Furthering Equity Through Infant Feeding EDucation and Support

Breastfeeding Clinical Trial

— FEEDS  

Official title:

Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441709
• Other study ID #: EH20-406
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: NorthShore University HealthSystem
• Contact: Lauren Keenan-Devlin, MPH, PhD
• Phone: 8475701971
• Email: lkeenan-devlin[@]northshore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and (3) To understand implementation outcomes, facilitators, and barriers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	Swedish Hospital	Chicago	Illinois
United States	UChicago Medicine Hospital (University of Chicago)	Chicago	Illinois
United States	Endeavor Health (NorthShore University HealthSystem)	Evanston	Illinois
United States	Highland Park Hospital	Highland Park	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Northwestern University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breastfeeding knowledge	Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding	Baseline 12-20 weeks
Other	Breastfeeding knowledge	Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding	6 weeks postpartum
Other	Breastfeeding knowledge	Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding	6 months postpartum
Other	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.	Baseline 12-20 weeks
Other	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.	6 weeks postpartum
Other	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.	6 months postpartum
Primary	Breastfeeding duration	Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.	6 weeks postpartum
Primary	Breastfeeding duration	Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.	6 months postpartum
Secondary	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.	During Delivery Admission
Secondary	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.	6 weeks postpartum
Secondary	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.	6 months postpartum