<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/NCT04502979</url>
  </required_header>
  <id_info>
    <org_study_id>15-2437</org_study_id>
    <secondary_id>R21HD082707</secondary_id>
    <nct_id>NCT04502979</nct_id>
  </id_info>
  <brief_title>Learning to Love Mealtime Together</brief_title>
  <acronym>LiTTLe Me</acronym>
  <official_title>Enhancing Caregiver-Infant Communication to Prevent Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infancy is an important target period for obesity prevention because once obese as an infant,&#xD;
      the relative risk of remaining obese appears to rise with increasing age at great cost to&#xD;
      both individuals and society. The ability to self-regulate energy intake (eating when hungry&#xD;
      and stopping when full) is vital to obesity prevention and it is thought that this ability&#xD;
      can be derailed by a chronic mismatch between parental feeding behavior and the infant's&#xD;
      state (feeding in the absence of hunger and/or feeding beyond fullness). The study will test&#xD;
      a novel intervention to help parents and pre-verbal infants better understand one another&#xD;
      during feeding and it will offer new insight into how self-regulation of energy intake&#xD;
      develops during infancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once obese as an infant, the relative risk of remaining obese appears to rise with increasing&#xD;
      age. Thus, the early years of life have been posited as an important target period for&#xD;
      obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental&#xD;
      factors, obesity fundamentally reflects an imbalance between energy intake and expenditure.&#xD;
      Self-regulation of energy intake aligned with physiologic need is essential to this balance.&#xD;
      The process(es) by which infants begin to disassociate eating behavior from physiologic need&#xD;
      is unclear, thus it is crucial to better understand predictors of individual differences in&#xD;
      self-regulation of energy intake. It is well established that autonomic regulation may&#xD;
      support infant behavioral regulation, suggesting that autonomic function may be a critical&#xD;
      area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction&#xD;
      quality during infancy, and findings reveal that more responsive interactions are associated&#xD;
      with more effective autonomic regulation. A chronic mismatch between a caregiver's feeding&#xD;
      behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond&#xD;
      fullness), is thought to contribute to obesity by undermining the infant's capacity to&#xD;
      self-regulate intake; the current proposal will be the first to examine the effects on&#xD;
      autonomic regulation. The investigators propose an intervention to enrich the capacity of&#xD;
      mother-infant dyads to perform their respective interactive tasks. The investigators plan to&#xD;
      teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety,&#xD;
      which they will in turn teach their preverbal infant. This training in ASL will be augmented&#xD;
      with targeted information for mothers about infants' capacities to self-regulate energy&#xD;
      intake in response to hunger and satiety and communicate those states with intention. Mothers&#xD;
      also will be taught about expected development of infants' eating behaviors and nutritional&#xD;
      requirements to support healthy growth.&#xD;
&#xD;
      Using a two-group randomized repeated measures design, this study aims to 1) evaluate the&#xD;
      feasibility and acceptability of the intervention and study methods, including recruitment,&#xD;
      enrollment, and data collection (self-report, anthropometrics, video observations, and&#xD;
      respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial&#xD;
      impact of the intervention on observed feeding interactions, reported infant feeding&#xD;
      behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth;&#xD;
      and, 3) explore preliminary data on concordance between dyadic feeding interactions and&#xD;
      autonomic regulation in both mothers and infants (RSA). In addition to a variety of&#xD;
      self-report and anthropometric measures, this study will use integrated behavioral (video)&#xD;
      and physiologic (RSA) measures to better understand feeding dynamics and their relationship&#xD;
      with obesity risk. Understanding these processes is essential for developing appropriate&#xD;
      preventions, or interventions, that will help reduce the prevalence of early childhood&#xD;
      obesity and its extension into later childhood and beyond.&#xD;
&#xD;
      Study Phases:&#xD;
&#xD;
      Screening: screening for eligibility and obtaining consent&#xD;
&#xD;
      Study Treatment: study intervention/experimental treatment from baseline visit ([Time 1&#xD;
      (T1)]: age 4-9-months) monthly until 3-months post-baseline ([Time 2 (T2)]: age 7-12-months)&#xD;
&#xD;
      Follow-up: 6-months post-baseline ([Time 3 (T3)]: age 10-15-months)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant Weight-for-Length Z Scores</measure>
    <time_frame>6 Months Post-Baseline (T3)</time_frame>
    <description>The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Infant Caloric Intake Compared to Estimated Energy Requirements</measure>
    <time_frame>6 Months Post-Baseline (T3)</time_frame>
    <description>Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements. Lower values represent greater precision of intake.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Infant Obesity</condition>
  <condition>Parenting</condition>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>Responsive Feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables]55], and appropriate portion sizes and variety for healthy growth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Responsive Feeding Training</intervention_name>
    <description>Families will receive 4 monthly 1-hour sessions: (1) Signing with infants; (2) infant communication and responsive feeding; (3) nutrition, portion sizes, and neophobia; and, (4) infant intentionality.</description>
    <arm_group_label>Responsive Feeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Parent Inclusion:&#xD;
&#xD;
          -  Must be able to read, understand, and speak English or Spanish and be willing to be&#xD;
             randomized and participate in data collection.&#xD;
&#xD;
          -  Those who are randomized into the experimental group must also be willing to learn ASL&#xD;
             specific to communication of hunger, thirst, and fullness.&#xD;
&#xD;
        Infant Inclusion:&#xD;
&#xD;
          -  Aged at least 3 months at the time of recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Parent Exclusion:&#xD;
&#xD;
          -  &gt; 50 years of age&#xD;
&#xD;
        Infant Exclusion:&#xD;
&#xD;
          -  Aged more than 9 months at the time of recruitment&#xD;
&#xD;
          -  born more than 6 weeks earlier than their estimated due date,&#xD;
&#xD;
          -  have any developmental delays or disabilities that make it difficult for them to eat,&#xD;
             drink, or communicate,&#xD;
&#xD;
          -  attend regular daycare,&#xD;
&#xD;
          -  will be younger than 4 months or older than 9 months at the time of the first ASL&#xD;
             training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>9 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Hodges, PhD, FNP-BC, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>August 26, 2020</results_first_submitted>
  <results_first_submitted_qc>September 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 11, 2020</results_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infant Obesity</keyword>
  <keyword>Parenting</keyword>
  <keyword>Feeding Behavior</keyword>
  <keyword>Responsive Feeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).</ipd_description>
    <ipd_time_frame>9 to 36 months following publication</ipd_time_frame>
    <ipd_access_criteria>The investigator proposing to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT04502979/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Responsive Feeding</title>
          <description>Intervention families will receive approximately 4 hours of American Sign Language (ASL) and development-specific content related to language and feeding during home visits and phone calls. The initial in-home session with families focused on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs are left with families at the end of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.</description>
        </group>
        <group group_id="P2">
          <title>Routine Care</title>
          <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Responsive Feeding</title>
          <description>Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.</description>
        </group>
        <group group_id="B2">
          <title>Routine Care</title>
          <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</description>
        </group>
        <group group_id="B3">
          <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="37"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.86" spread="1.57"/>
                    <measurement group_id="B2" value="7.29" spread="1.64"/>
                    <measurement group_id="B3" value="7.07" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="63"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Infant Weight-for-Length Z Scores</title>
        <description>The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.</description>
        <time_frame>6 Months Post-Baseline (T3)</time_frame>
        <population>Measurement error resulted in improbable length data (length recorded as shorter than length at prior visit when infant was younger) for 10 infants total (Responsive Feeding n = 6; Routine Care n = 4). Data for these 10 infants were excluded from analysis at T3.</population>
        <group_list>
          <group group_id="O1">
            <title>Responsive Feeding</title>
            <description>Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.</description>
          </group>
          <group group_id="O2">
            <title>Routine Care</title>
            <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Weight-for-Length Z Scores</title>
          <description>The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.</description>
          <population>Measurement error resulted in improbable length data (length recorded as shorter than length at prior visit when infant was younger) for 10 infants total (Responsive Feeding n = 6; Routine Care n = 4). Data for these 10 infants were excluded from analysis at T3.</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="28"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.15"/>
                    <measurement group_id="O2" value="0.12" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <p_value_desc>One-sided p-value for directional hypothesis. The threshold for statistical significance is p &lt; 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Infant Caloric Intake Compared to Estimated Energy Requirements</title>
        <description>Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements. Lower values represent greater precision of intake.</description>
        <time_frame>6 Months Post-Baseline (T3)</time_frame>
        <population>All data reported were included (missing for 13 infants).</population>
        <group_list>
          <group group_id="O1">
            <title>Responsive Feeding</title>
            <description>Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.</description>
          </group>
          <group group_id="O2">
            <title>Routine Care</title>
            <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Infant Caloric Intake Compared to Estimated Energy Requirements</title>
          <description>Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements. Lower values represent greater precision of intake.</description>
          <population>All data reported were included (missing for 13 infants).</population>
          <units>Kcal</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.90" spread="43.37"/>
                    <measurement group_id="O2" value="242.06" spread="48.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <p_value_desc>One-sided p-value for directional hypothesis. The threshold for statistical significance is p &lt; 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-121.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>65.73</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-252.73</ci_lower_limit>
            <ci_upper_limit>10.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline through Study Completion, an approximate total of 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Responsive Feeding</title>
          <description>Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables], and appropriate portion sizes and variety for healthy growth.</description>
        </group>
        <group group_id="E2">
          <title>Routine Care</title>
          <description>No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.</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="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </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="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Eric A Hodges, PhD, FNC-BC, FAAN</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-0534</phone>
      <email>eahodges@email.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502979
org study id: 15-2437
secondary id: R21HD082707
nct id: NCT04502979
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infancy is an important target period for obesity prevention because once obese as an infant,
      the relative risk of remaining obese appears to rise with increasing age at great cost to
      both individuals and society. The ability to self-regulate energy intake (eating when hungry
      and stopping when full) is vital to obesity prevention and it is thought that this ability
      can be derailed by a chronic mismatch between parental feeding behavior and the infant's
      state (feeding in the absence of hunger and/or feeding beyond fullness). The study will test
      a novel intervention to help parents and pre-verbal infants better understand one another
      during feeding and it will offer new insight into how self-regulation of energy intake
      develops during infancy.
Once obese as an infant, the relative risk of remaining obese appears to rise with increasing
      age. Thus, the early years of life have been posited as an important target period for
      obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental
      factors, obesity fundamentally reflects an imbalance between energy intake and expenditure.
      Self-regulation of energy intake aligned with physiologic need is essential to this balance.
      The process(es) by which infants begin to disassociate eating behavior from physiologic need
      is unclear, thus it is crucial to better understand predictors of individual differences in
      self-regulation of energy intake. It is well established that autonomic regulation may
      support infant behavioral regulation, suggesting that autonomic function may be a critical
      area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction
      quality during infancy, and findings reveal that more responsive interactions are associated
      with more effective autonomic regulation. A chronic mismatch between a caregiver's feeding
      behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond
      fullness), is thought to contribute to obesity by undermining the infant's capacity to
      self-regulate intake; the current proposal will be the first to examine the effects on
      autonomic regulation. The investigators propose an intervention to enrich the capacity of
      mother-infant dyads to perform their respective interactive tasks. The investigators plan to
      teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety,
      which they will in turn teach their preverbal infant. This training in ASL will be augmented
      with targeted information for mothers about infants' capacities to self-regulate energy
      intake in response to hunger and satiety and communicate those states with intention. Mothers
      also will be taught about expected development of infants' eating behaviors and nutritional
      requirements to support healthy growth.

      Using a two-group randomized repeated measures design, this study aims to 1) evaluate the
      feasibility and acceptability of the intervention and study methods, including recruitment,
      enrollment, and data collection (self-report, anthropometrics, video observations, and
      respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial
      impact of the intervention on observed feeding interactions, reported infant feeding
      behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth;
      and, 3) explore preliminary data on concordance between dyadic feeding interactions and
      autonomic regulation in both mothers and infants (RSA). In addition to a variety of
      self-report and anthropometric measures, this study will use integrated behavioral (video)
      and physiologic (RSA) measures to better understand feeding dynamics and their relationship
      with obesity risk. Understanding these processes is essential for developing appropriate
      preventions, or interventions, that will help reduce the prevalence of early childhood
      obesity and its extension into later childhood and beyond.

      Study Phases:

      Screening: screening for eligibility and obtaining consent

      Study Treatment: study intervention/experimental treatment from baseline visit ([Time 1
      (T1)]: age 4-9-months) monthly until 3-months post-baseline ([Time 2 (T2)]: age 7-12-months)

      Follow-up: 6-months post-baseline ([Time 3 (T3)]: age 10-15-months)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Infant Weight-for-Length Z Scores
time frame: 6 Months Post-Baseline (T3)
description: The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.
measure: Mean Infant Caloric Intake Compared to Estimated Energy Requirements
time frame: 6 Months Post-Baseline (T3)
description: Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements. Lower values represent greater precision of intake.
arm group label: Responsive Feeding
arm group type: Experimental
description: Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes [many vegetables]55], and appropriate portion sizes and variety for healthy growth.
arm group label: Routine Care
arm group type: No Intervention
description: No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
intervention type: Behavioral
intervention name: Responsive Feeding Training
description: Families will receive 4 monthly 1-hour sessions: (1) Signing with infants; (2) infant communication and responsive feeding; (3) nutrition, portion sizes, and neophobia; and, (4) infant intentionality.
arm group label: Responsive Feeding
criteria: 
gender: All
minimum age: 3 Months
maximum age: 9 Months
healthy volunteers: No
last name: Eric Hodges, PhD, FNP-BC, FAAN
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).
ipd time frame: 9 to 36 months following publication
ipd access criteria: The investigator proposing to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 