An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Meharry Medical College
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Exclusive breastfeeding at 1-month.
Study Overview
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:
- . 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.
- . Online Breastfeeding Promotion 101: A 10-hour course to be developed in partnership with Breastfeeding OUTLOOK, an online continuing education provider.
- . 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.
- . 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Assessment Survey: Mothers who had a baby in
- •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
- •Intervention Participants: Not pregnant, in 1st trimester of pregnancy, not enrolled for prenatal care by participating physician.
Outcomes
Primary Outcomes
Exclusive breastfeeding at 1-month.
Time Frame: At 1-month.
Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100.
COVID-19 breastfeeding guidance adherence at 1-month postpartum.
Time Frame: At 1-month postpartum.
Percentage of participants who recorded an adherence score of 4 and above at 1-month postpartum. Range: 0 to 100.
COVID-19 breastfeeding guidance adherence at birth.
Time Frame: At birth.
Percentage of participants who recorded an adherence score of 4 and above during the first week of birth. Range: 0 to 100.
Exclusive breastfeeding at birth.
Time Frame: At birth.
Percentage of participants who exclusively breastfed at birth. Range: 0 - 100.
COVID-19 breastfeeding guidance adherence at 3-months postpartum.
Time Frame: At 3-months postpartum.
Percentage of participants who recorded an adherence score of 4 and above at 3-months postpartum. Range: 0 to 100.
Exclusive breastfeeding at 3-months.
Time Frame: At 3-months.
Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100.
Secondary Outcomes
- COVID_Status(3-months postpartum)
- COVID-19 Immunoglobulin M(3-months postpartum)
- COVID-19 Immunoglobulin G(3-months postpartum)