<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/NCT03294590</url>
  </required_header>
  <id_info>
    <org_study_id>H-36857</org_study_id>
    <secondary_id>4UH3DE025492-03</secondary_id>
    <nct_id>NCT03294590</nct_id>
  </id_info>
  <brief_title>Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children</brief_title>
  <acronym>iSmile</acronym>
  <official_title>Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized clinical trial to test the efficacy of a parent-targeted text&#xD;
      message-based intervention program on caries incidence and oral health behaviors (child and&#xD;
      parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and&#xD;
      Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman&#xD;
      Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or&#xD;
      TMs regarding child wellness. The study will enroll English and Spanish speaking parents and&#xD;
      their youngest child who is &lt; 7 years old, has at least one tooth showing, and attends the&#xD;
      targeted pediatric clinic to receive primary care (n= 1700). Parents will complete&#xD;
      self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and&#xD;
      respond to TM assessments during the 4-month intervention; and will also receive TMs during a&#xD;
      'booster' period of one month, which will occur 12-months post baseline. Parent's children&#xD;
      will be assessed for caries by a clinical oral examination performed by licensed Clinical&#xD;
      Examiners at baseline, 12-and-24-months post-baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2018</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Outcome Assessors and Oral Health Examiners will be blind to treatment condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dental Caries Increment</measure>
    <time_frame>24-month time point (oral assessment)</time_frame>
    <description>Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent/Caregiver Confidence to Brush</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent/Caregiver Motivation to Perform Oral Health Behaviors</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent/Caregiver Outcome Expectations for Oral Health Behaviors</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy to Perform Oral Health Behaviors</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental Caries Increment (Surface Level)</measure>
    <time_frame>24-month time point (oral assessment)</time_frame>
    <description>Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Text Message Program Length Satisfaction</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' Perceived Impact of iSmile</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Preventive Dental Visits</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoridated Toothpaste Use</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Impact of OHT Program on Parental Awareness</measure>
    <time_frame>24-month (survey)</time_frame>
    <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Diet - Food Frequency</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Diet - Beverage Intake</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Tooth Brushing</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Caregiver Tooth Brushing</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Oral Health-related Quality of Life</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Text Message Program Features</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Toothbrushing (Clinical Guidelines)</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into &quot;child met clinical guidelines for brushing&quot; (brushing at least two times per day, seven days of the week) vs not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents/Caregivers Toothbrushing (Clinical Guidelines)</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into &quot;parent/caregiver participants met clinical guidelines for brushing&quot; (brushed at least two times per day, seven days of the week) vs not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diffusion of Text Messages (Satisfaction)</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Text Message Program Star Rating</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Text Message Program Quality</measure>
    <time_frame>4-month time point (survey)</time_frame>
    <description>Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Type of Beverage Consumed Between Meals</measure>
    <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
    <description>Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.</description>
  </other_outcome>
  <other_outcome>
    <measure>Challenge Week During the OHT Text Message Program</measure>
    <time_frame>4-month time point</time_frame>
    <description>We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dental Caries (Per Subject)</measure>
    <time_frame>24-Month (oral health assessment)</time_frame>
    <description>Number of primary teeth with new dental caries per child</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">754</enrollment>
  <condition>Caries, Dental</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Oral health text messages (OHT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child wellness text messages (CWT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OHT Parent targeted text messages</intervention_name>
    <description>For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
    <arm_group_label>Oral health text messages (OHT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CWT Parent targeted text messages</intervention_name>
    <description>For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
    <arm_group_label>Child wellness text messages (CWT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Caregiver and child must meet all of the following:&#xD;
&#xD;
          1. Caregiver must be a parent or legal guardian of a child less than 7 years old, and the&#xD;
             child must have their first tooth showing&#xD;
&#xD;
          2. The child must receive medical care at one of the participating pediatric clinics.&#xD;
&#xD;
          3. Speak, understand, and read either English or Spanish&#xD;
&#xD;
          4. Have a mobile phone.&#xD;
&#xD;
        Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad&#xD;
        will be excluded from participation in this study&#xD;
&#xD;
          1. Children with severe congenital tooth malformations: At screening the caregiver will&#xD;
             be asked if their child has known systemic diseases associated with abnormal tooth&#xD;
             development or abnormal oral health status such as cleft lip or palate, amelogenesis&#xD;
             imperfecta, or dentinogenesis imperfecta.&#xD;
&#xD;
          2. Children who cannot complete the baseline oral health exam.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Belinda Borrelli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry M. Goldman School of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>February 1, 2023</results_first_submitted>
  <results_first_submitted_qc>May 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2023</results_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child oral health behaviors</keyword>
  <keyword>Text messages</keyword>
  <keyword>Motivation</keyword>
  <keyword>Self efficacy</keyword>
  <keyword>Outcome Expectations</keyword>
  <keyword>Sugar sweetened beverage consumption</keyword>
  <keyword>Fluoride varnish</keyword>
  <keyword>Healthy eating</keyword>
  <keyword>Parent oral health behaviors</keyword>
  <keyword>Parent oral health attitudes</keyword>
  <keyword>Fluoride</keyword>
  <keyword>early childhood caries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>March 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03294590/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03294590/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>754 dyads (parents or caregivers and child) were enrolled and randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oral Health Text Messages (OHT)</title>
          <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
        </group>
        <group group_id="P2">
          <title>Child Wellness Text Messages (CWT)</title>
          <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="377"/>
                <participants group_id="P2" count="377"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Parent/Caregiver Participants</title>
              <participants_list>
                <participants group_id="P1" count="377"/>
                <participants group_id="P2" count="377"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Children Participants</title>
              <participants_list>
                <participants group_id="P1" count="377"/>
                <participants group_id="P2" count="377"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>4-month Time Point (Survey)</title>
              <participants_list>
                <participants group_id="P1" count="290">Number of parents/caregivers completing the 4-month questionnaire assessment</participants>
                <participants group_id="P2" count="288">Number of parents/caregivers completing the 4-month questionnaire assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>12-month Time Point (Survey)</title>
              <participants_list>
                <participants group_id="P1" count="282">Number of parents/caregivers completing the 12-month questionnaire assessment</participants>
                <participants group_id="P2" count="290">Number of parents/caregivers completing the 12-month questionnaire assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>12-month Time Point (Oral Exam)</title>
              <participants_list>
                <participants group_id="P1" count="206">Number of children completing the 12-month oral health exam</participants>
                <participants group_id="P2" count="185">Number of children completing the 12-month oral health exam</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>24-month Time Point (Survey)</title>
              <participants_list>
                <participants group_id="P1" count="272">Number of parents/caregivers completing the 24-month questionnaire assessment</participants>
                <participants group_id="P2" count="270">Number of parents/caregivers completing the 24-month questionnaire assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>24-month Time Point (Oral Exam)</title>
              <participants_list>
                <participants group_id="P1" count="160">Number of children completing the 24-month oral health exam</participants>
                <participants group_id="P2" count="156">Number of children completing the 24-month oral health exam</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="272"/>
                <participants group_id="P2" count="270"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="107"/>
              </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="105"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>754 parent/caregiver-child dyads were assessed for baseline measures (total 1,508 participants)</population>
      <group_list>
        <group group_id="B1">
          <title>Oral Health Text Messages (OHT)</title>
          <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
        </group>
        <group group_id="B2">
          <title>Child Wellness Text Messages (CWT)</title>
          <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</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="754"/>
            <count group_id="B2" value="754"/>
            <count group_id="B3" value="1508"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Mean age of parent/caregiver and children participants</description>
          <population>754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Parent/caregiver participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="7.0"/>
                    <measurement group_id="B2" value="33.0" spread="7.4"/>
                    <measurement group_id="B3" value="32.9" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" spread="1.7"/>
                    <measurement group_id="B2" value="2.8" spread="1.6"/>
                    <measurement group_id="B3" value="2.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Sex of parent/caregiver and children participants</description>
          <population>754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Parent/caregiver participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="358"/>
                    <measurement group_id="B2" value="355"/>
                    <measurement group_id="B3" value="713"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="377"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Ethnicity of parent/caregiver and children participants</description>
          <population>754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Parent/caregiver participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="270"/>
                    <measurement group_id="B2" value="270"/>
                    <measurement group_id="B3" value="540"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="227"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="251"/>
                    <measurement group_id="B3" value="503"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Race of parent/caregiver and children participants</description>
          <population>754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Parent/caregiver participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="235"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="440"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Children participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="377"/>
                    <count group_id="B2" value="377"/>
                    <count group_id="B3" value="754"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="225"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="424"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="754"/>
                    <count group_id="B2" value="754"/>
                    <count group_id="B3" value="1508"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="754"/>
                    <measurement group_id="B2" value="754"/>
                    <measurement group_id="B3" value="1508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Dental Caries Increment</title>
        <description>Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
        <time_frame>24-month time point (oral assessment)</time_frame>
        <population>Number of children with any new dental caries in primary teeth (using multiple imputation methods to account for missing oral health assessment data at 24-month)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Caries Increment</title>
          <description>Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
          <population>Number of children with any new dental caries in primary teeth (using multiple imputation methods to account for missing oral health assessment data at 24-month)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parent/Caregiver Confidence to Brush</title>
        <description>9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Scores on a self-efficacy measure (range 1 - 4; higher scores mean better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Caregiver Confidence to Brush</title>
          <description>9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)</description>
          <population>Scores on a self-efficacy measure (range 1 - 4; higher scores mean better outcome)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.2"/>
                    <measurement group_id="O2" value="2.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parent/Caregiver Motivation to Perform Oral Health Behaviors</title>
        <description>A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Scores on a motivation measure (range 1 - 7; higher scores mean better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Caregiver Motivation to Perform Oral Health Behaviors</title>
          <description>A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)</description>
          <population>Scores on a motivation measure (range 1 - 7; higher scores mean better outcome)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="1.2"/>
                    <measurement group_id="O2" value="6.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parent/Caregiver Outcome Expectations for Oral Health Behaviors</title>
        <description>An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Scores on an outcome expectancies measure (range 1 - 4; higher scores mean better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Caregiver Outcome Expectations for Oral Health Behaviors</title>
          <description>An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).</description>
          <population>Scores on an outcome expectancies measure (range 1 - 4; higher scores mean better outcome)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="0.67"/>
                    <measurement group_id="O2" value="3.68" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-efficacy to Perform Oral Health Behaviors</title>
        <description>The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Scores on a confidence (self-efficacy) measure (range 1 - 7; higher scores mean better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy to Perform Oral Health Behaviors</title>
          <description>The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).</description>
          <population>Scores on a confidence (self-efficacy) measure (range 1 - 7; higher scores mean better outcome)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.1"/>
                    <measurement group_id="O2" value="6.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dental Caries Increment (Surface Level)</title>
        <description>Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
        <time_frame>24-month time point (oral assessment)</time_frame>
        <population>Number of tooth surfaces with new caries in children participants</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Caries Increment (Surface Level)</title>
          <description>Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).</description>
          <population>Number of tooth surfaces with new caries in children participants</population>
          <units>Tooth surfaces</units>
          <param>Count of Units</param>
          <units_analyzed>Tooth surfaces</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Tooth surfaces</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13553"/>
                <count group_id="O2" value="13477"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545"/>
                    <measurement group_id="O2" value="496"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Text Message Program Length Satisfaction</title>
        <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. Text message program length satisfaction assessed the number of parent/caregiver participants who selected each response option to: &quot;You've been receiving the iSmile text messages for about four months. What do you think about the length of the program?&quot;</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Text Message Program Length Satisfaction</title>
          <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.</description>
          <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. Text message program length satisfaction assessed the number of parent/caregiver participants who selected each response option to: &quot;You've been receiving the iSmile text messages for about four months. What do you think about the length of the program?&quot;</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>It was just about right</title>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The program should last longer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The program should be shorter</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parents' Perceived Impact of iSmile</title>
        <description>Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Parent/caregiver participants in the OHT arm responded to &quot;How much do you think iSmile had a positive impact on?&quot;.. (1='not at all' to 7='very much'; higher scores mean a better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>OHT Group</title>
            <description>Subjects receive oral health text messages (brushing, visiting the dentist, fluoride, reducing sugar sweetened beverages and healthy eating, bedtime routing, and bottle/sippy cup use)</description>
          </group>
        </group_list>
        <measure>
          <title>Parents' Perceived Impact of iSmile</title>
          <description>Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).</description>
          <population>Parent/caregiver participants in the OHT arm responded to &quot;How much do you think iSmile had a positive impact on?&quot;.. (1='not at all' to 7='very much'; higher scores mean a better outcome)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Making sure your child's teeth are brushed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreasing the amount of sugar-sweetened beverages your child drinks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Your feelings on taking your child to the dentist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Preventive Dental Visits</title>
        <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants who indicated that their child had a preventive dental visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Preventive Dental Visits</title>
          <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.</description>
          <population>Number of parent/caregiver participants who indicated that their child had a preventive dental visit.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                    <measurement group_id="O2" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fluoridated Toothpaste Use</title>
        <description>One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants indicating use of fluoridated toothpaste to brush their child's teeth.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Fluoridated Toothpaste Use</title>
          <description>One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.</description>
          <population>Number of parent/caregiver participants indicating use of fluoridated toothpaste to brush their child's teeth.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225"/>
                    <measurement group_id="O2" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229"/>
                    <measurement group_id="O2" value="215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225"/>
                    <measurement group_id="O2" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Impact of OHT Program on Parental Awareness</title>
        <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.</description>
        <time_frame>24-month (survey)</time_frame>
        <population>Number of parent/caregiver participants in the OHT arm endorsing each response category in response to: &quot;iSmile has increased my awareness of my child's oral health (1='strongly disagree, to 5='strongly agree')</population>
        <group_list>
          <group group_id="O1">
            <title>OHT Group</title>
            <description>Subjects received oral health text messages (brushing, visiting the dentist, fluoride, reducing sugar sweetened beverages and healthy eating, bedtime routing, and bottle/sippy cup use)</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Impact of OHT Program on Parental Awareness</title>
          <description>One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.</description>
          <population>Number of parent/caregiver participants in the OHT arm endorsing each response category in response to: &quot;iSmile has increased my awareness of my child's oral health (1='strongly disagree, to 5='strongly agree')</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 - strongly disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 -</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 -</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 -</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 - strongly agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Diet - Food Frequency</title>
        <description>Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>The estimated cariogenic score derived from a food frequency questionnaire (higher scores mean a worse outcome).</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Diet - Food Frequency</title>
          <description>Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).</description>
          <population>The estimated cariogenic score derived from a food frequency questionnaire (higher scores mean a worse outcome).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.31"/>
                    <measurement group_id="O2" value="2.27" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.30"/>
                    <measurement group_id="O2" value="2.23" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.18" spread="0.28"/>
                    <measurement group_id="O2" value="2.22" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Diet - Beverage Intake</title>
        <description>Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants indicating that their child consumed higher sugar sweetened beverages including 100% fruit juice (=&quot;more than 4.5 fluid ounces per day&quot;).</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Diet - Beverage Intake</title>
          <description>Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).</description>
          <population>Number of parent/caregiver participants indicating that their child consumed higher sugar sweetened beverages including 100% fruit juice (=&quot;more than 4.5 fluid ounces per day&quot;).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Tooth Brushing</title>
        <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of child tooth brushings per week (range: 0 - 21; higher scores mean a better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Tooth Brushing</title>
          <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
          <population>Number of child tooth brushings per week (range: 0 - 21; higher scores mean a better outcome)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="4.5"/>
                    <measurement group_id="O2" value="11.1" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="4.4"/>
                    <measurement group_id="O2" value="11.6" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" spread="3.7"/>
                    <measurement group_id="O2" value="11.3" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Caregiver Tooth Brushing</title>
        <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants tooth brushings per week (range: 0 - 21; higher scores mean a better outcome).</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Caregiver Tooth Brushing</title>
          <description>An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).</description>
          <population>Number of parent/caregiver participants tooth brushings per week (range: 0 - 21; higher scores mean a better outcome).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="3.8"/>
                    <measurement group_id="O2" value="12.3" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="4.2"/>
                    <measurement group_id="O2" value="12.5" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="3.8"/>
                    <measurement group_id="O2" value="12.4" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Oral Health-related Quality of Life</title>
        <description>The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>The Early Childhood Oral Health 'Family' Impact scale score (range 0 - 16; higher scores mean a worse outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Oral Health-related Quality of Life</title>
          <description>The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).</description>
          <population>The Early Childhood Oral Health 'Family' Impact scale score (range 0 - 16; higher scores mean a worse outcome)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="2.00"/>
                    <measurement group_id="O2" value="0.99" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="2.03"/>
                    <measurement group_id="O2" value="0.96" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.55"/>
                    <measurement group_id="O2" value="0.80" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Text Message Program Features</title>
        <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Average level of satisfaction with text message program features (1='not satisfied at all', to 7='very much satisfied'; higher scores mean a better outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Text Message Program Features</title>
          <description>One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).</description>
          <population>Average level of satisfaction with text message program features (1='not satisfied at all', to 7='very much satisfied'; higher scores mean a better outcome)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.12" spread="1.27"/>
                    <measurement group_id="O2" value="6.04" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Child Toothbrushing (Clinical Guidelines)</title>
        <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into &quot;child met clinical guidelines for brushing&quot; (brushing at least two times per day, seven days of the week) vs not.</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants who indicated that they brushed or supervised brushing their child's teeth at least two times per day, seven days of the week.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Child Toothbrushing (Clinical Guidelines)</title>
          <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into &quot;child met clinical guidelines for brushing&quot; (brushing at least two times per day, seven days of the week) vs not.</description>
          <population>Number of parent/caregiver participants who indicated that they brushed or supervised brushing their child's teeth at least two times per day, seven days of the week.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parents/Caregivers Toothbrushing (Clinical Guidelines)</title>
        <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into &quot;parent/caregiver participants met clinical guidelines for brushing&quot; (brushed at least two times per day, seven days of the week) vs not.</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants who indicated that they brushed their teeth at least two times per day, seven days of the week.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Parents/Caregivers Toothbrushing (Clinical Guidelines)</title>
          <description>An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into &quot;parent/caregiver participants met clinical guidelines for brushing&quot; (brushed at least two times per day, seven days of the week) vs not.</description>
          <population>Number of parent/caregiver participants who indicated that they brushed their teeth at least two times per day, seven days of the week.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195"/>
                    <measurement group_id="O2" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diffusion of Text Messages (Satisfaction)</title>
        <description>One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. Diffusion of text messages assessed the number of parents/caregivers who showed (or forwarded) text messages to others.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Diffusion of Text Messages (Satisfaction)</title>
          <description>One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else</description>
          <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. Diffusion of text messages assessed the number of parents/caregivers who showed (or forwarded) text messages to others.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Text Message Program Star Rating</title>
        <description>One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. The text message program star rating assessed the number of parent/caregiver participants who rated the text message program between 1 star and 5 stars.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Text Message Program Star Rating</title>
          <description>One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.</description>
          <population>The iSmile study consisted of &quot;oral health&quot; text messages for parent/caregiver participants in the OHT arm, and &quot;child wellness&quot; text messages for parent/caregiver participants in the CWT arm. The text message program star rating assessed the number of parent/caregiver participants who rated the text message program between 1 star and 5 stars.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 star</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 stars</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 stars</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 stars</title>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 stars</title>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Text Message Program Quality</title>
        <description>Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).</description>
        <time_frame>4-month time point (survey)</time_frame>
        <population>Parent/caregiver participants were asked 6 questions assessing the quality of the text messages (TMs) received during the program. Ratings were given on a 1 to 7 scale (higher scores mean a better outcome).</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Text Message Program Quality</title>
          <description>Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).</description>
          <population>Parent/caregiver participants were asked 6 questions assessing the quality of the text messages (TMs) received during the program. Ratings were given on a 1 to 7 scale (higher scores mean a better outcome).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Relevant to cultural background</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.81" spread="1.65"/>
                    <measurement group_id="O2" value="5.56" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age appropriate for child</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="1.4"/>
                    <measurement group_id="O2" value="6.0" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Content of TMs easy to understand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="1.1"/>
                    <measurement group_id="O2" value="6.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to integrate into day/routine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="1.2"/>
                    <measurement group_id="O2" value="6.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Language appropriate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="1.1"/>
                    <measurement group_id="O2" value="6.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relevant for you and your child</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="1.4"/>
                    <measurement group_id="O2" value="6.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of Beverage Consumed Between Meals</title>
        <description>Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.</description>
        <time_frame>4-month, 12-month, and 24-month time points (survey)</time_frame>
        <population>Number of parent/caregiver participants indicating that their child consumed the beverage between meals.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Type of Beverage Consumed Between Meals</title>
          <description>Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.</description>
          <population>Number of parent/caregiver participants indicating that their child consumed the beverage between meals.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
                <count group_id="O2" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1. Cow's milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2. Juice or juice drinks</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3. Diet soda pop or other sugar free beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4. Water</title>
                  <measurement_list>
                    <measurement group_id="O1" value="164"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5. Regular soda pop or other sugared beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6. Flavored milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7. Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Do not know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="282"/>
                    <count group_id="O2" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1. Cow's milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2. Juice or juice drinks</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3. Diet soda pop or other sugar free beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4. Water</title>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5. Regular soda pop or other sugared beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6. Flavored milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7. Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Do not know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1. Cow's milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2. Juice or juice drinks</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3. Diet soda pop or other sugar free beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4. Water</title>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5. Regular soda pop or other sugared beverages</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6. Flavored milk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7. Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Do not know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Challenge Week During the OHT Text Message Program</title>
        <description>We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.</description>
        <time_frame>4-month time point</time_frame>
        <population>Number of parent/caregiver participants in the OHT arm who agreed to do the challenge.</population>
        <group_list>
          <group group_id="O1">
            <title>OHT Group</title>
            <description>Subjects receive oral health text messages (brushing, visiting the dentist, fluoride, reducing sugar sweetened beverages and healthy eating, bedtime routing, and bottle/sippy cup use)</description>
          </group>
        </group_list>
        <measure>
          <title>Challenge Week During the OHT Text Message Program</title>
          <description>We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.</description>
          <population>Number of parent/caregiver participants in the OHT arm who agreed to do the challenge.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="377"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Challenge one</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Challenge two</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Dental Caries (Per Subject)</title>
        <description>Number of primary teeth with new dental caries per child</description>
        <time_frame>24-Month (oral health assessment)</time_frame>
        <population>Number of primary teeth with new dental caries per child</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Health Text Messages (OHT)</title>
            <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
          </group>
          <group group_id="O2">
            <title>Child Wellness Text Messages (CWT)</title>
            <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
          </group>
        </group_list>
        <measure>
          <title>Dental Caries (Per Subject)</title>
          <description>Number of primary teeth with new dental caries per child</description>
          <population>Number of primary teeth with new dental caries per child</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 teeth with new caries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 tooth with new caries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 teeth with new caries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 to 5 teeth with new caries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 or more teeth with new caries</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Oral Health Text Messages (OHT)</title>
          <description>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.&#xD;
OHT Parent targeted text messages: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.</description>
        </group>
        <group group_id="E2">
          <title>Child Wellness Text Messages (CWT)</title>
          <description>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.&#xD;
CWT Parent targeted text messages: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Death - Probably not related to a study device</sub_title>
                <description>Study team made a retention call for a follow-up survey on 10/14/20. A family member picked up and informed us that the parent/caregiver participant had died. No other details were disclosed. Study team ascertained that the death occurred 02/15/20.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="377"/>
                <counts group_id="E2" subjects_at_risk="377"/>
              </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="377"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="377"/>
              </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>
    <limitations_and_caveats>Due to the COVID-19 pandemic, on March 12, 2020 Boston University Medical campus and Boston Medical Center IRB declared an immediate halt of in-person research activities. This resulted in a less than expected number of children attending the 12 and/or the 24 month oral health assessments.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Belinda Borrelli, PhD</name_or_title>
      <organization>Boston University Henry M. Goldman School of Dental Medicine</organization>
      <phone>617-358-3358</phone>
      <email>belindab@bu.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/NCT03294590
org study id: H-36857
secondary id: 4UH3DE025492-03
nct id: NCT03294590
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized clinical trial to test the efficacy of a parent-targeted text
      message-based intervention program on caries incidence and oral health behaviors (child and
      parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and
      Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman
      Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or
      TMs regarding child wellness. The study will enroll English and Spanish speaking parents and
      their youngest child who is < 7 years old, has at least one tooth showing, and attends the
      targeted pediatric clinic to receive primary care (n= 1700). Parents will complete
      self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and
      respond to TM assessments during the 4-month intervention; and will also receive TMs during a
      'booster' period of one month, which will occur 12-months post baseline. Parent's children
      will be assessed for caries by a clinical oral examination performed by licensed Clinical
      Examiners at baseline, 12-and-24-months post-baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: Outcome Assessors and Oral Health Examiners will be blind to treatment condition.
measure: Dental Caries Increment
time frame: 24-month time point (oral assessment)
description: Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
measure: Parent/Caregiver Confidence to Brush
time frame: 4-month time point (survey)
description: 9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)
measure: Parent/Caregiver Motivation to Perform Oral Health Behaviors
time frame: 4-month time point (survey)
description: A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)
measure: Parent/Caregiver Outcome Expectations for Oral Health Behaviors
time frame: 4-month time point (survey)
description: An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).
measure: Self-efficacy to Perform Oral Health Behaviors
time frame: 4-month time point (survey)
description: The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).
measure: Dental Caries Increment (Surface Level)
time frame: 24-month time point (oral assessment)
description: Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
measure: Text Message Program Length Satisfaction
time frame: 4-month time point (survey)
description: One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
measure: Parents' Perceived Impact of iSmile
time frame: 4-month time point (survey)
description: Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).
measure: Child Preventive Dental Visits
time frame: 4-month, 12-month, and 24-month time points (survey)
description: One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.
measure: Fluoridated Toothpaste Use
time frame: 4-month, 12-month, and 24-month time points (survey)
description: One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.
measure: Perceived Impact of OHT Program on Parental Awareness
time frame: 24-month (survey)
description: One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.
measure: Child Diet - Food Frequency
time frame: 4-month, 12-month, and 24-month time points (survey)
description: Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).
measure: Child Diet - Beverage Intake
time frame: 4-month, 12-month, and 24-month time points (survey)
description: Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).
measure: Child Tooth Brushing
time frame: 4-month, 12-month, and 24-month time points (survey)
description: An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).
measure: Parent/Caregiver Tooth Brushing
time frame: 4-month, 12-month, and 24-month time points (survey)
description: An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).
measure: Child Oral Health-related Quality of Life
time frame: 4-month, 12-month, and 24-month time points (survey)
description: The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).
measure: Satisfaction With Text Message Program Features
time frame: 4-month time point (survey)
description: One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).
measure: Child Toothbrushing (Clinical Guidelines)
time frame: 4-month, 12-month, and 24-month time points (survey)
description: An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into "child met clinical guidelines for brushing" (brushing at least two times per day, seven days of the week) vs not.
measure: Parents/Caregivers Toothbrushing (Clinical Guidelines)
time frame: 4-month, 12-month, and 24-month time points (survey)
description: An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into "parent/caregiver participants met clinical guidelines for brushing" (brushed at least two times per day, seven days of the week) vs not.
measure: Diffusion of Text Messages (Satisfaction)
time frame: 4-month time point (survey)
description: One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
measure: Text Message Program Star Rating
time frame: 4-month time point (survey)
description: One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.
measure: Text Message Program Quality
time frame: 4-month time point (survey)
description: Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).
measure: Type of Beverage Consumed Between Meals
time frame: 4-month, 12-month, and 24-month time points (survey)
description: Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
measure: Challenge Week During the OHT Text Message Program
time frame: 4-month time point
description: We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.
measure: Dental Caries (Per Subject)
time frame: 24-Month (oral health assessment)
description: Number of primary teeth with new dental caries per child
arm group label: Oral health text messages (OHT)
arm group type: Experimental
description: Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.
arm group label: Child wellness text messages (CWT)
arm group type: Active Comparator
description: Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.
intervention type: Other
intervention name: OHT Parent targeted text messages
description: For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.
arm group label: Oral health text messages (OHT)
intervention type: Other
intervention name: CWT Parent targeted text messages
description: For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.
arm group label: Child wellness text messages (CWT)
criteria: 
gender: All
minimum age: 0 Months
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Belinda Borrelli, PhD
role: Principal Investigator
affiliation: Henry M. Goldman School of Dental Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dental Caries
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the COVID-19 pandemic, on March 12, 2020 Boston University Medical campus and Boston Medical Center IRB declared an immediate halt of in-person research activities. This resulted in a less than expected number of children attending the 12 and/or the 24 month oral health assessments.
point of contact: 