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) — BEHAVIORALClinically-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 careStandard 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 CareIn 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
- Lauren Keenan-Devlin, MPH, PhD8475701971
- Ashley B Walther, MS8475702652
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Swedish Hospital | Chicago | Illinois | 60625 | |
| UChicago Medicine Hospital (University of Chicago) | Chicago | Illinois | 60637 | |
| Endeavor Health (NorthShore University HealthSystem) | Evanston | Illinois | 60201 | Robert Stanton, JD |
| Highland Park Hospital | Highland Park | Illinois | 60035 |
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