Furthering Equity Through Infant Feeding EDucation and Support

Not Applicable

Recruiting

• Conditions: Breastfeeding
• Interventions: Behavioral: Ci-BPC with Standard of Care (SOC)

• Registration Number: NCT05441709
• Lead Sponsor: NorthShore University HealthSystem

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.

Detailed Description

FEEDS is a randomized control trial comparing standard lactation care to standard lactation care plus a ci-BPC. This trial will take place at three hospitals in the Chicago land area, Swedish Hospital, Highland Park Hospital, and University of Chicago Medicine Hospital. The aims of the study are: (1) To determine whether ci-BPC reduces disparities in breastfeeding outcomes for Black and Hispanic/Latine participants, (2)To determine whether ci-BPC improves breastfeeding knowledge, attitude, access to support, and empowerment and (3) To understand implementation outcomes, facilitators, and barriers.

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Study Start: 2022-11-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• 12 and 20 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ci-BPC with Standard of Care	Ci-BPC with Standard of Care (SOC)	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 Measures

Name	Time	Method
Breastfeeding duration	6 months postpartum	Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding intensity-post discharge	6 months postpartum	Proportion of infant feedings that are breastmilk only. Intensity will be calculated as # breastmilk feeds/day divided by total number of infant feedings/day as recorded in the infant feeding logs completed by study participants.
Breastfeeding intensity-inpatient	During Delivery Admission	Proportion of infant feedings during the delivery admission that are breastmilk only. Number of breastmilk feeds will be divided by the total number of infant feedings.

Trial Locations

Locations (4)

Highland Park Hospital; 🇺🇸 Highland Park, Illinois, United States

UChicago Medicine Hospital (University of Chicago); 🇺🇸 Chicago, Illinois, United States

Endeavor Health (NorthShore University HealthSystem); 🇺🇸 Evanston, Illinois, United States

Swedish Hospital; 🇺🇸 Chicago, Illinois, United States