970 Participants Needed

Breastfeeding Support for Enhancing Equity

(FEEDS Trial)

Recruiting at 4 trial locations
LK
BP
GG
AB
Overseen ByAshley B Walther, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Endeavor Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to identify whether adding clinically integrated breastfeeding peer counseling (ci-BPC) to standard lactation care is associated with a reduction in disparities in breastfeeding intensity and duration for Black and Hispanic/Latine families.

Will I have to stop taking my current medications?

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

Is breastfeeding peer counseling safe for participants?

Breastfeeding peer counseling, including models like Clinically Integrated Breastfeeding Peer Counseling (ci-BPC), has been widely studied and is generally considered safe for participants. The research shows it effectively supports breastfeeding without indicating any safety concerns for mothers or infants.12345

How is the Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) treatment different from other breastfeeding support methods?

Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) is unique because it integrates peer counselors directly into clinical settings to provide personalized breastfeeding support, aiming to reduce disparities in breastfeeding among Black and Hispanic/Latine communities. This approach differs from traditional methods by focusing on real-world, tailored support rather than following a strict research protocol.12678

What data supports the effectiveness of the treatment Clinically Integrated Breastfeeding Peer Counseling (ci-BPC)?

Research shows that peer counseling programs, like ci-BPC, are effective in increasing breastfeeding duration among low-income women and can help reduce disparities in breastfeeding outcomes for minority groups.12679

Who Is on the Research Team?

AB

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.
See 1 more

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?
2Treatment groups
Active Control
Group I: Standard of careActive Control1 Intervention
Group II: ci-BPC with Standard of CareActive Control1 Intervention

Find a Clinic Near You

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

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.
Breastfeeding peer counseling: rationale for the National WIC Survey.Bronner, Y., Barber, T., Miele, L.[2017]
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.
Reactions of Low-Income African American Women to Breastfeeding Peer Counselors.Robinson, K., VandeVusse, L., Foster, J.[2022]
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.
Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity.Keenan-Devlin, LS., Smart, BP., Hirschhorn, L., et al.[2023]

Citations

Breastfeeding peer counseling: rationale for the National WIC Survey. [2017]
Reactions of Low-Income African American Women to Breastfeeding Peer Counselors. [2022]
Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity. [2023]
"Real-world" effect of a peer counselor on breastfeeding outcomes in an urban prenatal clinic in the United States. [2021]
Prioritization of resources for participants in a peer counseling breastfeeding support program. [2021]
Telephone peer counseling of breastfeeding among WIC participants: a randomized controlled trial. [2021]
An Integrated Model of Breastfeeding Peer Counseling Support is Feasible and Associated with Improved Exclusive Breastfeeding. [2022]
Breastfeeding peer counseling: from efficacy through scale-up. [2022]
Consortium building: wide-base support and promotion of breastfeeding in the community. [2017]
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