<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/NCT02244424</url>
  </required_header>
  <id_info>
    <org_study_id>1R21HDO75974-OIAL</org_study_id>
    <nct_id>NCT02244424</nct_id>
  </id_info>
  <brief_title>Tools For Teen Moms: Reducing Infant Obesity Risk</brief_title>
  <acronym>TFTM</acronym>
  <official_title>Tools for Teen Moms: Reducing Infant Obesity Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michigan State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Michigan State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this social media group randomized trial (GRT) is to test the feasibility of&#xD;
      our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues&#xD;
      and implement healthy feeding practices through development of a healthy feeding style.&#xD;
&#xD;
      Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered&#xD;
      to the target population as it relates to their acceptance and satisfaction with the content,&#xD;
      format, delivery, and use of social media.&#xD;
&#xD;
      Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of&#xD;
      infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and&#xD;
      feeding practices evaluated at the completion of the intervention using self-report methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid weight gain during infancy is one of the strongest risk factors for obesity later in&#xD;
      childhood. Weight gain in infancy is closely linked with feeding practices. Unhealthy&#xD;
      mother-infant feeding practices contribute to rapid and/or excessive infant weight gain.&#xD;
      Lower-income, adolescent, first-time mothers are less likely to engage in infant-centered&#xD;
      feeding (ICF) which is characterized by maternal responsiveness (MR), healthy feeding styles&#xD;
      (FS), and healthy feeding practices (FP). ICF is needed to reduce rapid/excessive weight gain&#xD;
      during the first six months of life and to foster infant feeding self-regulation that is&#xD;
      associated with healthy growth. ICF is a critical factor in reducing infant obesity risk and&#xD;
      later adverse health conditions. Practical early intervention strategies are necessary to&#xD;
      promote ICF among adolescent mothers to reduce obesity risk. We propose Baby Dayr, a novel&#xD;
      social media intervention platform designed by the investigators which includes cell phone&#xD;
      text message reminders, an infant feeding website, and Facebook to increase ICF through daily&#xD;
      behavioral challenge activities (&quot;challenges&quot;) for this population. Because cell phones&#xD;
      permit natural, frequent and non-intrusive contact as they are not time-or-place-dependent,&#xD;
      they offer an innovative strategy for intervening with adolescent mothers. However, this&#xD;
      approach is untested for its feasibility with this population regarding infant feeding&#xD;
      practices. We propose an exploratory, longitudinal, randomized, two-group study design. The&#xD;
      three specific aims are: 1) to establish preliminary efficacy of the intervention as assessed&#xD;
      by infant growth evaluated pre-intervention, immediately post intervention, and when the&#xD;
      infant is six months old; 2) establish preliminary efficacy of the Baby Dayr plus&#xD;
      Maternal-Infant Health Program (MIHP) care vs. MIHP care only on infant-centered feeding (MR,&#xD;
      FS, and FP) mediated by maternal knowledge and self-efficacy; and 3) establish the&#xD;
      feasibility, acceptability, and satisfaction of a social media intervention (Baby Dayr) for&#xD;
      low-income adolescent, first-time mothers by assessing: 1) rates of enrollment and completion&#xD;
      of daily challenges, 2) acceptability ratings of Baby Dayr; and 3) satisfaction with Baby&#xD;
      Dayr. Participants will be randomly assigned to the intervention (Baby Dayr and MIHP) (n =&#xD;
      40) or control group (MIHP care only) (n = 40). The intervention consists of six weeks of&#xD;
      daily challenges and will be delivered starting when the infant is four to six weeks old. The&#xD;
      study is innovative in its: 1) assessment of ICF to reduce rapid/excessive infant weight gain&#xD;
      in the first six months of life with low-income, adolescent, first-time mother-infant dyads,&#xD;
      and 2) combination of an infant-centered skill-building, educational, and coaching approach&#xD;
      using social media that is accessible and suitable for adolescents. The proposed research is&#xD;
      significant in that it will contribute to the science related to ICF and knowledge regarding&#xD;
      use of a social media platform in an at-risk population that can lead to reducing the risk of&#xD;
      infant obesity. Information gained from this study will be used to refine the intervention&#xD;
      for use in a larger-scale, longitudinal, randomized, controlled trial to reduce obesity risk&#xD;
      in infants of low-income, adolescent mothers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Infant Growth</measure>
    <time_frame>Baby is less than 2 months; baby is 3 months; baby is 6 months</time_frame>
    <description>Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Adolescent Mothers</condition>
  <condition>Infant Obesity</condition>
  <arm_group>
    <arm_group_label>Tools for Teen Moms Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIHP standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tools for Teen Moms</intervention_name>
    <description>The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities (&quot;challenges&quot;) for this population. The intervention consists of 6 weeks of daily challenges and will be delivered within the infant's first 6 months of life.</description>
    <arm_group_label>Tools for Teen Moms Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified, English-speaking&#xD;
&#xD;
          -  Low-income, adolescent&#xD;
&#xD;
          -  First-time mothers between the ages of 14 and 19&#xD;
&#xD;
          -  With daily web access and access to a cell phone that includes text messaging&#xD;
             capabilities&#xD;
&#xD;
          -  Family income ≤ 185% of federal poverty&#xD;
&#xD;
          -  Term birth (37≤42 weeks, 2500≤3750 grams birth weight)&#xD;
&#xD;
          -  Mothers and infants with no special nutrients or feeding needs&#xD;
&#xD;
          -  Infants less than six weeks old at study enrollment who have not started eating solid&#xD;
             foods&#xD;
&#xD;
          -  Adolescent mothers must be a primary caretaker of the infant who feeds her infant at&#xD;
             least once a day, and who is willing to participate in a six-week intervention with&#xD;
             data collection at three defined time points (T1, T2, and T3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male caregivers&#xD;
&#xD;
          -  Mothers and infants with diagnosed feeding/eating disorders&#xD;
&#xD;
          -  Significant perinatal or postnatal complications&#xD;
&#xD;
          -  Post partum depression or other mental health problems&#xD;
&#xD;
          -  Adolescent mothers who do not share in the feeding responsibility of their infants&#xD;
&#xD;
          -  Adolescents without daily web access nor a cell phone with text messaging capabilities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mildred A Horodynski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kami Silk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Horodynski MA, Silk K, Hsieh G, Hoffman A, Robson M. Tools for teen moms to reduce infant obesity: a randomized clinical trial. BMC Public Health. 2015 Jan 21;15:22. doi: 10.1186/s12889-015-1345-x.</citation>
    <PMID>25604090</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>May 30, 2017</results_first_submitted>
  <results_first_submitted_qc>March 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2019</results_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Michigan State University</investigator_affiliation>
    <investigator_full_name>Mildred Horodynski</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Infant</keyword>
  <keyword>Obesity</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Social media</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Teen mothers of infants were recruited. Teen mothers participated in the intervention. Infants were included for collection of demographic and weight data. Thus the actual number of participants is doubled to account for both the mothers and infants as participants. Protocol Enrollment number then is 164 ( 82 teen mothers and 82 infants).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tools for Teen Moms Intervention Group</title>
          <description>Tools for Teen Moms intervention group (N = 51 teen mothers) will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.&#xD;
Tools for Teen Moms: The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities (&quot;challenges&quot;) for this population.</description>
        </group>
        <group group_id="P2">
          <title>MIHP Standard Care</title>
          <description>MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant. 31 teen mothers received MIHP standard care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102">Teens were the participants who received the intervention. Data were collected on the infants.</participants>
                <participants group_id="P2" count="62">Teen participants received the MIHP standard care. Data were collected on infants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Infants</title>
              <participants_list>
                <participants group_id="P1" count="51">Infants of participants included in the study for collection of demographic and weight data.</participants>
                <participants group_id="P2" count="31">Infants of participants included in the study for collection of demographic and weight data.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Mothers</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="82">Data were collected on all of the infants of the teen moms (n = 41).</participants>
                <participants group_id="P2" count="52">Data were collected on all of the infants of teen moms (n = 26).</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="10"/>
              </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="20"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Both teen mothers and their infants were enrolled in the study. Teen mothers received the intervention and/or the standard care. Overall number of baseline participants is 164 (82 teen mothers and 82 infants). Data were collected for infants during the study. Baseline population demographics are provided for the teen mothers and infants.</population>
      <group_list>
        <group group_id="B1">
          <title>Tools for Teen Moms Intervention Group</title>
          <description>Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.</description>
        </group>
        <group group_id="B2">
          <title>MIHP Standard Care</title>
          <description>MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.</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="102"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="164"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.53" spread="1.30"/>
                    <measurement group_id="B2" value="17.61" spread="1.41"/>
                    <measurement group_id="B3" value="17.56" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>teen mother 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="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>In a Relationship</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not in a Relationship</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest level of education completed</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>6th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7th grade</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>8th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>9th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>11th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>12th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school diploma or GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completed some college credits</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment Status</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Full time (at least 35 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Working part-time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not working</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infant age at enrollment</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.21" spread="0.48"/>
                    <measurement group_id="B2" value="1.18" spread="0.54"/>
                    <measurement group_id="B3" value="1.20" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infant sex</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth weight (kg)</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.21" spread="0.40"/>
                    <measurement group_id="B2" value="3.21" spread="0.43"/>
                    <measurement group_id="B3" value="3.21" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth length (cm)</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.98" spread="2.71"/>
                    <measurement group_id="B2" value="50.70" spread="2.88"/>
                    <measurement group_id="B3" value="50.88" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infant Baseline weight (kg)</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.30" spread="0.75"/>
                    <measurement group_id="B2" value="4.27" spread="0.78"/>
                    <measurement group_id="B3" value="4.29" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infant Baseline length (cm)</title>
          <description>Data on infant participants</description>
          <population>Only infants were analyzed for this measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.75" spread="2.99"/>
                    <measurement group_id="B2" value="55.05" spread="3.61"/>
                    <measurement group_id="B3" value="54.86" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Breastfeeding status at baseline</title>
          <description>Data on teen mother participants</description>
          <population>Only mothers were analyzed for this measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Currently Breastfeeding</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Breastfed in the past</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never Breastfed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Solid feeding status at baseline</title>
          <description>Data on infant participants</description>
          <population>This data pertains only to the infants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Fed anything other than breastmilk or formula</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Given tastes of solid food from mother's finger</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</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>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Infant Growth</title>
        <description>Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.</description>
        <time_frame>Baby is less than 2 months; baby is 3 months; baby is 6 months</time_frame>
        <population>82 participants were included in analysis at Time 1, 79 at Time 2, and 67 at Time 3. This is due to participants lost to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Tools for Teen Moms Intervention Group</title>
            <description>Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.</description>
          </group>
          <group group_id="O2">
            <title>MIHP Standard Care</title>
            <description>MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Infant Growth</title>
          <description>Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.</description>
          <population>82 participants were included in analysis at Time 1, 79 at Time 2, and 67 at Time 3. This is due to participants lost to follow-up.</population>
          <units>Weight for age Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1 (infant 2-8 weeks of age)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.90"/>
                    <measurement group_id="O2" value="-0.44" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2 (infant about 3 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.95"/>
                    <measurement group_id="O2" value="-0.46" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 3 (infant about 6 months)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="1.17"/>
                    <measurement group_id="O2" value="-0.21" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tools for Teen Moms Intervention Group</title>
          <description>Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.</description>
        </group>
        <group group_id="E2">
          <title>MIHP Standard Care</title>
          <description>MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </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="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mildred A. Horodynski</name_or_title>
      <organization>Michigan State University, College of Nursing</organization>
      <phone>(517) 355-6744</phone>
      <email>millie@msu.edu; silkk@msu.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/NCT02244424
org study id: 1R21HDO75974-OIAL
nct id: NCT02244424
lead sponsor: 
has dmc: No
The purpose of this social media group randomized trial (GRT) is to test the feasibility of
      our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues
      and implement healthy feeding practices through development of a healthy feeding style.

      Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered
      to the target population as it relates to their acceptance and satisfaction with the content,
      format, delivery, and use of social media.

      Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of
      infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and
      feeding practices evaluated at the completion of the intervention using self-report methods.
Rapid weight gain during infancy is one of the strongest risk factors for obesity later in
      childhood. Weight gain in infancy is closely linked with feeding practices. Unhealthy
      mother-infant feeding practices contribute to rapid and/or excessive infant weight gain.
      Lower-income, adolescent, first-time mothers are less likely to engage in infant-centered
      feeding (ICF) which is characterized by maternal responsiveness (MR), healthy feeding styles
      (FS), and healthy feeding practices (FP). ICF is needed to reduce rapid/excessive weight gain
      during the first six months of life and to foster infant feeding self-regulation that is
      associated with healthy growth. ICF is a critical factor in reducing infant obesity risk and
      later adverse health conditions. Practical early intervention strategies are necessary to
      promote ICF among adolescent mothers to reduce obesity risk. We propose Baby Dayr, a novel
      social media intervention platform designed by the investigators which includes cell phone
      text message reminders, an infant feeding website, and Facebook to increase ICF through daily
      behavioral challenge activities ("challenges") for this population. Because cell phones
      permit natural, frequent and non-intrusive contact as they are not time-or-place-dependent,
      they offer an innovative strategy for intervening with adolescent mothers. However, this
      approach is untested for its feasibility with this population regarding infant feeding
      practices. We propose an exploratory, longitudinal, randomized, two-group study design. The
      three specific aims are: 1) to establish preliminary efficacy of the intervention as assessed
      by infant growth evaluated pre-intervention, immediately post intervention, and when the
      infant is six months old; 2) establish preliminary efficacy of the Baby Dayr plus
      Maternal-Infant Health Program (MIHP) care vs. MIHP care only on infant-centered feeding (MR,
      FS, and FP) mediated by maternal knowledge and self-efficacy; and 3) establish the
      feasibility, acceptability, and satisfaction of a social media intervention (Baby Dayr) for
      low-income adolescent, first-time mothers by assessing: 1) rates of enrollment and completion
      of daily challenges, 2) acceptability ratings of Baby Dayr; and 3) satisfaction with Baby
      Dayr. Participants will be randomly assigned to the intervention (Baby Dayr and MIHP) (n =
      40) or control group (MIHP care only) (n = 40). The intervention consists of six weeks of
      daily challenges and will be delivered starting when the infant is four to six weeks old. The
      study is innovative in its: 1) assessment of ICF to reduce rapid/excessive infant weight gain
      in the first six months of life with low-income, adolescent, first-time mother-infant dyads,
      and 2) combination of an infant-centered skill-building, educational, and coaching approach
      using social media that is accessible and suitable for adolescents. The proposed research is
      significant in that it will contribute to the science related to ICF and knowledge regarding
      use of a social media platform in an at-risk population that can lead to reducing the risk of
      infant obesity. Information gained from this study will be used to refine the intervention
      for use in a larger-scale, longitudinal, randomized, controlled trial to reduce obesity risk
      in infants of low-income, adolescent mothers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change in Infant Growth
time frame: Baby is less than 2 months; baby is 3 months; baby is 6 months
description: Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.
arm group label: Tools for Teen Moms Intervention Group
arm group type: Experimental
description: Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention.
arm group label: MIHP standard care
arm group type: No Intervention
description: MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.
intervention type: Behavioral
intervention name: Tools for Teen Moms
description: The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities ("challenges") for this population. The intervention consists of 6 weeks of daily challenges and will be delivered within the infant's first 6 months of life.
arm group label: Tools for Teen Moms Intervention Group
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
last name: Mildred A Horodynski, PhD
role: Principal Investigator
affiliation: Michigan State University
last name: Kami Silk, PhD
role: Principal Investigator
affiliation: Michigan State University
facility: 
country: United States
citation: Horodynski MA, Silk K, Hsieh G, Hoffman A, Robson M. Tools for teen moms to reduce infant obesity: a randomized clinical trial. BMC Public Health. 2015 Jan 21;15:22. doi: 10.1186/s12889-015-1345-x.
PMID: 25604090
responsible party type: Principal Investigator
investigator affiliation: Michigan State University
investigator full name: Mildred Horodynski
investigator title: Professor
mesh term: Obesity
mesh term: Pediatric Obesity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 