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Recruiting NCT05441709

Furthering Equity Through Infant Feeding EDucation and Support

No phase Interventional Breastfeeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ci-BPC with Standard of Care (SOC).
Who it may be relevant to
Registry conditions: Breastfeeding. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity

Overview

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

Interventions

  • Behavioral 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 organiz

Primary outcome measures

  • Breastfeeding duration [Time frame: 6 weeks postpartum]
  • Breastfeeding duration [Time frame: 6 months postpartum]
Secondary outcome measures (3)
  • Breastfeeding intensity-inpatient [Time frame: During Delivery Admission]
  • Breastfeeding intensity-post discharge [Time frame: 6 weeks postpartum]
  • Breastfeeding intensity-post discharge [Time frame: 6 months postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Swedish Hospital — Chicago
  • UChicago Medicine Hospital (University of Chicago) — Chicago
  • Endeavor Health (NorthShore University HealthSystem) — Evanston
  • Highland Park Hospital — Highland Park

Publications

  • 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. PMID 37494586

Identifiers

NCT: NCT05441709 · EH20-406

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗