Furthering Equity Through Infant Feeding EDucation and Support

ConditionBreastfeeding

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorEndeavor Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

12 and 24 weeks gestation

English or Spanish speaking

Planning to parent their infant

Planning to deliver at SH, HPH or UCM

Disqualifiers

considering pregnancy termination or adoption

Prior exposure to ci-BPC

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

990 Participants

are divided into 2 treatment groups

Group A: Standard of careNo intervention 0 interventions

Group B: ci-BPC with Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

Breastfeeding duration

Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.

Time frame

6 weeks postpartum

Breastfeeding duration

Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.

Time frame

6 months postpartum

Secondary outcomes

Breastfeeding intensity-inpatient

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.

Time frame

During Delivery Admission

Breastfeeding intensity-post discharge

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.

Time frame

6 weeks postpartum

Breastfeeding intensity-post discharge

Time frame

6 months postpartum

Other outcomes

Breastfeeding knowledge

Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

Time frame

Baseline 12-20 weeks

Breastfeeding knowledge

Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

Time frame

6 weeks postpartum

Breastfeeding knowledge

Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding

Time frame

6 months postpartum

Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)

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.

Time frame

Baseline 12-20 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endeavor Health

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Northwestern University

Collaborator

University of Chicago

Collaborator

Rush University

Collaborator

Source ClinicalTrials.gov

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