Recruiting

ci-BPC

Sponsor:

Endeavor Health

Code:

NCT05441709

Conditions

Breastfeeding

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Ci-BPC with Standard of Care (SOC)

Study Details

Brief summary:

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.

Conditions

Breastfeeding

Study ID

NCT05441709

Start date

Nov 8, 2022

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 12 and 24 weeks gestation
  • English or Spanish speaking
  • Planning to parent their infant
  • Planning to deliver at SH, HPH or UCM
  • No prior exposure to ci-BPC

Exclusion Criteria:

  • considering pregnancy termination or adoption
  • Prior exposure to ci-BPC

Study Design

Enrollment

990 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of care

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.

active comparator: ci-BPC with Standard of Care

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.

Interventions

Ci-BPC with Standard of Care (SOC)

Clinically-integrated breastfeeding peer counseling (ci-BPC) is a practice that, supports the patient and the clinical care team by delivering culturally-appropriate breastfeeding help to motivate breastfeeding initiation, intensity, and duration, inspiring confidence for patients to set breastfeeding goals and meet them. ci-BPC is delivered by community health workers who have breastfed an infant, and have received basic training in breastfeeding support through a qualified BPC training organization. For this project, the Peer Counselor will make initial contact to patients randomized into the treatment arm via phone to schedule the Intake Encounter between 20 and 30 weeks gestation. Subsequently, each patient will receive a minimum of 3 additional encounters which can occur virtually or in-person. Patients randomized to the ci-BPC arm are additionally offered access to a "warmline" where messages will be returned by the next business day.

Primary outcome measure

  • Breastfeeding duration [ Time Frame: 6 weeks postpartum ]
  • Breastfeeding duration [ Time Frame: 6 months postpartum ]

Central Contacts and Locations

Central contacts

Lauren Keenan-Devlin, MPH, PhD

8475701971lkeenan-devlin@northshore.org

Locations

Swedish Hospital

Recruiting

Chicago, Illinois, United States, 60625

Contacts

Lauren Keenan-Devlin, PhD, MPH

8475701971lkeenan-devlin@northshore.org

UChicago Medicine Hospital (University of Chicago)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Lauren Keenan-Devlin, PhD, MPH

8475701971groberts@northshore.org

Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Lauren Keenan-Devline, PhD, MPH

8475701971groberts@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • Breastfeeding
  • Peer Counseling
  • Lay health worker
  • Infant Feeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2025-12-09.