Official Title
An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers
Brief Summary

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.

Detailed Description

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).

Unknown status
COVID19
Exclusive Breastfeeding

Behavioral: COVID-19 Breastfeeding Support

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.

Eligibility Criteria

Inclusion Criteria:

- Assessment Survey: Mothers who had a baby in 2020.

- Intervention Participants: Women in late 2nd or 3rd pregnancy trimester enrolled for
prenatal care by participating physicians.

Exclusion Criteria:

- Assessment Survey: Mothers who had a baby prior to 2020.

- Intervention Participants: Not pregnant, in 1st trimester of pregnancy, not enrolled
for prenatal care by participating physician.

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 45 Years
Countries
United States
Locations

Meharry Medical College
Nashville, Tennessee, United States

Investigator: Flora A Ukoli, M.D., MPH.
Contact: 615-327-5653
fukoli@mmc.edu

Investigator:

Contacts

Flora A Ukoli, M.D., MPH.
615-327-5653
fukoli@mmc.edu

Allysceaeioun D Britt, Ph.D., MPH.
615-327-6457
abritt@mmc.edu

Meharry Medical College
NCT Number
Keywords
Covid-19
Exclusive Breastfeeding
Breastfeeding Guidelines
African American
MeSH Terms
COVID-19