Furthering Equity Through Infant Feeding EDucation and Support

NCT05441709 | Recruiting DMC

• 1 other identifier: EH20-406
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 4

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

Keywords

Breastfeeding; Peer Counseling; Lay health worker; Infant Feeding

Outcome Measures

Primary Outcomes (2)

• Breastfeeding duration

  Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.

  6 weeks postpartum

• Breastfeeding duration

  Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.

  6 months postpartum

Secondary Outcomes (3)

• Breastfeeding intensity-inpatient

  During Delivery Admission

• Breastfeeding intensity-post discharge

  6 weeks postpartum

• Breastfeeding intensity-post discharge

  6 months postpartum

Other Outcomes (9)

• Breastfeeding knowledge

  Baseline 12-20 weeks

• Breastfeeding knowledge

  6 weeks postpartum

• Breastfeeding knowledge

  6 months postpartum

Study Arms (2)

Standard of care

NO 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.

ci-BPC with Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Ci-BPC with Standard of Care (SOC)

Interventions

Ci-BPC with Standard of Care (SOC) BEHAVIORAL

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.

ci-BPC with Standard of Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Endeavor Health: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Northwestern University: collaborator
• University of Chicago: collaborator
• Rush University: collaborator

Study Sites (4)

Swedish Hospital

Chicago, Illinois, 60625, United States

RECRUITING

UChicago Medicine Hospital (University of Chicago)

Chicago, Illinois, 60637, United States

RECRUITING

Endeavor Health (NorthShore University HealthSystem)

Evanston, Illinois, 60201, United States

NOT YET RECRUITING

Highland Park Hospital

Highland Park, Illinois, 60035, United States

RECRUITING

Related Publications (1)

• Keenan-Devlin LS, Smart BP, Hirschhorn L, Meier P, Jefferson U, Solomonides A, Wang CE, Handler A, Silver RK, Borders AEB. Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity. Am J Perinatol. 2024 May;41(S 01):e2313-e2325. doi: 10.1055/s-0043-1771255. Epub 2023 Jul 21.

  PMID: 37494586 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ann Borders, MD, MS

  Endeavor Health (NorthShore University HealthSystem)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Keenan-Devlin, MPH, PhD

CONTACT

8475701971; lkeenan-devlin@northshore.org

Ashley B Walther, MS

CONTACT

8475702652; awalther@northshore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized 1:1 to either standard lactation care or to standard lactation care plus clinically-integrated breastfeeding peer counseling

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 1, 2022
• Study Start: November 8, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (4)