Furthering Equity Through Infant Feeding EDucation and Support (FEEDS)

Endeavor Health

Status: Enrolling

Conditions: Breastfeeding

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05441709

EH20-406

Details and patient eligibility

About

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.

Full 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, (3) To understand implementation outcomes, facilitators, and barriers, and (4) To identify associated patient centered costs.

Enrollment: 990 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 12 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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990 participants in 2 patient groups

Standard of care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

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