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NCT Number: NCT05441709

Furthering Equity Through Infant Feeding EDucation and Support

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.

Recruiting

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ci-BPC with Standard of Care (SOC)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Breastfeeding knowledge

    Time frame: Baseline 12-20 weeks

    Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

  2. Breastfeeding knowledge

    Time frame: 6 weeks postpartum

    Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

  3. Breastfeeding knowledge

    Time frame: 6 months postpartum

    Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

  4. 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.

  5. 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. 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)

  7. 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)

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley B Walther, MS

CONTACT

[email protected]

8475702652

Lauren Keenan-Devlin, MPH, PhD

CONTACT

[email protected]

8475701971

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

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

Registry information

Official study title

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity

Acronym: FEEDS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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