<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/NCT01713868</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HD072815-01</org_study_id>
    <nct_id>NCT01713868</nct_id>
  </id_info>
  <brief_title>Social Media And Risk-reduction Training for Infant Care Practices (SMART)</brief_title>
  <acronym>SMART</acronym>
  <official_title>Social Media And Risk-reduction Training for Infant Care Practices (SMART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this proposal is to address serious and ongoing challenges related to adherence&#xD;
      to public health recommendations known to reduce the risk of SIDS. Adherence has reached a&#xD;
      plateau at an unacceptably low level both in the overall US population and especially in&#xD;
      Black infants leading to a halt in the decline in infant mortality and a widening in the&#xD;
      racial disparity in infant mortality. The current proposal is a collaborative effort that&#xD;
      will capitalize on the extensive experience of the investigators in studying barriers to&#xD;
      adherence to safe sleep practices to develop two complementary, culturally competent,&#xD;
      intervention strategies and to test the effectiveness of each strategy as well as both&#xD;
      strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training&#xD;
      of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the&#xD;
      field; 2) leveraging of the currently operational infant care practices study infrastructure&#xD;
      and hospitals; 3) use of two complementary interventions with the potential for synergistic&#xD;
      impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to&#xD;
      deliver messages; and 6) collaboration with community resources and expertise. The SMART&#xD;
      study will have four arms in which 16 hospitals are randomly assigned to one of the following&#xD;
      study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2)&#xD;
      Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery&#xD;
      Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and&#xD;
      Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital),&#xD;
      with 400 in each study group. The primary aim is to assess the effectiveness of the&#xD;
      interventions aimed at promoting safe sleep practices compared with the breastfeeding control&#xD;
      interventions. The secondary aim is to assess potential mediating factors that may explain&#xD;
      the intervention effects on infant care practices and that may inform areas for future&#xD;
      improved intervention approaches. With the successful completion of the SMART study,&#xD;
      effectiveness data will have been provided for two interventions to improve adherence to safe&#xD;
      sleep practices that are practical to disseminate nationally in multiple diverse settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FOA PAR-11-242 seeks research that will improve the design, implementation, and effectiveness&#xD;
      of interventions to prevent Sudden Infant Death Syndrome (SIDS) and unintentional&#xD;
      injury-related infant deaths associated with the sleep environment. The SMART (Social Media&#xD;
      and Risk Reduction Training) Infant Care Practices proposal is a collaborative effort among&#xD;
      researchers who collectively have generated much of the data on infant care practices that&#xD;
      underlie the need for this FOA, and who have access to an already existing and operational&#xD;
      infrastructure that permits performance of a large randomized clinical trial to study&#xD;
      preventative interventions. This infrastructure was created for the NICHD-funded SAFE Infant&#xD;
      Care Practices study, for which mothers are being recruited in 2011, 2012, and 2013 at a&#xD;
      nationally-representative group of birth hospitals, with completion of infant care practice&#xD;
      surveys at 2-5 months after birth. These hospitals, which will complete their participation&#xD;
      in SAFE during 2013, are geographically and culturally diverse, will have had 3 years of&#xD;
      baseline infant care practice data collected, and have a proven track record of successful&#xD;
      recruitment. We will use our collective extensive experience studying barriers to adherence&#xD;
      to safe sleep practices to develop two complementary, culturally competent intervention&#xD;
      strategies and to test the effectiveness of each strategy, as well as both strategies in&#xD;
      combination. Both of the proposed intervention strategies, described below, were selected&#xD;
      largely because they can be used in diverse populations and offer the potential to be rapidly&#xD;
      disseminated nationwide.&#xD;
&#xD;
      Nursery Education: A nursery-based training program will be modeled after our successful&#xD;
      pilot study and informed by our collective research on barriers to adopting safe sleep&#xD;
      practices. We will use social marketing strategies to capture the attention of nursing staff&#xD;
      and empower them to improve safe sleep practice modeling and messaging received by mothers&#xD;
      and extended families during the post-partum hospital stay.&#xD;
&#xD;
      mHealth: We will use an innovative approach, using mobile messaging, that applies expertise&#xD;
      in social marketing to provide multiple short culturally competent videos delivered via email&#xD;
      from the end of the post-partum hospital stay through 2 months of age. This strategy will&#xD;
      leverage the internet as a powerful tool to access health information, and mobile devices&#xD;
      (e.g., cell phones), which have made internet access possible for many, particularly those&#xD;
      who are younger, minority, and from lower socioeconomic and educational backgrounds. Using&#xD;
      technology to deliver health-related information is likely to be a well-accepted and&#xD;
      effective strategy, particularly among minority and low-income populations. Indeed, studies&#xD;
      demonstrate that email may be an effective, inexpensive, and time-efficient strategy to&#xD;
      transmit health information.&#xD;
&#xD;
      For each of the safe sleep practice interventions (Nursery Education and mHealth), we will&#xD;
      develop control interventions in which the Nursery Education or mHealth approach is used to&#xD;
      promote breastfeeding. We have chosen breastfeeding as the control intervention because it 1)&#xD;
      is not expected to impact endpoints critical to the assessment of the safe sleep practice&#xD;
      intervention, and 2) provides health promoting messages to control mothers.&#xD;
&#xD;
      In the SMART study, we propose a 4-arm RCT in which 16 hospitals completing participation in&#xD;
      the SAFE study are randomly assigned to one of the following groups (with Safe Sleep&#xD;
      Intervention and/or Breastfeeding Control): 1) Safe Sleep Nursery Education and Breastfeeding&#xD;
      mHealth messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3)&#xD;
      Safe Sleep Nursery Education and Safe Sleep mHealth messaging; and 4) Breastfeeding Nursery&#xD;
      Education and Breastfeeding mHealth messaging. We are uniquely positioned to design,&#xD;
      implement and test the effectiveness of these interventions in a methodologically rigorous&#xD;
      way and propose the following specific aims: Primary Aim: To assess the effectiveness of the&#xD;
      interventions aimed at promoting safe sleep practices compared with the breastfeeding&#xD;
      controls.&#xD;
&#xD;
      Hypothesis:For each recommended safe sleep practice (supine sleep position, not bed sharing,&#xD;
      pacifier use, avoiding use of soft bedding), when controlling for other variables, there will&#xD;
      be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an&#xD;
      increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to&#xD;
      mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging&#xD;
      alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and&#xD;
      Safe Sleep mHealth messaging.&#xD;
&#xD;
      Secondary Aim: Assess potential mediating factors that may explain the intervention effects&#xD;
      on infant care practices and that may inform areas for future improved intervention&#xD;
      approaches.&#xD;
&#xD;
      Hypothesis: Changes in variables within each of the domains of the Theory of Planned Behavior&#xD;
      (Attitudes/Beliefs, Social Norms, Perceived Control) will be mediators of the effectiveness&#xD;
      of safe sleep interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence With Recommended Supine Sleep Position</measure>
    <time_frame>6 months</time_frame>
    <description>Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence With Recommended Roomsharing Without Bed Sharing</measure>
    <time_frame>6 months</time_frame>
    <description>Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence With Recommended Pacifier Use</measure>
    <time_frame>6 months</time_frame>
    <description>Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence With Recommended Avoiding Use of Soft Bedding</measure>
    <time_frame>6 months</time_frame>
    <description>Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep</measure>
    <time_frame>6 months</time_frame>
    <description>Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.</measure>
    <time_frame>6 months</time_frame>
    <description>Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep</measure>
    <time_frame>6 months</time_frame>
    <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.</measure>
    <time_frame>6 months</time_frame>
    <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1600</enrollment>
  <condition>Risk Reduction</condition>
  <arm_group>
    <arm_group_label>Safe Sleep Edu and Breastfeeding mHealth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breastfeeding Edu and Safe Sleep mHealth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safe Sleep Edu and Safe Sleep mHealth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breastfeed Edu and Breastfeed mHealth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safe Sleep Nursery Education</intervention_name>
    <description>Nursery-based program for safe sleep</description>
    <arm_group_label>Safe Sleep Edu and Breastfeeding mHealth</arm_group_label>
    <arm_group_label>Safe Sleep Edu and Safe Sleep mHealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breastfeeding Nursery Education</intervention_name>
    <description>Nursery-based program to promote breastfeeding</description>
    <arm_group_label>Breastfeed Edu and Breastfeed mHealth</arm_group_label>
    <arm_group_label>Breastfeeding Edu and Safe Sleep mHealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breastfeeding Mobile Health Messaging</intervention_name>
    <description>Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
    <arm_group_label>Breastfeed Edu and Breastfeed mHealth</arm_group_label>
    <arm_group_label>Safe Sleep Edu and Breastfeeding mHealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safe Sleep Mobile Health Messaging</intervention_name>
    <description>Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
    <arm_group_label>Breastfeeding Edu and Safe Sleep mHealth</arm_group_label>
    <arm_group_label>Safe Sleep Edu and Safe Sleep mHealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - mothers must live in the US, deliver a healthy infant in one of the study hospitals, plan&#xD;
        to take her baby home with her, and be able to receive emails.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - mothers who are not English speaking, whose infant is deceased, those not having custody&#xD;
        of the infant, and those whose infants require hospitalization for more than 1 week, or&#xD;
        have an ongoing medical problem requiring subspecialty care and mothers who are unable to&#xD;
        receive email messages.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Corwin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eve R Colson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fern R Hauck, M.D., M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel Moon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>November 14, 2018</results_first_submitted>
  <results_first_submitted_qc>December 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 3, 2019</results_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Rachel Moon, MD</investigator_full_name>
    <investigator_title>Rachel Moon, M.D.</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Safe Sleep</keyword>
  <keyword>Messaging</keyword>
  <keyword>Social Media</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Safe Sleep Edu and Breastfeeding mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
        <group group_id="P2">
          <title>Breastfeeding Edu and Safe Sleep mHealth</title>
          <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="P3">
          <title>Safe Sleep Edu and Safe Sleep mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="P4">
          <title>Breastfeed Edu and Breastfeed mHealth</title>
          <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="400"/>
                <participants group_id="P2" count="400"/>
                <participants group_id="P3" count="400"/>
                <participants group_id="P4" count="400"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="303"/>
                <participants group_id="P2" count="335"/>
                <participants group_id="P3" count="320"/>
                <participants group_id="P4" count="305"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="80"/>
                <participants group_id="P4" count="95"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Safe Sleep Edu and Breastfeeding mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
        <group group_id="B2">
          <title>Breastfeeding Edu and Safe Sleep mHealth</title>
          <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="B3">
          <title>Safe Sleep Edu and Safe Sleep mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="B4">
          <title>Breastfeed Edu and Breastfeed mHealth</title>
          <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
        <group group_id="B5">
          <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="400"/>
            <count group_id="B2" value="400"/>
            <count group_id="B3" value="400"/>
            <count group_id="B4" value="400"/>
            <count group_id="B5" value="1600"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <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="400"/>
                    <count group_id="B2" value="400"/>
                    <count group_id="B3" value="400"/>
                    <count group_id="B4" value="400"/>
                    <count group_id="B5" value="1600"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="368"/>
                    <measurement group_id="B2" value="386"/>
                    <measurement group_id="B3" value="358"/>
                    <measurement group_id="B4" value="379"/>
                    <measurement group_id="B5" value="1491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <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="400"/>
                    <count group_id="B2" value="400"/>
                    <count group_id="B3" value="400"/>
                    <count group_id="B4" value="400"/>
                    <count group_id="B5" value="1600"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.0" spread="5.9"/>
                    <measurement group_id="B2" value="29.3" spread="5.8"/>
                    <measurement group_id="B3" value="27.1" spread="5.9"/>
                    <measurement group_id="B4" value="27.6" spread="5.7"/>
                    <measurement group_id="B5" value="27.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Number of participants with data to analyze differed from the number of participants recruited because of attrition.</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="303"/>
                    <count group_id="B2" value="335"/>
                    <count group_id="B3" value="320"/>
                    <count group_id="B4" value="305"/>
                    <count group_id="B5" value="1263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="335"/>
                    <measurement group_id="B3" value="320"/>
                    <measurement group_id="B4" value="305"/>
                    <measurement group_id="B5" value="1263"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                    <count group_id="B2" value="400"/>
                    <count group_id="B3" value="400"/>
                    <count group_id="B4" value="400"/>
                    <count group_id="B5" value="1600"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="144"/>
                    <measurement group_id="B4" value="127"/>
                    <measurement group_id="B5" value="520"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="279"/>
                    <measurement group_id="B3" value="256"/>
                    <measurement group_id="B4" value="273"/>
                    <measurement group_id="B5" value="1080"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                    <count group_id="B2" value="400"/>
                    <count group_id="B3" value="400"/>
                    <count group_id="B4" value="400"/>
                    <count group_id="B5" value="1600"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="173"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="133"/>
                    <measurement group_id="B5" value="502"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="187"/>
                    <measurement group_id="B4" value="141"/>
                    <measurement group_id="B5" value="645"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="105"/>
                    <measurement group_id="B4" value="98"/>
                    <measurement group_id="B5" value="343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal educational level</title>
          <population>Because of attrition, number analyzed is less than number recruited.</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="303"/>
                    <count group_id="B2" value="335"/>
                    <count group_id="B3" value="320"/>
                    <count group_id="B4" value="305"/>
                    <count group_id="B5" value="1263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school or GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="88"/>
                    <measurement group_id="B5" value="312"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="104"/>
                    <measurement group_id="B5" value="438"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="101"/>
                    <measurement group_id="B5" value="420"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household income</title>
          <population>Because of attrition, number analyzed is less than number recruited</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="303"/>
                    <count group_id="B2" value="335"/>
                    <count group_id="B3" value="320"/>
                    <count group_id="B4" value="305"/>
                    <count group_id="B5" value="1263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than $20,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$20,000-49.999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$50,000 or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="91"/>
                    <measurement group_id="B4" value="88"/>
                    <measurement group_id="B5" value="435"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="108"/>
                    <measurement group_id="B5" value="408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal marital status</title>
          <population>Because of attrition, number analyzed is less than number recruited</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="303"/>
                    <count group_id="B2" value="335"/>
                    <count group_id="B3" value="320"/>
                    <count group_id="B4" value="305"/>
                    <count group_id="B5" value="1263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="147"/>
                    <measurement group_id="B4" value="163"/>
                    <measurement group_id="B5" value="640"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="151"/>
                    <measurement group_id="B4" value="132"/>
                    <measurement group_id="B5" value="552"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced, separated, or widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adherence With Recommended Supine Sleep Position</title>
        <description>Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
        <time_frame>6 months</time_frame>
        <population>Results analyzed at 2+ months infant age.</population>
        <group_list>
          <group group_id="O1">
            <title>Safe Sleep Edu and Breastfeeding mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
          <group group_id="O2">
            <title>Breastfeeding Edu and Safe Sleep mHealth</title>
            <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O3">
            <title>Safe Sleep Edu and Safe Sleep mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O4">
            <title>Breastfeed Edu and Breastfeed mHealth</title>
            <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence With Recommended Supine Sleep Position</title>
          <description>Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
          <population>Results analyzed at 2+ months infant age.</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="301"/>
                <count group_id="O2" value="333"/>
                <count group_id="O3" value="319"/>
                <count group_id="O4" value="303"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Usual supine sleep position</title>
                  <measurement_list>
                    <measurement group_id="O1" value="230"/>
                    <measurement group_id="O2" value="294"/>
                    <measurement group_id="O3" value="294"/>
                    <measurement group_id="O4" value="243"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usual nonsupine position</title>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p&lt;0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>GEE logistic regression accounted for within-hospital clustering, individual-level &amp; hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.</non_inferiority_desc>
            <p_value>0.03</p_value>
            <p_value_desc>Adjusted education effect p=0.34. Adjusted mHealth effect p&lt;0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence With Recommended Roomsharing Without Bed Sharing</title>
        <description>Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safe Sleep Edu and Breastfeeding mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
          <group group_id="O2">
            <title>Breastfeeding Edu and Safe Sleep mHealth</title>
            <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O3">
            <title>Safe Sleep Edu and Safe Sleep mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O4">
            <title>Breastfeed Edu and Breastfeed mHealth</title>
            <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence With Recommended Roomsharing Without Bed Sharing</title>
          <description>Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="328"/>
                <count group_id="O3" value="313"/>
                <count group_id="O4" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Roomsharing without bedsharing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="218"/>
                    <measurement group_id="O2" value="262"/>
                    <measurement group_id="O3" value="269"/>
                    <measurement group_id="O4" value="205"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not roomsharing without bedsharing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="44"/>
                    <measurement group_id="O4" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p&lt;0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>GEE logistic regression accounted for within-hospital clustering, individual-level &amp; hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Adjusted education effect: p=0.22. Adjusted mHealth effect p&lt;0.001. Test for interaction p=0.08.</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence With Recommended Pacifier Use</title>
        <description>Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safe Sleep Edu and Breastfeeding mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
          <group group_id="O2">
            <title>Breastfeeding Edu and Safe Sleep mHealth</title>
            <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O3">
            <title>Safe Sleep Edu and Safe Sleep mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O4">
            <title>Breastfeed Edu and Breastfeed mHealth</title>
            <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence With Recommended Pacifier Use</title>
          <description>Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
          <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="326"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Usual pacifier use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="226"/>
                    <measurement group_id="O3" value="240"/>
                    <measurement group_id="O4" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usual no pacifier use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="75"/>
                    <measurement group_id="O4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p&lt;0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>GEE logistic regression accounted for within-hospital clustering, individual-level &amp; hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Adjusted education effect p=0.07. Adjusted mHealth effect p&lt;0.001. Test for interaction p=0.54</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adherence With Recommended Avoiding Use of Soft Bedding</title>
        <description>Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safe Sleep Edu and Breastfeeding mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
          <group group_id="O2">
            <title>Breastfeeding Edu and Safe Sleep mHealth</title>
            <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O3">
            <title>Safe Sleep Edu and Safe Sleep mHealth</title>
            <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
          </group>
          <group group_id="O4">
            <title>Breastfeed Edu and Breastfeed mHealth</title>
            <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence With Recommended Avoiding Use of Soft Bedding</title>
          <description>Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="333"/>
                <count group_id="O3" value="320"/>
                <count group_id="O4" value="299"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No soft bedding use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                    <measurement group_id="O2" value="259"/>
                    <measurement group_id="O3" value="262"/>
                    <measurement group_id="O4" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Soft bedding use</title>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="74"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p&lt;0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>GEE logistic regression accounted for within-hospital clustering, individual-level &amp; hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Adjusted education effect p=0.33. Adjusted mHealth effect p&lt;0.001. Test for interaction p=0.29.</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep</title>
        <description>Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).</description>
        <time_frame>6 months</time_frame>
        <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Received mHealth breastfeeding</description>
          </group>
          <group group_id="O2">
            <title>mHealth Safe Sleep</title>
            <description>Received mHealth safe sleep</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep</title>
          <description>Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).</description>
          <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</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="608"/>
                <count group_id="O2" value="655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title># reporting positive attitudes re supine sleep</title>
                  <measurement_list>
                    <measurement group_id="O1" value="313"/>
                    <measurement group_id="O2" value="491"/>
                  </measurement_list>
                </category>
                <category>
                  <title># reporting nonpositive attitudes re supine sleep</title>
                  <measurement_list>
                    <measurement group_id="O1" value="295"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Causal mediation analysis</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.</title>
        <description>Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).</description>
        <time_frame>6 months</time_frame>
        <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Received mHealth breastfeeding</description>
          </group>
          <group group_id="O2">
            <title>mHealth Safe Sleep</title>
            <description>Received mHealth safe sleep</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.</title>
          <description>Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).</description>
          <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</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="608"/>
                <count group_id="O2" value="655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive attitude re: roomsharing w/o bedsharing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="306"/>
                    <measurement group_id="O2" value="442"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonpositive attitude re roomsharing w/o bedsharing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="302"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Causal mediation analysis</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep</title>
        <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.</description>
        <time_frame>6 months</time_frame>
        <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Received mHealth breastfeeding</description>
          </group>
          <group group_id="O2">
            <title>mHealth Safe Sleep</title>
            <description>Received mHealth safe sleep</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep</title>
          <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.</description>
          <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep</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="608"/>
                <count group_id="O2" value="655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive social norms re supine sleep</title>
                  <measurement_list>
                    <measurement group_id="O1" value="332"/>
                    <measurement group_id="O2" value="466"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonpositive social norms re supine sleep</title>
                  <measurement_list>
                    <measurement group_id="O1" value="276"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Causal mediation analysis</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.</title>
        <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors</description>
        <time_frame>6 months</time_frame>
        <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Received mHealth breastfeeding</description>
          </group>
          <group group_id="O2">
            <title>mHealth Safe Sleep</title>
            <description>Received mHealth safe sleep</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.</title>
          <description>Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors</description>
          <population>All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.</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="608"/>
                <count group_id="O2" value="655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive social norms re roomsharing w/o bedsharin</title>
                  <measurement_list>
                    <measurement group_id="O1" value="297"/>
                    <measurement group_id="O2" value="350"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonpositive norms re roomsharing w/o bedsharing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="311"/>
                    <measurement group_id="O2" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Causal mediation analysis</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Safe Sleep Edu and Breastfeeding mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
        <group group_id="E2">
          <title>Breastfeeding Edu and Safe Sleep mHealth</title>
          <description>Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="E3">
          <title>Safe Sleep Edu and Safe Sleep mHealth</title>
          <description>Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging&#xD;
Safe Sleep Nursery Education: Nursery-based program for safe sleep&#xD;
Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.</description>
        </group>
        <group group_id="E4">
          <title>Breastfeed Edu and Breastfeed mHealth</title>
          <description>Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging&#xD;
Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding&#xD;
Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="400"/>
              </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="400"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="400"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="400"/>
              </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>
    <limitations_and_caveats>There was a 21% loss to follow-up, not generalizable to non-English-speaking populations, not powered to assess adverse events, did not measure clinical outcomes (i.e., rates of sudden unexpected infant death), and the results were self-reported</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Michael Corwin, MD</name_or_title>
      <organization>Boston University</organization>
      <email>mjcorwin@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/NCT01713868
org study id: 1R01HD072815-01
nct id: NCT01713868
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The goal of this proposal is to address serious and ongoing challenges related to adherence
      to public health recommendations known to reduce the risk of SIDS. Adherence has reached a
      plateau at an unacceptably low level both in the overall US population and especially in
      Black infants leading to a halt in the decline in infant mortality and a widening in the
      racial disparity in infant mortality. The current proposal is a collaborative effort that
      will capitalize on the extensive experience of the investigators in studying barriers to
      adherence to safe sleep practices to develop two complementary, culturally competent,
      intervention strategies and to test the effectiveness of each strategy as well as both
      strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training
      of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the
      field; 2) leveraging of the currently operational infant care practices study infrastructure
      and hospitals; 3) use of two complementary interventions with the potential for synergistic
      impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to
      deliver messages; and 6) collaboration with community resources and expertise. The SMART
      study will have four arms in which 16 hospitals are randomly assigned to one of the following
      study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2)
      Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery
      Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and
      Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital),
      with 400 in each study group. The primary aim is to assess the effectiveness of the
      interventions aimed at promoting safe sleep practices compared with the breastfeeding control
      interventions. The secondary aim is to assess potential mediating factors that may explain
      the intervention effects on infant care practices and that may inform areas for future
      improved intervention approaches. With the successful completion of the SMART study,
      effectiveness data will have been provided for two interventions to improve adherence to safe
      sleep practices that are practical to disseminate nationally in multiple diverse settings.
FOA PAR-11-242 seeks research that will improve the design, implementation, and effectiveness
      of interventions to prevent Sudden Infant Death Syndrome (SIDS) and unintentional
      injury-related infant deaths associated with the sleep environment. The SMART (Social Media
      and Risk Reduction Training) Infant Care Practices proposal is a collaborative effort among
      researchers who collectively have generated much of the data on infant care practices that
      underlie the need for this FOA, and who have access to an already existing and operational
      infrastructure that permits performance of a large randomized clinical trial to study
      preventative interventions. This infrastructure was created for the NICHD-funded SAFE Infant
      Care Practices study, for which mothers are being recruited in 2011, 2012, and 2013 at a
      nationally-representative group of birth hospitals, with completion of infant care practice
      surveys at 2-5 months after birth. These hospitals, which will complete their participation
      in SAFE during 2013, are geographically and culturally diverse, will have had 3 years of
      baseline infant care practice data collected, and have a proven track record of successful
      recruitment. We will use our collective extensive experience studying barriers to adherence
      to safe sleep practices to develop two complementary, culturally competent intervention
      strategies and to test the effectiveness of each strategy, as well as both strategies in
      combination. Both of the proposed intervention strategies, described below, were selected
      largely because they can be used in diverse populations and offer the potential to be rapidly
      disseminated nationwide.

      Nursery Education: A nursery-based training program will be modeled after our successful
      pilot study and informed by our collective research on barriers to adopting safe sleep
      practices. We will use social marketing strategies to capture the attention of nursing staff
      and empower them to improve safe sleep practice modeling and messaging received by mothers
      and extended families during the post-partum hospital stay.

      mHealth: We will use an innovative approach, using mobile messaging, that applies expertise
      in social marketing to provide multiple short culturally competent videos delivered via email
      from the end of the post-partum hospital stay through 2 months of age. This strategy will
      leverage the internet as a powerful tool to access health information, and mobile devices
      (e.g., cell phones), which have made internet access possible for many, particularly those
      who are younger, minority, and from lower socioeconomic and educational backgrounds. Using
      technology to deliver health-related information is likely to be a well-accepted and
      effective strategy, particularly among minority and low-income populations. Indeed, studies
      demonstrate that email may be an effective, inexpensive, and time-efficient strategy to
      transmit health information.

      For each of the safe sleep practice interventions (Nursery Education and mHealth), we will
      develop control interventions in which the Nursery Education or mHealth approach is used to
      promote breastfeeding. We have chosen breastfeeding as the control intervention because it 1)
      is not expected to impact endpoints critical to the assessment of the safe sleep practice
      intervention, and 2) provides health promoting messages to control mothers.

      In the SMART study, we propose a 4-arm RCT in which 16 hospitals completing participation in
      the SAFE study are randomly assigned to one of the following groups (with Safe Sleep
      Intervention and/or Breastfeeding Control): 1) Safe Sleep Nursery Education and Breastfeeding
      mHealth messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3)
      Safe Sleep Nursery Education and Safe Sleep mHealth messaging; and 4) Breastfeeding Nursery
      Education and Breastfeeding mHealth messaging. We are uniquely positioned to design,
      implement and test the effectiveness of these interventions in a methodologically rigorous
      way and propose the following specific aims: Primary Aim: To assess the effectiveness of the
      interventions aimed at promoting safe sleep practices compared with the breastfeeding
      controls.

      Hypothesis:For each recommended safe sleep practice (supine sleep position, not bed sharing,
      pacifier use, avoiding use of soft bedding), when controlling for other variables, there will
      be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an
      increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to
      mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging
      alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and
      Safe Sleep mHealth messaging.

      Secondary Aim: Assess potential mediating factors that may explain the intervention effects
      on infant care practices and that may inform areas for future improved intervention
      approaches.

      Hypothesis: Changes in variables within each of the domains of the Theory of Planned Behavior
      (Attitudes/Beliefs, Social Norms, Perceived Control) will be mediators of the effectiveness
      of safe sleep interventions.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Adherence With Recommended Supine Sleep Position
time frame: 6 months
description: Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
measure: Adherence With Recommended Roomsharing Without Bed Sharing
time frame: 6 months
description: Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
measure: Adherence With Recommended Pacifier Use
time frame: 6 months
description: Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
measure: Adherence With Recommended Avoiding Use of Soft Bedding
time frame: 6 months
description: Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
measure: Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
time frame: 6 months
description: Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).
measure: Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
time frame: 6 months
description: Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).
measure: Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
time frame: 6 months
description: Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.
measure: Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
time frame: 6 months
description: Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors
arm group label: Safe Sleep Edu and Breastfeeding mHealth
arm group type: Other
description: Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging
arm group label: Breastfeeding Edu and Safe Sleep mHealth
arm group type: Other
description: Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging
arm group label: Safe Sleep Edu and Safe Sleep mHealth
arm group type: Other
description: Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging
arm group label: Breastfeed Edu and Breastfeed mHealth
arm group type: Other
description: Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging
intervention type: Behavioral
intervention name: Safe Sleep Nursery Education
description: Nursery-based program for safe sleep
arm group label: Safe Sleep Edu and Breastfeeding mHealth
arm group label: Safe Sleep Edu and Safe Sleep mHealth
intervention type: Behavioral
intervention name: Breastfeeding Nursery Education
description: Nursery-based program to promote breastfeeding
arm group label: Breastfeed Edu and Breastfeed mHealth
arm group label: Breastfeeding Edu and Safe Sleep mHealth
intervention type: Behavioral
intervention name: Breastfeeding Mobile Health Messaging
description: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
arm group label: Breastfeed Edu and Breastfeed mHealth
arm group label: Safe Sleep Edu and Breastfeeding mHealth
intervention type: Behavioral
intervention name: Safe Sleep Mobile Health Messaging
description: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
arm group label: Breastfeeding Edu and Safe Sleep mHealth
arm group label: Safe Sleep Edu and Safe Sleep mHealth
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Corwin, MD
role: Principal Investigator
affiliation: Boston University
last name: Eve R Colson, M.D.
role: Principal Investigator
affiliation: Yale University
last name: Fern R Hauck, M.D., M.S.
role: Principal Investigator
affiliation: University of Virginia
last name: Rachel Moon, MD
role: Principal Investigator
affiliation: University of Virginia
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Rachel Moon, MD
investigator title: Rachel Moon, M.D.
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There was a 21% loss to follow-up, not generalizable to non-English-speaking populations, not powered to assess adverse events, did not measure clinical outcomes (i.e., rates of sudden unexpected infant death), and the results were self-reported
point of contact: 