Furthering Equity Through Infant Feeding EDucation and Support (FEEDS)

December 6, 2025 updated by: Ann Borders, Endeavor Health

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

990

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60625
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • UChicago Medicine Hospital (University of Chicago)
        • Contact:
      • Evanston, Illinois, United States, 60201
        • Not yet recruiting
        • Endeavor Health (NorthShore University HealthSystem)
        • Contact:
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • Highland Park Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding intensity-inpatient
Time Frame: 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.
During Delivery Admission
Breastfeeding intensity-post discharge
Time Frame: 6 weeks 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.
6 weeks postpartum
Breastfeeding intensity-post discharge
Time Frame: 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.
6 months postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding knowledge
Time Frame: Baseline 12-20 weeks
Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding
Baseline 12-20 weeks
Breastfeeding knowledge
Time Frame: 6 weeks postpartum
Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding
6 weeks postpartum
Breastfeeding knowledge
Time Frame: 6 months postpartum
Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding
6 months postpartum
Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
Time Frame: Baseline 12-20 weeks
The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula.
Baseline 12-20 weeks
Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
Time Frame: 6 weeks postpartum
The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula.
6 weeks postpartum
Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
Time Frame: 6 months postpartum
The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula.
6 months postpartum
Ci-BPC related costs
Time Frame: 6 weeks postpartum
The time spent in BPC inpatient encounters, outpatient/telehealth appointments and support group sessions, travel time for BPC appointments, transportation for BPC appointments, and cellular data for telehealth BPC appointments.
6 weeks postpartum
Out of pocket cost
Time Frame: 6 weeks postpartum
Supplies purchased for infant feeding, including breastfeeding supplies (e.g., pump and parts, storage, contained, bras, breast pads, billows), bottles, formula, and addition food cost (including supplements)
6 weeks postpartum
Feeding related opportunity costs
Time Frame: 6 weeks postpartum
Time spent feeding infants (preparation, feeding, and clean up) for type of feeding (breast milk at breast, breast milk by bottle, formula)
6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Collaborators

Patient-Centered Outcomes Research Institute
Northwestern University
University of Chicago
Rush University

Investigators

  • Principal Investigator: Ann Borders, MD, MS, Endeavor Health (NorthShore University HealthSystem)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 6, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH20-406

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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