Clinical trial NCT05441709: Furthering Equity Through Infant Feeding EDucation and Support
Official title: Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Peer Counseling
Lay health worker
Infant Feeding
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Northwestern University
name: University of Chicago
name: Rush University
First posted: 2022-07-01
Enrollment: 970
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to either standard lactation care or to standard lactation care plus clinically-integrated breastfeeding peer counseling
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 12 and 20 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

Primary outcomes:
measure: Breastfeeding duration
timeFrame: 6 weeks postpartum
measure: Breastfeeding duration
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Breastfeeding intensity-inpatient
timeFrame: During Delivery Admission
measure: Breastfeeding intensity-post discharge
timeFrame: 6 weeks postpartum
measure: Breastfeeding intensity-post discharge
timeFrame: 6 months postpartum
Other outcomes:
measure: Breastfeeding knowledge
timeFrame: Baseline 12-20 weeks
measure: Breastfeeding knowledge
timeFrame: 6 weeks postpartum
measure: Breastfeeding knowledge
timeFrame: 6 months postpartum
measure: Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: Baseline 12-20 weeks
measure: Ci-BPC related costs
timeFrame: 6 weeks postpartum
measure: Out of pocket cost
timeFrame: 6 weeks postpartum
measure: Feeding related opportunity costs
timeFrame: 6 weeks postpartum
measure: Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: 6 weeks postpartum
measure: Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: 6 months postpartum
Locations:
city: Chicago
country: United States
facility: Swedish Hospital
state: Illinois
city: Chicago
country: United States
facility: UChicago Medicine Hospital (University of Chicago)
state: Illinois
city: Evanston
country: United States
facility: Endeavor Health (NorthShore University HealthSystem)
state: Illinois
city: Highland Park
country: United States
facility: Highland Park Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health (NorthShore University HealthSystem)
name: Ann Borders, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: