Breastfeeding Support for Enhancing Equity

(FEEDS Trial)

Recruiting at 4 trial locations

Overseen By Ashley B Walther, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Endeavor Health

Disqualifiers: Pregnancy termination, Adoption, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

970 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding peer support to standard breastfeeding care helps Black and Hispanic/Latine families breastfeed longer and more intensively. It compares the usual care provided by nurses and lactation consultants to a new approach called Clinically Integrated Breastfeeding Peer Counseling (ci-BPC), which includes additional support from peer counselors. These counselors guide families from pregnancy through postpartum and are available for follow-up calls. This study suits English or Spanish-speaking expectant parents, between 12 and 24 weeks pregnant, who plan to give birth at specific hospitals and have not previously used this peer support. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance breastfeeding support for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that clinically integrated breastfeeding peer counseling (ci-BPC) is safe?

Research shows that Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) is generally safe and well-received by participants. Studies have not found any negative effects from this type of peer counseling. Instead, ci-BPC has proven effective in increasing both the frequency and duration of breastfeeding among mothers. This indicates that the program is not only safe but also effective in helping families achieve their breastfeeding goals. No evidence suggests that ci-BPC poses any risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) because it offers personalized support through peer counselors, enhancing the standard lactation care provided by registered nurses and International Board Certified Lactation Consultants (IBCLCs). Unlike traditional methods that rely solely on professional healthcare providers, ci-BPC integrates peer counselors at multiple stages of the perinatal period, providing tailored guidance and support that can be more relatable and accessible. Additionally, the inclusion of a "warmline" for timely follow-up sets this approach apart by ensuring ongoing, responsive support for new mothers. This could potentially improve breastfeeding outcomes and offer more equitable access to care.

What evidence suggests that clinically integrated breastfeeding peer counseling (ci-BPC) is effective for reducing disparities in breastfeeding intensity and duration?

Research shows that Clinically Integrated Breastfeeding Peer Counseling (ci-BPC), offered alongside standard care in this trial, can help mothers breastfeed more successfully. Studies have found that ci-BPC increases both the frequency and duration of breastfeeding, particularly in low-income communities and among families of color. This method provides education and support about breastfeeding before birth and continues to assist after the baby is born. Previous research linked ci-BPC to more exclusive breastfeeding and longer breastfeeding periods. These findings suggest that ci-BPC could help reduce disparities in breastfeeding success among different groups. ^{1 2 3 6 7}

Who Is on the Research Team?

Ann Borders, MD, MS

Principal Investigator

Endeavor Health (NorthShore University HealthSystem)

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking individuals between 12 and 20 weeks pregnant, planning to parent their infant and deliver at SH or HPH hospitals. It's aimed at those who haven't had prior exposure to clinically integrated breastfeeding peer counseling (ci-BPC).

Inclusion Criteria

I am between 12 and 20 weeks pregnant.

Planning to deliver at SH or HPH

I have never been treated with ci-BPC.

Exclusion Criteria

I have previously been treated with ci-BPC.

Considering pregnancy termination or adoption

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Education

Participants receive a dedicated prenatal infant feeding education encounter

Up to 30 weeks gestation

1 visit (in-person or virtual)

Inpatient Care

Participants receive standard lactation care and ci-BPC during the delivery admission

During delivery admission

At least 1 visit (in-person)

Postpartum Support

Participants receive postpartum lactation support and access to a warmline for follow-up

6 weeks postpartum

At least 1 visit (in-person or virtual), phone follow-up

Follow-up

Participants are monitored for breastfeeding knowledge, attitude, and duration

6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Clinically Integrated Breastfeeding Peer Counseling (ci-BPC)

Trial Overview The study examines if adding ci-BPC to standard lactation care helps reduce the gap in how long and how intensely Black and Hispanic/Latine families breastfeed.

How Is the Trial Designed?

Group I: Standard of care Active Control 1 Intervention

Standard lactation care is provided by postpartum RNs on the inpatient unit and RNs who are board certified in lactation (IBCLCs).Postpartum RNs provide support to all patients post delivery with direct breastfeeding, breast pump use, and addressing routine breastfeeding concerns. IBCLCs provide direct lactation care for more complicated lactation problems and is delivered in a dosed manner based on the nature of the lactation problem, with low-risk patients often having no encounters.

Group II: ci-BPC with Standard of Care Active Control 1 Intervention

In addtion to normal standard of care (as described above), patients will also receive clinically-integrated breastfeeding peer counseling (ci-BPC) from a Peer Counselor at four timepoints throughout the perinatal period. The encounters will take place either in person or virtually and include: an intake encounter between 2- and 30 weeks gestation, a dedicated prenatal infant feeding education encounter, at least one inpatient encounter post-delivery during the delivery admission, and at least one postpartum encounter. Patients will also have access to a "warmline" that will include phone follow up by the next business day.

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A telephone peer counseling program for WIC participants significantly increased the duration of nonexclusive breastfeeding at 3 months postpartum, with an adjusted relative risk of 1.22, indicating a positive impact on breastfeeding support.

The program showed modest improvements in exclusive breastfeeding duration, particularly among Spanish-speaking clients, who had a lower likelihood of ceasing exclusive breastfeeding (adjusted odds ratio: 0.78).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone peer counseling of breastfeeding among WIC participants: a randomized controlled trial. Reeder, JA., Joyce, T., Sibley, K., et al.[2021]

The Integrated Model of peer counseling for breastfeeding support, which included fewer home visits and more clinic and group education contacts, was feasible and did not negatively impact overall breastfeeding outcomes among 698 participants across multiple counties.

Participants in the Integrated Model had a significantly lower risk of discontinuing exclusive breastfeeding by 3 months postpartum compared to those in the Standard Model, although group education classes were linked to higher rates of breastfeeding discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Model of Breastfeeding Peer Counseling Support is Feasible and Associated with Improved Exclusive Breastfeeding. Rozga, MR., Benton, PA., Kerver, JM., et al.[2022]

Women who enrolled in the peer counseling breastfeeding support program after giving birth (postnatal) breastfed for significantly longer than those who enrolled before giving birth (prenatal), suggesting that postnatal support may be more effective.

Participants who exited the program while still breastfeeding had longer breastfeeding durations compared to those who discontinued altogether, indicating that targeted support for women at risk of stopping breastfeeding could enhance overall program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritization of resources for participants in a peer counseling breastfeeding support program. Rozga, MR., Kerver, JM., Olson, BH.[2021]

Peer counseling has been shown to be an effective intervention for promoting breastfeeding among low-income women, highlighting its potential in healthcare settings.

The paper also identifies barriers that limit the integration of peer counseling into medical settings, suggesting that addressing these challenges could enhance breastfeeding support programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding peer counseling: rationale for the National WIC Survey. Bronner, Y., Barber, T., Miele, L.[2017]

This study is the largest randomized control trial of clinically integrated Breastfeeding Peer Counseling (ci-BPC) in the U.S., involving 720 participants from diverse racial and ethnic backgrounds, aimed at reducing breastfeeding disparities among Black and Hispanic/Latine mothers.

The primary outcome is to assess breastfeeding duration, with additional measures of breastfeeding intensity at various points postpartum, which will provide valuable insights into the effectiveness of ci-BPC in supporting breastfeeding goals and improving maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity. Keenan-Devlin, LS., Smart, BP., Hirschhorn, L., et al.[2023]

A systematic review of 26 studies found that breastfeeding peer counseling significantly improves rates of breastfeeding initiation, duration, and exclusivity, indicating its effectiveness as a supportive intervention.

Peer counseling not only enhances breastfeeding practices but also contributes to better health outcomes, such as reducing infant diarrhea and increasing the duration of lactational amenorrhea, making it a valuable component of maternal-child health programs globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding peer counseling: from efficacy through scale-up. Chapman, DJ., Morel, K., Anderson, AK., et al.[2022]

Breastfeeding peer counseling (BPC) provided significant educational, emotional, and social support to African American mothers in WIC, positively influencing their breastfeeding experiences.

The study identified four key themes highlighting the benefits of BPCs, including increased confidence and support in countering negativity, but noted variability in the quality of contact between different WIC clinics, suggesting a need for standardized guidelines for BPC programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactions of Low-Income African American Women to Breastfeeding Peer Counselors. Robinson, K., VandeVusse, L., Foster, J.[2022]

The introduction of a peer counselor in a prenatal clinic did not significantly increase breastfeeding continuation at 6 weeks postpartum, with rates of 55.6% for those with a counselor compared to 49.1% without.

However, women who received support from a peer counselor reported higher satisfaction with breastfeeding training (98.2% vs. 83.6%) and were more likely to initiate breastfeeding (89.8% vs. 78.9%), suggesting that peer counseling can enhance the initial breastfeeding experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Real-world" effect of a peer counselor on breastfeeding outcomes in an urban prenatal clinic in the United States. Martinez, NG., Strohbach, A., Hu, F., et al.[2021]

The New Jersey WIC program successfully established a Breastfeeding Consortium that improved collaboration among breastfeeding educators, support groups, and healthcare providers, enhancing community support for breastfeeding.

The initiative led to better communication and resource sharing, exemplified by the creation of a directory of breastfeeding services and promotional displays, which have effectively increased breastfeeding awareness and support in the county.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consortium building: wide-base support and promotion of breastfeeding in the community. Knipscher, CD.[2017]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37494586/

Clinically Integrated Breastfeeding Peer Counseling to ... This study aimed to determine whether clinically integrated Breastfeeding Peer Counseling (ci-BPC) added to usual lactation care reduces disparities in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38750195/

Implementation of a clinically integrated breastfeeding peer ... Results: ci-BPC improved breastfeeding intensity and duration by providing every NSCHC patient with (1) prenatal lactation education; (2) hands ...

3. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06395-1

The role of clinic-based breastfeeding peer counseling on ... Breastfeeding Peer Counseling (BPC) has been found to improve breastfeeding outcomes for low-income communities and families of color. A ...

4. semanticscholar.org semanticscholar.org/paper/b089c340b1860bf7f4e7d3c7bd0736cfad449ff0

Clinically integrated breastfeeding peer counseling and ... Ci-BPC was associated with significant improvement in breastfeeding exclusivity and duration, and may address breastfeeding disparities, ...

5. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0043-1771255

Clinically Integrated Breastfeeding Peer Counseling to ... Results The primary outcome will be breastfeeding duration. Additional outcomes will include the proportion of breastmilk feeds during the delivery admission, ...

6. researchgate.net researchgate.net/publication/372655195_Clinically_Integrated_Breastfeeding_Peer_Counseling_to_Promote_Breastfeeding_Equity

Clinically Integrated Breastfeeding Peer Counseling to ... Objective This study aimed to determine whether clinically integrated Breastfeeding Peer Counseling (ci-BPC) added to usual lactation care ...

7. ovid.com ovid.com/journals/ajper/pdf/10.1055/s-0043-1771255~clinically-integrated-breastfeeding-peer-counseling-to

Clinically Integrated Breastfeeding Peer Counseling to ... Aim 2 analysis plan: to determine whether ci-BPC added to usual lactation care improves breastfeeding outcomes via improved knowledge ...