Abstract
Background:
Breastfeeding is a key public health priority with known racial inequities. Despite the well-described and far-reaching health benefits of breastfeeding for mothers and infants, rates of breastfeeding initiation, continuation, and exclusivity lag meaningfully among African American and Black (AA/B) women compared with other racial and ethnic groups due in main to current and historical structural racism.
Methods:
The study objective was to assess the replicability of Breast for Success (BFS) on breastfeeding rates among home-visited low-income predominantly AA/B mothers. The BFS Excels a Second Time (BEST) trial was an observational study conducted at the Neighborhood Health Association, Toledo, OH, enrolling expectant women (June 2022–March 2023, followed to October 2023) participating in the Moms and Babies First (MBF) Community Health Worker (CHW)-led home visiting program. The exposure, BFS, includes 11 CHW-delivered breastfeeding-supportive modules, breastfeeding supplies, and a postnatal lactation visit. All MBF mothers received BFS; those who agreed to data sharing were BEST participants. The outcomes were breastfeeding initiation, and breastfeeding continuation, and exclusivity at 1 month.
Results:
The majority of participants were AA/B (48, 83%), had an income <200% poverty level (55, 95%), and were unmarried (57, 98%); mean age was 25.8 years (SD 5.5). Of the 58 participants, 57 (98%) initiated breastfeeding and continued breastfeeding at 1 month postpartum; 53 (91%) were exclusively breastfeeding at 1 month postpartum.
Discussion:
BFS piggybacks seamlessly onto CHW-led home-visiting curricula and increased breastfeeding rates among women at high risk for not breastfeeding. Public health programs can add BFS to fill a critical curricular and impact gap with respect to breastfeeding support.
Introduction
Exclusive breastfeeding through 6 months is recommended by professional bodies worldwide, with profound health benefits, including reduced risk of gastrointestinal and respiratory infections, sudden infant death syndrome and overall mortality among infants, and reduced risk of breast and ovarian cancer and cardiovascular disease for mothers.1,2 However, this key public health goal remains elusive, with widespread racial inequities due in main to current and historical structural racism. 3 Nationally 84.1% of all mothers but just 75.4% of African American or Black (AA/B) mothers initiate breastfeeding; 27.2% of all mothers but just 24.4% of AA/B mothers are exclusively breastfeeding at 6 months postpartum as recommended (2021). 3 The state of Ohio faces similar inequities, and in specific counties targeted by the Ohio Equity Institute (Ohio Department of Health, Bureau of Maternal Child and Family Health) for improvement in birth outcomes, including the study site, 64.6% of all mothers, but just 55.9% of AA/B mothers continue breastfeeding at 8 weeks postpartum.4,5
In previous work, we demonstrated that a modular breastfeeding curriculum, called Breast for Success (BFS), piggy-backed onto home visiting by Community Health Workers (CHWs) as part of a comprehensive pregnancy and postpartum program to support equitable birth outcomes among high risk predominantly AA/B women, was successful in increasing rates of continuing breastfeeding at 1 month postpartum.6,7 BFS is a comprehensive intervention designed to tackle structural racism as a leading barrier to breastfeeding for AA/B women and their families. The BEST (Breast for Success Excels a Second Time) study aim was to demonstrate that BFS is associated with increasing rates of breastfeeding initiation and continuation at 1 month when added to a CHW-led home-visiting curriculum in a different geographical region and different local program setting. The overarching study aim was to effectively address racial disparities in breastfeeding outcomes by continuing to serve AA/B women at high risk for not breastfeeding.
Materials and Methods
Study design
The BEST trial was a prospective non-blinded non-randomized single cohort study.
Population and setting
We conducted this work under the auspices of the “Moms and Babies First” (MBF) program, run by the Neighborhood Health Association, Toledo, Lucas County, OH, and funded by the Ohio Department of Health. Lucas County is one of 10 Ohio Equity Institute Counties (of 88 counties in Ohio), defined as having the greatest racial disparities with respect to poor birth outcomes and infant mortality. MBF serves predominantly AA/B women, all of whom are expectant and whose income is <200% of the federal poverty level. All MBF mothers received the BFS intervention and were research-eligible; those who consented to de-identified sharing of their information were enrolled in the BEST trial.
Recruitment and enrollment
The study was approved by the Institutional Review Boards of University Hospitals Cleveland Medical Center and the Ohio Department of Health. Informed consent was obtained from all participants. MBF CHWs comprised the research team and enrolled interested mothers in BEST at entry to MBF.
Training and logistics
MBF CHWs engaged in a 1 hour long virtual training session that included (1) BFS content, procedures and rationale, (2) BEST study enrollment, consenting and data collection, and (3) breastfeeding basics, breastfeeding resources, and measurement for nursing bras. Breastfeeding supplies were purchased via commercial vendors. Nursing bras were procured through Bravado Bras (https://bravadodesigns.com) Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) catalog. The BFS modules are available online and are free with acknowledgment. 6 The total approximate cost per mother for BFS (supplies included three nursing bras, one tube of lanolin, and 200 disposable breastfeeding pads) was $60. A WIC breastfeeding peer helper conducted scheduled postpartum lactation visits, which dovetailed with her employment responsibilities.
BFS description
The BFS curriculum is an interactive guide that supports the home-visiting CHW in providing culturally attuned, meaningful, and informed lactation care. The module component includes 4 sections with 9 prenatal and 2 postnatal modules. Section 1, “Can breastfeeding work for me?” has 4 modules: “What’s so great about breastfeeding?” (benefits of breastfeeding for infant and mother), “What about my life?” (FAQs for life and work questions), “Glad you asked!” (questions and responses for informed infant feeding choice), and “Care of me” (True/false for “urban myths” about breastfeeding with explanation). Section 2, “Who will support me while breastfeeding?” has 2 modules: “Dads/partners are needed for breastfeeding” (ways to include the father/partner in breastfeeding) and “How can we work this out together?” (interactive questions and prompts for a facilitated discussion with mom and her partner). Section 3, “Let’s get started breastfeeding” has 3 modules: “All about Latch-say no to pain” (latch information and video), a 3–4 day postpartum breastfeeding checklist to assess breastfeeding with a resource list, and “Is my baby getting enough - how to make milk (ways to increase supply). Section 4, “Hang in there – It’s only temporary” has 2 modules: “Do the first two weeks last forever?” (common problems and solutions for the first two weeks in question-and-answer format) and “Am I stuck here or is it bonding?” (interactive prompts and responses for a discussion on postpartum feelings). BFS includes breastfeeding supplies, specifically at least 2–3 quality breastfeeding bras, disposable nursing pads, and lanolin; mothers are measured for their bras at 36 weeks gestation by CHWs (accounting for expected changes in cup size with lactation onset) and all supplies are home-delivered. Additionally, a community-based lay lactation provider makes contact with the mother prior to her delivery and schedules and then conducts a 3–5 day postpartum lactation visit, overcoming the barriers of scheduling, transportation, and availability usually associated with needed early post-hospital discharge lactation care. BFS development—All intervention development was shared by community partners, the lead academic author, and members of the community of interest. The process of program development began with monthly open coalition meetings including lay and professional stakeholders over a period of a year (March 2009– March 2010). A three-person working group (leads for the two Community Partners [MomsFirst™ and Community Endeavors Foundation™] and the academic partner [LF]) then created a draft intervention, guided, and revised with input from nine focus groups (including AA/B mothers, fathers/partners, CHWs serving the mothers and their supervising case managers) in a methodology called “broad involvement design.”8–11 The modules were iteratively revised with input from a board-certified lactation consultant, the focus groups, literature review, and community partners’ key staff.
The initial clinical trial implementing BFS was conducted in the City of Cleveland in collaboration with Community Partners MomsFirst™ and Community Endeavors Foundation™. 7 BFS and BEST Conduct–-CHWs presented BFS modules sequentially to all MBF mothers virtually or in-home as preferred and possible, measured mothers for bras, and delivered the breastfeeding supplies. CHWs were able to deliver more than one module at a given visit or point of contact per their assessment of maternal engagement and interest. A WIC breastfeeding peer helper served as the BFS lay lactation specialist and conducted the postnatal lactation visit. CHWs gathered all demographic and outcomes data. The research leadership team (D.H. and L.F.) met weekly during active study conduct to assure adherence to protocol.
Data collection and outcome measures
Fidelity to BFS was measured as the number of modules presented (dichotomized to all 11 versus <11), whether a complete set of breastfeeding supplies were delivered to the mother (yes versus no), and the occurrence of the postnatal lactation visit from the project-assigned lactation specialist (yes versus no). The primary BEST outcomes were breastfeeding initiation and continuation at 1 month. Only de-identified information was collected and an excel spreadsheet was used. Data were shared per executed institutional contracts. The secondary outcome was maternal satisfaction with BFS measured by a single 4-point Likert scored assessment (“In general, would you say that your experience with BFS [helped a lot with breastfeeding, helped some with breastfeeding, helped a little with breastfeeding, did not really help with breastfeeding]”). Maternal surveys were collected within UH REDCap, a data capture, access, and retrieval system. 12 The exploratory outcome was 1 month exclusive breastfeeding.
Statistical analysis
Sample size calculation was based on the most recent data available at study start (2019) of an all-Ohio ever breastfeeding at hospital discharge for AA/B moms rate of 67.5% (https://odh.ohio.gov/wps/portal/gov/odh/know-our-programs/Breastfeeding/Data). A priori power analysis, based with an alpha level of 0.05 and statistical power of 80%, determined a minimum of 54 participants were needed. We planned for a 10–20% drop out rate. We calculated baseline differences using independent t-test for continuous variables, and chi-square test or fisher’s exact test for categorical variables. We used estimates of odds ratios and 95% confidence intervals (CI) to describe differences in outcomes. The p values of α < 0.05 were considered statistically significant.
Results
Of 73 eligible women, 62 agreed to participate, of whom 4 exited the MBF program due to becoming unreachable and were withdrawn, resulting in 58 participants. The majority were AA/B (48, 83%), had an income <200% poverty level (55, 95%), and were unmarried (57, 98%); mean age was 25.8 years (SD 5.5) (Table 1). With respect to intervention fidelity, 53 participants (91%) completed all 11 modules, all participants (100%) received full breastfeeding supplies, and 55 (95%) had a postpartum lactation specialist visit. Of the five participants not completing all 11 modules, one completed 10 modules, two completed 9 modules, and two completed 8 modules. With respect to enrollment timing, 21 participants (36.2%) were enrolled in the first trimester, 20 (34.5%) in the second trimester, and 17 (29.3%) in the third trimester of pregnancy.
Characteristics of BEST Trial Patients, Stratified by Whether All Program Modules Were Completed Versus Not Completed
Same as BEST study trimester enrolled.
Most participants (57, 98%) initiated breastfeeding and continued to breastfeed at 1 month postpartum; 53 (91%) exclusively breastfed at this time point. Most (54, 93%) expressed their milk and fed breastmilk in a bottle to their infant. Timing of enrollment (first or second trimester versus third trimester) was not significantly associated with outcomes (Table 2). Of the 49 participants (84%) who completed the Likert-based satisfaction survey, 42 (86%) endorsed that BFS “helped a lot with breastfeeding,” 6 (12%) endorsed “helped some,” 1 endorsed “helped a little,” and none said, “did not really help.”
Outcomes of Study Mothers, Categorized by Early Enrollment (Early, Within First or Second Trimester), and Late Enrollment (Late, Within Third Trimester), Including Odds Ratios (OR) and 95% Confidence Intervals (CI)
Discussion
This study successfully demonstrated that, in a new geographic and program setting, a modular interactive breastfeeding curriculum including breastfeeding supplies and a postpartum lactation specialist visit, called BFS, when piggy-backed onto home visiting by CHWs as part of a comprehensive pregnancy and postnatal program, was associated with high rates of breastfeeding initiation and 1-month continuation and exclusivity among AA/B women at risk for not breastfeeding. In the initial BFS study, we found that module “dose” (number of modules received) was significantly associated with breastfeeding outcome; in this study CHWs achieved high fidelity and most mothers received all modules. 7 Even when mothers joined MBF late in pregnancy (third trimester), BFS was not less effective in supporting breastfeeding; this is reassuring pragmatic implementation information.
Most participants (54/58) reported expressing their milk and feeding it in a bottle to their infant. We did not obtain qualitative information about milk expression and do not know whether milk expression was combined with feeding at the breast or was exclusive. BFS does not directly address milk expression beyond encouraging mothers that milk expression is a choice and can be used to increase milk supply. Relevant research is mixed on whether milk expression, especially exclusive expression, shortens or lengthens duration of breastfeeding.13–15 A recent large study showed that milk expression was associated with a 37% lower hazard of breastfeeding cessation (adjusted hazard ratio 0.63; 95% CI: 0.56–0.70), which on analysis stratified by race showed the lowest hazard of cessation (0.47 [0.40–0.54]) among non-Hispanic black mothers. 15 This area is an important one for future study. Strengths of this study include successful enrollment of sufficient participants to answer the research question, excellent fidelity to BFS, excellent staff engagement and flexibility with respect to virtual and in-person format. Study limitations include the absence of qualitative information beyond the single item satisfaction survey. Additionally, the study was conducted at a single location without randomization or a control arm or a waitlisting approach because both the academic and community partner considered non-receipt of BFS ethically unacceptable. This study design limits assignation of causality. Prior breastfeeding data specific to the MBF Program is not available for comparison; however, use of historical controls can be problematic due to differences between the historical and treatment groups. 16 The most recent breastfeeding initiation rate published for Lucas County (where MBF is located) is 64.6%, which differs meaningfully from the rate of breastfeeding initiation in this report; a statistical comparison is not possible. 17
Nurse and CHW-led home-visiting programs for expectant women benefit many aspects of maternal-child health, and CHW home visiting has been shown to decrease rates of premature birth.18,19 While standard CHW-led home-visiting curricula in the United States include breastfeeding information, only in low and middle income countries has CHW-led home visiting been shown to increase breastfeeding rates.20,21 These results reveal an opportunity to augment CHW home-visiting curricula with effective and culturally appropriate breastfeeding materials to increase breastfeeding rates among predominantly low-income AA/B women at risk for not breastfeeding.
Notable advantages of BFS include evidence-based effectiveness demonstrated in two settings, low training burden for CHWs, ready availability of the program materials and curriculum, and the comparatively low cost per mother ($60) of the intervention. BFS is not simply an educational program that delivers breastfeeding content. Rather it tackles structural racism and social determinants of health that impact risk for not breastfeeding in additive ways: (1) the mechanism of delivery via CHWs provides peer-led community-based support, (2) the inclusion of a scheduled lay lactation specialist (WIC Peer or Certified Lactation Counselor) pre- and postnatal visit overcomes referral, transportation, and scheduling barriers to timely posthospital lactation care, (3) provision of breastfeeding bras, pads, and lanolin overcomes income-based lack of needed breastfeeding supplies, (4) Section 2 (“Who will support me While Breastfeeding?”) uses a question guide to prompt dialog with the mother’s partner, whose involvement is often disregarded due to non-cohabitation, and (5) other modules similarly use interactive approaches to problem solving and basic breastfeeding issues that support the mother’s autonomy, which historically has been disregarded by hospital-based providers. 22
The benefits of breastfeeding are the cornerstone of child and maternal health, and the BFS intervention cost can be compared with the “health, human capital, and economic costs” of not breastfeeding. 23 Using the “Cost of Not Breastfeeding Tool,” developed by Dr. Dylan Walters and Alive & Thrive with funding from the Bill & Melinda Gates Foundation, 24 the total cost of not breastfeeding in the United States is estimated as $167.9 billion. Using U.S. Census data (https://www.census.gov/quickfacts/US) to estimate the number of women of child-bearing age, the cost of not breastfeeding per woman of child-bearing age per year in the United States is approximately $1,382 per mother. Alternate approaches yield similar results 25 and can be directly compared with the cost of BFS. The overall value of full and equitable breastfeeding for society goes beyond economic calculus, but monetary costs must be considered by public health authorities when considering program implementation and BFS stands up to scrutiny.
Future directions for the BFS Program include continuation of the program at the MBF Program in Toledo and expansion to Home Visiting Programs sponsored by the Ohio Department of Health that serve families at risk for not breastfeeding. Additional funding is being sought and the program readily scales to need. The program is not limited to the state of Ohio and can be adapted for local use with home-visiting programs with CHWs already in place in other locales. Programmatic updates, conducted prior to this trial and anticipated for future trials, as well as new research that examines the role of milk expression and includes more qualitative participant feedback within BFS will be needed.
Conclusion
Breastfeeding is a public health priority with known racial inequity, and BFS fills a critical curricular and impact gap with respect to breastfeeding support. While the study was conducted with an unblinded single cohort design for ethical reasons, and hence causality cannot be assumed, public health programs can add BFS to CHW-led home-visiting curricula with a reasonable expectation of increased breastfeeding among at-risk mothers.
Footnotes
Acknowledgments
Thank you to Bravado Bras (bravadodesigns.com) for enabling purchase of study nursing bras through their WIC Bra Catalog. Thank you to Meredith Smith, MS, RD, LD, CLS, Title V Breastfeeding Coordinator, Bureau of Child and Family Health, Ohio Department of Health, for her support throughout.
Authors’ Contributions
D.H.: Validation, investigation, data curation, writing—review and editing, supervision, and project administration. J.P.: Data curation, formal analysis, visualization, and writing—review and editing. L.F.: Conceptualization, methodology, validation, resources, data curation, writing—original draft, visualization, supervision, project administration, and funding acquisition.
Disclosure Statement
The authors have no financial or other conflicts of interest to disclose.
Funding Information
This work was funded by a grant from the
