<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/NCT04476940</url>
  </required_header>
  <id_info>
    <org_study_id>330875</org_study_id>
    <nct_id>NCT04476940</nct_id>
  </id_info>
  <brief_title>COVID-19 Breastfeeding Guideline for African-Americans</brief_title>
  <acronym>COVID-BF</acronym>
  <official_title>An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meharry Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meharry Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Newborns and infants receive passive natural immunity through maternal antibodies present in&#xD;
      breastmilk to fight infections caused by viruses such as the COVID-19, until they develop&#xD;
      active immunity by illness or vaccination. Such immunity will become the main stay for&#xD;
      preventing future waves of COVID-19 epidemics. The high COVID-19 mortality among African&#xD;
      Americans is ascribed partly to compromised immune status associated with comorbidity.&#xD;
      Exclusive breastfeeding (EBF) is the effective low-cost natural strategy for building&#xD;
      immunity right from birth. African Americans record the lowest EBF rates and also lack&#xD;
      workplace support. This intervention includes a 10-hour course extracted from 90-hour CLC&#xD;
      online program, sufficient to prepare physicians to partner with certified lactation&#xD;
      consultant (CLC) to provide their patients comprehensive COVID-19 breastfeeding guidelines,&#xD;
      training, and support to afford their babies the benefits of breastmilk antibodies, the best&#xD;
      line of defense against COVID-19, until availability of safe vaccines. The Breastfeeding&#xD;
      Report Card indicates slow improvements in overall breastfeeding rates with persisting&#xD;
      disparities. Improving EBF rates can contribute to increased COVID-19 immunity among infants.&#xD;
      Preliminary data in Nashville indicates excellent breastfeeding benefit knowledge and intent,&#xD;
      but limited training to succeed. Hospital staff encourage breastfeeding but routinely offer&#xD;
      formula at birth. Most physicians who provide prenatal care do not actively promote&#xD;
      breastfeeding nor routinely offer CLC referral. This single action by physicians can halt&#xD;
      routines that compromise successful EBF. The program long-term goal is to prepare&#xD;
      obstetricians to actively promote comprehensive breastfeeding among African American mothers.&#xD;
      The immediate objective is to develop and evaluate feasibility and effectiveness of an&#xD;
      intervention designed to increase COVID-19 breastfeeding guideline adherence and improve EBF&#xD;
      skills and rates among African American mothers. The rationale is that mothers who receive&#xD;
      physician prenatal encouragement and CLC referral will make confident informed decisions,&#xD;
      adopt COVID-19 breastfeeding guidelines, safely meet their EBF goals, and provide their&#xD;
      infants with appropriate antibodies. The expected outcome is that patient participants will&#xD;
      adhere to COVID-19 breastfeeding guidelines and record 3-month EBF rate 60 percent or&#xD;
      greater.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1: COVID-19 Breastfeeding Guideline Assessment Survey. 40 mothers who delivered during&#xD;
      the period starting from January 1, 2020 to date will be recruited and consented to assess&#xD;
      their exclusive breastfeeding (EBF) and COVID-19 breastfeeding patterns using a survey&#xD;
      designed to be completed by interview on Zoom, phone, or any other social-distancing&#xD;
      platform. Information to be collected in this survey will include: demography, medical&#xD;
      history, COVID-19 status; COVID-19 breastfeeding guideline action; Stay-home pattern;&#xD;
      Breastfeeding frequency and duration; Breastmilk expression frequency/duration; Frequency and&#xD;
      volume of feeds with expressed breastmilk or formula.&#xD;
&#xD;
      Phase 2: Intervention Development:&#xD;
&#xD;
      Participating physicians will attend two 2-hour Zoom sessions, a 4-Module Online&#xD;
      Breastfeeding Course, and a 1-hour orientation Zoom session in groups of not more than ten.&#xD;
      The following presentations, course, surveys, other materials to be developed:&#xD;
&#xD;
        1. . Three presentations: i). Introduction: Healthy People 2020 Breastfeeding Objectives,&#xD;
           Tennessee breastfeeding statistics, Breastfeeding role of physicians, nurses, and&#xD;
           certified lactation consultants (CLC). ii). Breastfeeding Challenges Faced by Mothers.&#xD;
           iii). Obstetrician Breastfeeding Promotion Challenges.&#xD;
&#xD;
        2. . Online Breastfeeding Promotion 101: A 10-hour course to be developed in partnership&#xD;
           with Breastfeeding OUTLOOK, an online continuing education provider.&#xD;
&#xD;
        3. . Research Tools: COVID-19 Breastfeeding Guideline Assessment surveys; Pre- and&#xD;
           Post-Intervention surveys for physicians; Pre- and Post-Intervention surveys for&#xD;
           patients; Consent forms for physicians; Consent and HIPAA forms for patients;&#xD;
           Recruitment flyer and Breastfeeding brochure for patients.&#xD;
&#xD;
        4. . Moderator Script for Community Engagement to guide the community-patient-provider&#xD;
           stakeholder community advisory board (CAB) discussion sessions to review and make&#xD;
           recommendations for revision to the following: intervention program, consent forms,&#xD;
           surveys, brochure, COVID-19 related guidelines for pregnant and lactating mothers, and&#xD;
           strategies to enhance participation. The 12-Person CAB of 4 mothers, 2 nurses/midwives,&#xD;
           2 CLCs, 2 physicians, a virologist, and a community leader. Investigator obstetrician&#xD;
           Ladson, G. will be the moderator and the CAB recorder will be investigator Britt, A.&#xD;
&#xD;
      Phase 3: Program Implementation Feasibility and Evaluation:&#xD;
&#xD;
      20 Obstetricians/Physicians will be consented and enrolled to participate as program&#xD;
      providers, and expected to complete the following 5 tasks:&#xD;
&#xD;
        1. . Pre-Intervention Survey: This is 15-minute self-administered pre-test survey to&#xD;
           capture breastfeeding promotion knowledge and practices, and COVID-19, other disease,&#xD;
           and drug related breastfeeding guidelines.&#xD;
&#xD;
        2. . First In-Person Session: 2-hour Zoom session in groups of not more than 10&#xD;
           participants to disseminate Program introduction (20 minutes); Breastfeeding challenges&#xD;
           faced by mothers (40 minutes); Obstetrician breastfeeding promotion challenges (40&#xD;
           minutes); Closing session (20 minutes) for Concerns, Q &amp; A.&#xD;
&#xD;
        3. . Online Breastfeeding Course 101: Participant physicians will enroll in Breastfeeding&#xD;
           OUTLOOK and complete a 10-hour module over a two-week period.&#xD;
&#xD;
        4. . Second In-Person Session: 2-hour Zoom session in groups of 10 to provide intervention&#xD;
           guidelines, research strategies and skills for participant recruitment, consenting, and&#xD;
           survey administration by interview.&#xD;
&#xD;
        5. . Intervention Implementation: 20 physicians will each be expected to recruit 10 study&#xD;
           participants in the third trimester of pregnancy from their prenatal clients over a&#xD;
           period of two months. Physicians will complete a pre-intervention survey at enrollment&#xD;
           and post-intervention survey 8 months after enrollment in the program. The physicians&#xD;
           will receive intervention protocol, patient HIPPA &amp; consent forms, flyers, and survey&#xD;
           booklet after signed consent received by email, and attend a one-hour program&#xD;
           orientation in company of an office staff and/or resident physician scheduled in groups&#xD;
           of four. The 200 study participants will sign informed consent, complete a&#xD;
           pre-intervention patient survey, continue prenatal care, and will be followed up at&#xD;
           1-month and at 3-months postpartum to complete the post-intervention patient survey.&#xD;
&#xD;
      Study Questionnaires. i) Mother COVID-19 Breastfeeding Guideline Assessment Survey:&#xD;
      Demography, medical history, items from Centers for Disease Prevention and Control (CDC) &amp;&#xD;
      Baby-Friendly Hospital Initiative (BFHI) breastfeeding surveys, EBF pattern since January 1,&#xD;
      2020, COVID-19 guideline items, COVID-19 status, Stay-home history.&#xD;
&#xD;
      ii) Physician pre-intervention survey: Monthly prenatal volume, breastfeeding knowledge, and&#xD;
      practices, CLC referral pattern, COVID-19 and other disease specific EBF guidelines.&#xD;
&#xD;
      iii) Physician post-intervention survey: Breastfeeding knowledge and practices, COVID-19 and&#xD;
      other disease specific EBF guidelines. Number of participants enrolled and number of CLC&#xD;
      referrals.&#xD;
&#xD;
      iv) Patient pre-intervention survey: Demography, medical history, CDC &amp; BFHI breastfeeding&#xD;
      survey items, physician interaction items, previous CLC encounter, COVID-19 guideline items,&#xD;
      COVID-19 status, Stay-home history.&#xD;
&#xD;
      v) Patient post-intervention survey: CLC referral, CLC appointment and breastfeeding class&#xD;
      attendance; COVID-19 guideline adherence; EBF initiation, frequency/duration of EBF;&#xD;
      frequency and duration of breastmilk expression (manual or pump); frequency and volume of&#xD;
      formula or breastmilk feeds. Infant feeding and growth pattern from medical records and&#xD;
      growth charts. COVID-19 serology test (optional).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-Test Post-test</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 breastfeeding guidance adherence at birth.</measure>
    <time_frame>At birth.</time_frame>
    <description>Percentage of participants who recorded an adherence score of 4 and above during the first week of birth.&#xD;
Range: 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 breastfeeding guidance adherence at 1-month postpartum.</measure>
    <time_frame>At 1-month postpartum.</time_frame>
    <description>Percentage of participants who recorded an adherence score of 4 and above at 1-month postpartum.&#xD;
Range: 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 breastfeeding guidance adherence at 3-months postpartum.</measure>
    <time_frame>At 3-months postpartum.</time_frame>
    <description>Percentage of participants who recorded an adherence score of 4 and above at 3-months postpartum.&#xD;
Range: 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exclusive breastfeeding at birth.</measure>
    <time_frame>At birth.</time_frame>
    <description>Percentage of participants who exclusively breastfed at birth. Range: 0 - 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exclusive breastfeeding at 1-month.</measure>
    <time_frame>At 1-month.</time_frame>
    <description>Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exclusive breastfeeding at 3-months.</measure>
    <time_frame>At 3-months.</time_frame>
    <description>Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID_Status</measure>
    <time_frame>3-months postpartum</time_frame>
    <description>Infant COVID-19 test: Positive or Negative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Immunoglobulin G</measure>
    <time_frame>3-months postpartum</time_frame>
    <description>Infant COVID-19 Immunoglobulin G serology test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Immunoglobulin M</measure>
    <time_frame>3-months postpartum</time_frame>
    <description>Infant COVID-19 Immunoglobulin M serology test result.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Certified Lactation Consult in pregnancy.</measure>
    <time_frame>At Birth.</time_frame>
    <description>Percentage of patients who consulted a Certified Lactation Consultant before delivery.&#xD;
Range: 0 - 100</description>
  </other_outcome>
  <other_outcome>
    <measure>Certified Lactation Consult after delivery.</measure>
    <time_frame>At 1-month postpartum.</time_frame>
    <description>Percentage of patients who consulted a Certified Lactation Consultant up to 1-month postpartum.&#xD;
Range: 0 - 100</description>
  </other_outcome>
  <other_outcome>
    <measure>COVID-19 breastfeeding guideline knowledge score change.</measure>
    <time_frame>1-month postpartum</time_frame>
    <description>Change in pre- and post-intervention COVID-19 breastfeeding guideline knowledge score stratified to &quot;Low&quot; &amp; &quot;High&quot;.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Covid19</condition>
  <condition>Exclusive Breastfeeding</condition>
  <arm_group>
    <arm_group_label>COVID BF-Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COVID-19 breastfeeding guideline education and support for pregnant women.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COVID-19 Breastfeeding Support</intervention_name>
    <description>Intervention will be implemented by trained prenatal care providers to provide comprehensive exclusive breastfeeding and COVID-19 breastfeeding guideline education and support to study participants.</description>
    <arm_group_label>COVID BF-Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Assessment Survey: Mothers who had a baby in 2020.&#xD;
&#xD;
          -  Intervention Participants: Women in late 2nd or 3rd pregnancy trimester enrolled for&#xD;
             prenatal care by participating physicians.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Assessment Survey: Mothers who had a baby prior to 2020.&#xD;
&#xD;
          -  Intervention Participants: Not pregnant, in 1st trimester of pregnancy, not enrolled&#xD;
             for prenatal care by participating physician.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel E Adunyah, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Meharry Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlton Z Adams, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Meharry Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Flora A Ukoli, M.D., MPH.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meharry Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Flora A Ukoli, M.D., MPH.</last_name>
    <phone>615-327-5653</phone>
    <email>fukoli@mmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Allysceaeioun D Britt, Ph.D., MPH.</last_name>
    <phone>615-327-6457</phone>
    <email>abritt@mmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meharry Medical College</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37208</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Flora A Ukoli, M.D., MPH.</last_name>
      <phone>615-327-5653</phone>
      <email>fukoli@mmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jacinat Leavell, Ph.D., MS</last_name>
      <phone>615-327-6885</phone>
      <email>jleavell@mmc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Gwinett Ladson, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kimberley Wyche-Etheridge, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tao Lu, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Exclusive Breastfeeding</keyword>
  <keyword>Breastfeeding Guidelines</keyword>
  <keyword>African American</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04476940
org study id: 330875
nct id: NCT04476940
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Newborns and infants receive passive natural immunity through maternal antibodies present in
      breastmilk to fight infections caused by viruses such as the COVID-19, until they develop
      active immunity by illness or vaccination. Such immunity will become the main stay for
      preventing future waves of COVID-19 epidemics. The high COVID-19 mortality among African
      Americans is ascribed partly to compromised immune status associated with comorbidity.
      Exclusive breastfeeding (EBF) is the effective low-cost natural strategy for building
      immunity right from birth. African Americans record the lowest EBF rates and also lack
      workplace support. This intervention includes a 10-hour course extracted from 90-hour CLC
      online program, sufficient to prepare physicians to partner with certified lactation
      consultant (CLC) to provide their patients comprehensive COVID-19 breastfeeding guidelines,
      training, and support to afford their babies the benefits of breastmilk antibodies, the best
      line of defense against COVID-19, until availability of safe vaccines. The Breastfeeding
      Report Card indicates slow improvements in overall breastfeeding rates with persisting
      disparities. Improving EBF rates can contribute to increased COVID-19 immunity among infants.
      Preliminary data in Nashville indicates excellent breastfeeding benefit knowledge and intent,
      but limited training to succeed. Hospital staff encourage breastfeeding but routinely offer
      formula at birth. Most physicians who provide prenatal care do not actively promote
      breastfeeding nor routinely offer CLC referral. This single action by physicians can halt
      routines that compromise successful EBF. The program long-term goal is to prepare
      obstetricians to actively promote comprehensive breastfeeding among African American mothers.
      The immediate objective is to develop and evaluate feasibility and effectiveness of an
      intervention designed to increase COVID-19 breastfeeding guideline adherence and improve EBF
      skills and rates among African American mothers. The rationale is that mothers who receive
      physician prenatal encouragement and CLC referral will make confident informed decisions,
      adopt COVID-19 breastfeeding guidelines, safely meet their EBF goals, and provide their
      infants with appropriate antibodies. The expected outcome is that patient participants will
      adhere to COVID-19 breastfeeding guidelines and record 3-month EBF rate 60 percent or
      greater.
Phase 1: COVID-19 Breastfeeding Guideline Assessment Survey. 40 mothers who delivered during
      the period starting from January 1, 2020 to date will be recruited and consented to assess
      their exclusive breastfeeding (EBF) and COVID-19 breastfeeding patterns using a survey
      designed to be completed by interview on Zoom, phone, or any other social-distancing
      platform. Information to be collected in this survey will include: demography, medical
      history, COVID-19 status; COVID-19 breastfeeding guideline action; Stay-home pattern;
      Breastfeeding frequency and duration; Breastmilk expression frequency/duration; Frequency and
      volume of feeds with expressed breastmilk or formula.

      Phase 2: Intervention Development:

      Participating physicians will attend two 2-hour Zoom sessions, a 4-Module Online
      Breastfeeding Course, and a 1-hour orientation Zoom session in groups of not more than ten.
      The following presentations, course, surveys, other materials to be developed:

        1. . Three presentations: i). Introduction: Healthy People 2020 Breastfeeding Objectives,
           Tennessee breastfeeding statistics, Breastfeeding role of physicians, nurses, and
           certified lactation consultants (CLC). ii). Breastfeeding Challenges Faced by Mothers.
           iii). Obstetrician Breastfeeding Promotion Challenges.

        2. . Online Breastfeeding Promotion 101: A 10-hour course to be developed in partnership
           with Breastfeeding OUTLOOK, an online continuing education provider.

        3. . Research Tools: COVID-19 Breastfeeding Guideline Assessment surveys; Pre- and
           Post-Intervention surveys for physicians; Pre- and Post-Intervention surveys for
           patients; Consent forms for physicians; Consent and HIPAA forms for patients;
           Recruitment flyer and Breastfeeding brochure for patients.

        4. . Moderator Script for Community Engagement to guide the community-patient-provider
           stakeholder community advisory board (CAB) discussion sessions to review and make
           recommendations for revision to the following: intervention program, consent forms,
           surveys, brochure, COVID-19 related guidelines for pregnant and lactating mothers, and
           strategies to enhance participation. The 12-Person CAB of 4 mothers, 2 nurses/midwives,
           2 CLCs, 2 physicians, a virologist, and a community leader. Investigator obstetrician
           Ladson, G. will be the moderator and the CAB recorder will be investigator Britt, A.

      Phase 3: Program Implementation Feasibility and Evaluation:

      20 Obstetricians/Physicians will be consented and enrolled to participate as program
      providers, and expected to complete the following 5 tasks:

        1. . Pre-Intervention Survey: This is 15-minute self-administered pre-test survey to
           capture breastfeeding promotion knowledge and practices, and COVID-19, other disease,
           and drug related breastfeeding guidelines.

        2. . First In-Person Session: 2-hour Zoom session in groups of not more than 10
           participants to disseminate Program introduction (20 minutes); Breastfeeding challenges
           faced by mothers (40 minutes); Obstetrician breastfeeding promotion challenges (40
           minutes); Closing session (20 minutes) for Concerns, Q & A.

        3. . Online Breastfeeding Course 101: Participant physicians will enroll in Breastfeeding
           OUTLOOK and complete a 10-hour module over a two-week period.

        4. . Second In-Person Session: 2-hour Zoom session in groups of 10 to provide intervention
           guidelines, research strategies and skills for participant recruitment, consenting, and
           survey administration by interview.

        5. . Intervention Implementation: 20 physicians will each be expected to recruit 10 study
           participants in the third trimester of pregnancy from their prenatal clients over a
           period of two months. Physicians will complete a pre-intervention survey at enrollment
           and post-intervention survey 8 months after enrollment in the program. The physicians
           will receive intervention protocol, patient HIPPA & consent forms, flyers, and survey
           booklet after signed consent received by email, and attend a one-hour program
           orientation in company of an office staff and/or resident physician scheduled in groups
           of four. The 200 study participants will sign informed consent, complete a
           pre-intervention patient survey, continue prenatal care, and will be followed up at
           1-month and at 3-months postpartum to complete the post-intervention patient survey.

      Study Questionnaires. i) Mother COVID-19 Breastfeeding Guideline Assessment Survey:
      Demography, medical history, items from Centers for Disease Prevention and Control (CDC) &
      Baby-Friendly Hospital Initiative (BFHI) breastfeeding surveys, EBF pattern since January 1,
      2020, COVID-19 guideline items, COVID-19 status, Stay-home history.

      ii) Physician pre-intervention survey: Monthly prenatal volume, breastfeeding knowledge, and
      practices, CLC referral pattern, COVID-19 and other disease specific EBF guidelines.

      iii) Physician post-intervention survey: Breastfeeding knowledge and practices, COVID-19 and
      other disease specific EBF guidelines. Number of participants enrolled and number of CLC
      referrals.

      iv) Patient pre-intervention survey: Demography, medical history, CDC & BFHI breastfeeding
      survey items, physician interaction items, previous CLC encounter, COVID-19 guideline items,
      COVID-19 status, Stay-home history.

      v) Patient post-intervention survey: CLC referral, CLC appointment and breastfeeding class
      attendance; COVID-19 guideline adherence; EBF initiation, frequency/duration of EBF;
      frequency and duration of breastmilk expression (manual or pump); frequency and volume of
      formula or breastmilk feeds. Infant feeding and growth pattern from medical records and
      growth charts. COVID-19 serology test (optional).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-Test Post-test
primary purpose: Prevention
masking: None (Open Label)
measure: COVID-19 breastfeeding guidance adherence at birth.
time frame: At birth.
description: Percentage of participants who recorded an adherence score of 4 and above during the first week of birth.
Range: 0 to 100.
measure: COVID-19 breastfeeding guidance adherence at 1-month postpartum.
time frame: At 1-month postpartum.
description: Percentage of participants who recorded an adherence score of 4 and above at 1-month postpartum.
Range: 0 to 100.
measure: COVID-19 breastfeeding guidance adherence at 3-months postpartum.
time frame: At 3-months postpartum.
description: Percentage of participants who recorded an adherence score of 4 and above at 3-months postpartum.
Range: 0 to 100.
measure: Exclusive breastfeeding at birth.
time frame: At birth.
description: Percentage of participants who exclusively breastfed at birth. Range: 0 - 100.
measure: Exclusive breastfeeding at 1-month.
time frame: At 1-month.
description: Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100.
measure: Exclusive breastfeeding at 3-months.
time frame: At 3-months.
description: Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100.
measure: COVID_Status
time frame: 3-months postpartum
description: Infant COVID-19 test: Positive or Negative
measure: COVID-19 Immunoglobulin G
time frame: 3-months postpartum
description: Infant COVID-19 Immunoglobulin G serology test result.
measure: COVID-19 Immunoglobulin M
time frame: 3-months postpartum
description: Infant COVID-19 Immunoglobulin M serology test result.
measure: Certified Lactation Consult in pregnancy.
time frame: At Birth.
description: Percentage of patients who consulted a Certified Lactation Consultant before delivery.
Range: 0 - 100
measure: Certified Lactation Consult after delivery.
time frame: At 1-month postpartum.
description: Percentage of patients who consulted a Certified Lactation Consultant up to 1-month postpartum.
Range: 0 - 100
measure: COVID-19 breastfeeding guideline knowledge score change.
time frame: 1-month postpartum
description: Change in pre- and post-intervention COVID-19 breastfeeding guideline knowledge score stratified to "Low" & "High".
arm group label: COVID BF-Support
arm group type: Experimental
description: COVID-19 breastfeeding guideline education and support for pregnant women.
intervention type: Behavioral
intervention name: COVID-19 Breastfeeding Support
description: Intervention will be implemented by trained prenatal care providers to provide comprehensive exclusive breastfeeding and COVID-19 breastfeeding guideline education and support to study participants.
arm group label: COVID BF-Support
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samuel E Adunyah, Ph.D.
role: Study Director
affiliation: Meharry Medical College
last name: Carlton Z Adams, M.D.
role: Study Chair
affiliation: Meharry Medical College
last name: Flora A Ukoli, M.D., MPH.
role: Principal Investigator
affiliation: Meharry Medical College
last name: Flora A Ukoli, M.D., MPH.
phone: 615-327-5653
email: fukoli@mmc.edu
last name: Allysceaeioun D Britt, Ph.D., MPH.
phone: 615-327-6457
email: abritt@mmc.edu
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19