <measurement group_id="O5" value="-2.91" spread="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apple, 0.5 mos (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.85" spread="3.64"/>
                    <measurement group_id="O2" value="17.48" spread="3.88"/>
                    <measurement group_id="O3" value="22.41" spread="4.02"/>
                    <measurement group_id="O4" value="14.57" spread="4.02"/>
                    <measurement group_id="O5" value="23.72" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apple, 1.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.04" spread="2.98"/>
                    <measurement group_id="O2" value="20.08" spread="3.17"/>
                    <measurement group_id="O3" value="11.81" spread="3.28"/>
                    <measurement group_id="O4" value="18.23" spread="3.28"/>
                    <measurement group_id="O5" value="20.36" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apple, 2.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.09" spread="2.95"/>
                    <measurement group_id="O2" value="15.97" spread="3.15"/>
                    <measurement group_id="O3" value="17.91" spread="3.26"/>
                    <measurement group_id="O4" value="16.72" spread="3.26"/>
                    <measurement group_id="O5" value="19.39" spread="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apple, 3.5 mos</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.39" spread="3.52"/>
                    <measurement group_id="O2" value="22.56" spread="3.88"/>
                    <measurement group_id="O3" value="17.01" spread="3.88"/>
                    <measurement group_id="O4" value="19.56" spread="3.88"/>
                    <measurement group_id="O5" value="19.44" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apple, 4.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.89" spread="2.73"/>
                    <measurement group_id="O2" value="19.87" spread="3.01"/>
                    <measurement group_id="O3" value="15.45" spread="3.01"/>
                    <measurement group_id="O4" value="19.94" spread="3.01"/>
                    <measurement group_id="O5" value="22.06" spread="2.91"/>
                  </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>O4</group_id>
            </group_id_list>
            <groups_desc>Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.02</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vegetable Flavor Acceptance (Infants' Rate of Feeding)</title>
        <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .</description>
        <time_frame>6- to 10-month-old weaned infants (3 separate test days)</time_frame>
        <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group.</population>
        <group_list>
          <group group_id="O1">
            <title>1M0.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O2">
            <title>1M1.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O3">
            <title>1M2.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 2.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O4">
            <title>3M0.5</title>
            <description>Mothers received the intervention for 3 months beginning when their infant was 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O5">
            <title>Control</title>
            <description>Mothers did not receive the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Vegetable Flavor Acceptance (Infants' Rate of Feeding)</title>
          <description>Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .</description>
          <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group.</population>
          <units>grams per minute</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rate of feeding, plain cereal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="0.9"/>
                    <measurement group_id="O2" value="3.9" spread="1.1"/>
                    <measurement group_id="O3" value="4.0" spread="0.8"/>
                    <measurement group_id="O4" value="4.3" spread="0.4"/>
                    <measurement group_id="O5" value="4.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate of feeding, carrot cereal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="1.1"/>
                    <measurement group_id="O2" value="3.6" spread="0.8"/>
                    <measurement group_id="O3" value="4.8" spread="1.3"/>
                    <measurement group_id="O4" value="3.9" spread="0.5"/>
                    <measurement group_id="O5" value="3.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate of feeding, broccoli cereal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="0.8"/>
                    <measurement group_id="O2" value="2.4" spread="0.9"/>
                    <measurement group_id="O3" value="4.5" spread="1.0"/>
                    <measurement group_id="O4" value="3.8" spread="0.9"/>
                    <measurement group_id="O5" value="4.1" spread="0.8"/>
                  </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>O4</group_id>
            </group_id_list>
            <groups_desc>Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).</non_inferiority_desc>
            <p_value>&lt;0.02</p_value>
            <p_value_desc>Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's&lt;0.02 were considered significant.</p_value_desc>
            <method>planned comparison</method>
            <method_desc>a Bonferroni adjustment was calculated and only planned comparison with P's&lt;0.02 were considered significant.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maternal Perceptions</title>
        <description>Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).</description>
        <time_frame>6- to 10-month-old weaned infants (3 separate test days)</time_frame>
        <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number of maternal ratings analyzed differs from number in each group</population>
        <group_list>
          <group group_id="O1">
            <title>1M0.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O2">
            <title>1M1.5</title>
            <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O3">
            <title>1M2.5</title>
            <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age</description>
          </group>
          <group group_id="O4">
            <title>3M0.5</title>
            <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O5">
            <title>Control</title>
            <description>Mothers will not receive the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Perceptions</title>
          <description>Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).</description>
          <population>Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number of maternal ratings analyzed differs from number in each group</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rating of infant enjoyment, plain cerea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="0.6"/>
                    <measurement group_id="O2" value="4.6" spread="0.8"/>
                    <measurement group_id="O3" value="4.1" spread="0.9"/>
                    <measurement group_id="O4" value="5.2" spread="0.6"/>
                    <measurement group_id="O5" value="3.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rating of infant enjoyment, carrot cereal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="0.7"/>
                    <measurement group_id="O2" value="4.7" spread="0.7"/>
                    <measurement group_id="O3" value="7.1" spread="0.4"/>
                    <measurement group_id="O4" value="6.1" spread="0.5"/>
                    <measurement group_id="O5" value="6.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rating of infant enjoyment, broccoli cere</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.7"/>
                    <measurement group_id="O2" value="2.9" spread="0.6"/>
                    <measurement group_id="O3" value="4.7" spread="0.7"/>
                    <measurement group_id="O4" value="4.3" spread="0.6"/>
                    <measurement group_id="O5" value="4.1" spread="0.7"/>
                  </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>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.02</p_value>
            <p_value_desc>Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P&lt;0.02 were considered significant.</p_value_desc>
            <method>planned comparison</method>
            <method_desc>A Bonferroni adjustment was calculated and only planned comparison with P's&lt;0.02 were considered significant.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Growth of Infants</title>
        <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
        <time_frame>Once a month from ages 0.5 - 4.5 months, 10.5 months</time_frame>
        <population>Number of infants who were weighted and measured to determine Weight for Length Z scores (WLZ) during trial; some dyads did not complete the trial so number of participants analyzed does not always match number enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>1M0.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O2">
            <title>1M1.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O3">
            <title>1M2.5</title>
            <description>Mothers received the intervention for 1 month beginning when their infant was 2.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O4">
            <title>3M0.5</title>
            <description>Mothers received the intervention for 3 months beginning when their infant was 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
          </group>
          <group group_id="O5">
            <title>Control</title>
            <description>Mothers did not receive the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Growth of Infants</title>
          <description>At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).</description>
          <population>Number of infants who were weighted and measured to determine Weight for Length Z scores (WLZ) during trial; some dyads did not complete the trial so number of participants analyzed does not always match number enrolled.</population>
          <units>Z score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight for Length Z: 0.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.24"/>
                    <measurement group_id="O2" value="0.04" spread="0.26"/>
                    <measurement group_id="O3" value="-0.40" spread="0.27"/>
                    <measurement group_id="O4" value="0.10" spread="0.27"/>
                    <measurement group_id="O5" value="-0.56" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z: 1.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.27"/>
                    <measurement group_id="O2" value="0.42" spread="0.28"/>
                    <measurement group_id="O3" value="-0.49" spread="0.29"/>
                    <measurement group_id="O4" value="0.56" spread="0.29"/>
                    <measurement group_id="O5" value="0.14" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z: 2.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.26"/>
                    <measurement group_id="O2" value="0.13" spread="0.29"/>
                    <measurement group_id="O3" value="-0.64" spread="0.29"/>
                    <measurement group_id="O4" value="0.45" spread="0.29"/>
                    <measurement group_id="O5" value="0.15" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z: 3.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.28"/>
                    <measurement group_id="O2" value="0.12" spread="0.31"/>
                    <measurement group_id="O3" value="-0.68" spread="0.31"/>
                    <measurement group_id="O4" value="0.63" spread="0.31"/>
                    <measurement group_id="O5" value="0.08" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z: 4.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.25"/>
                    <measurement group_id="O2" value="0.05" spread="0.27"/>
                    <measurement group_id="O3" value="-0.67" spread="0.27"/>
                    <measurement group_id="O4" value="0.43" spread="0.27"/>
                    <measurement group_id="O5" value="0.30" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight for Length Z, 10.5 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.24"/>
                    <measurement group_id="O2" value="0.67" spread="0.26"/>
                    <measurement group_id="O3" value="0.23" spread="0.26"/>
                    <measurement group_id="O4" value="0.61" spread="0.26"/>
                    <measurement group_id="O5" value="0.54" spread="0.25"/>
                  </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>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>1M0.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="E2">
          <title>1M1.5</title>
          <description>Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="E3">
          <title>1M2.5</title>
          <description>Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age</description>
        </group>
        <group group_id="E4">
          <title>3M0.5</title>
          <description>Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.&#xD;
Intervention: Timing of Diet and Flavor Experience&#xD;
Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience.</description>
        </group>
        <group group_id="E5">
          <title>Control</title>
          <description>Mothers will not receive the 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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </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>Julia A. Mennella, PhD; Study Principal Investigator</name_or_title>
      <organization>Monell Chemical Senses Center</organization>
      <phone>267-519-4880</phone>
      <email>mennella@monell.org</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/NCT01667549
org study id: HD37119
nct id: NCT01667549
lead sponsor: 
has dmc: No
The goals of the proposed research are to specify the timing and consequences of the
      sensitive period for flavor learning in infants who are being breastfed or formula fed. The
      investigators will conduct a randomized within- and between-subject study of women and their
      infants during a 15-month window.
This is a randomized clinical trial on both breastfeeding and formula feeding infants to
      determine the effects of the timing of flavor experiences on subsequent food acceptance in
      both members of the dyad.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Vegetable Flavor Acceptance [Infants' Intake]
time frame: 6- to 10-month-old weaned infants (3 separate test days )
description: Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).
measure: Taste Liking Ratings of Vegetable Flavors [Mothers].
time frame: Monthly, 0.5 to 4.5 months
description: Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).
measure: Vegetable Flavor Acceptance (Infants' Rate of Feeding)
time frame: 6- to 10-month-old weaned infants (3 separate test days)
description: Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .
measure: Maternal Perceptions
time frame: 6- to 10-month-old weaned infants (3 separate test days)
description: Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).
measure: Growth of Infants
time frame: Once a month from ages 0.5 - 4.5 months, 10.5 months
description: At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
arm group label: 1M0.5
arm group type: Experimental
description: Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.
Intervention: Timing of Diet and Flavor Experience
arm group label: 1M1.5
arm group type: Experimental
description: Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.
Intervention: Timing of Diet and Flavor Experience
arm group label: 3M0.5
arm group type: Experimental
description: Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.
Intervention: Timing of Diet and Flavor Experience
arm group label: Control
arm group type: No Intervention
description: Mothers will not receive the intervention.
intervention type: Other
intervention name: Timing of Diet and Flavor Experience
description: Groups differ in the timing and duration of exposure to flavored food experience.
arm group label: 1M0.5
arm group label: 1M1.5
arm group label: 3M0.5
criteria: 
gender: All
minimum age: 2 Weeks
maximum age: 3 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Julie A Mennella, PhD
role: Principal Investigator
affiliation: Monell Chemical Senses Center
facility: 
country: United States
citation: Mennella JA, Jagnow CP, Beauchamp GK. Prenatal and postnatal flavor learning by human infants. Pediatrics. 2001 Jun;107(6):E88. doi: 10.1542/peds.107.6.e88.
PMID: 11389286
citation: Skinner JD, Carruth BR, Wendy B, Ziegler PJ. Children's food preferences: a longitudinal analysis. J Am Diet Assoc. 2002 Nov;102(11):1638-47. doi: 10.1016/s0002-8223(02)90349-4.
PMID: 12449287
citation: Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.
PMID: 21310829
citation: Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005 Feb;115(2):e216-22. doi: 10.1542/peds.2004-1582.
PMID: 15687429
citation: Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.
PMID: 18055673
citation: Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6.
PMID: 21672566
citation: Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.
PMID: 1489209
citation: Gerrish CJ, Mennella JA. Flavor variety enhances food acceptance in formula-fed infants. Am J Clin Nutr. 2001 Jun;73(6):1080-5. doi: 10.1093/ajcn/73.6.1080.
PMID: 11382663
citation: Mennella JA, Nicklaus S, Jagolino AL, Yourshaw LM. Variety is the spice of life: strategies for promoting fruit and vegetable acceptance during infancy. Physiol Behav. 2008 Apr 22;94(1):29-38. doi: 10.1016/j.physbeh.2007.11.014. Epub 2007 Nov 21.
PMID: 18222499
responsible party type: Principal Investigator
investigator affiliation: Monell Chemical Senses Center
investigator full name: Julie A. Mennella, PhD
investigator title: Member and Director Emeritus
mesh term: Hypersensitivity
sharing ipd: No
ipd description: There is not a plan to make IPD available
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 