Furthering Equity Through Infant Feeding EDucation and Support
NCT ID: NCT05441709
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
990 participants
INTERVENTIONAL
2022-11-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior exposure to ci-BPC
18 Years
45 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Northwestern University
OTHER
University of Chicago
OTHER
Rush University
OTHER
Endeavor Health
OTHER
Responsible Party
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Ann Borders
Principal Investigator
Principal Investigators
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Ann Borders, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health (NorthShore University HealthSystem)
Locations
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Swedish Hospital
Chicago, Illinois, United States
UChicago Medicine Hospital (University of Chicago)
Chicago, Illinois, United States
Endeavor Health (NorthShore University HealthSystem)
Evanston, Illinois, United States
Highland Park Hospital
Highland Park, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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EH20-406
Identifier Type: -
Identifier Source: org_study_id
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