Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05441709

Furthering Equity Through Infant Feeding EDucation and Support

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
990 (estimated)
Sponsor
Endeavor Health · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALCi-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.

Timeline

Start date
2022-11-08
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2022-07-01
Last updated
2025-12-09

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05441709. Inclusion in this directory is not an endorsement.