Furthering Equity Through Infant Feeding EDucation and Support

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Endeavor Health
Study ID
NCT05441709
Status
Recruiting

Conditions

  • Breastfeeding

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Nov 8, 2022
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
990 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Breastfeeding duration [ Time Frame: 6 weeks postpartum ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Swedish HospitalChicagoIllinois60625
Lauren Keenan-Devlin, PhD, MPH
8475701971
UChicago Medicine Hospital (University of Chicago)ChicagoIllinois60637
Lauren Keenan-Devlin, PhD, MPH
8475701971
Endeavor Health (NorthShore University HealthSystem)EvanstonIllinois60201
Robert Stanton, JD
Highland Park HospitalHighland ParkIllinois60035
Lauren Keenan-Devline, PhD, MPH
8475701971

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