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Behavioral Intervention

Breastfeeding Support for Enhancing Equity (FEEDS Trial)

N/A

Recruiting

Led By Ann Borders, MD, MS

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

12 and 20 weeks gestation

No prior exposure to ci-BPC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postpartum

Awards & highlights

FEEDS Trial Summary

This trial will help researchers understand if adding breastfeeding peer counseling to standard lactation care can help reduce disparities in breastfeeding for Black and Hispanic/Latine families.

Who is the study for?

This trial is for English or Spanish-speaking individuals between 12 and 20 weeks pregnant, planning to parent their infant and deliver at SH or HPH hospitals. It's aimed at those who haven't had prior exposure to clinically integrated breastfeeding peer counseling (ci-BPC).Check my eligibility

What is being tested?

The study examines if adding ci-BPC to standard lactation care helps reduce the gap in how long and how intensely Black and Hispanic/Latine families breastfeed.See study design

What are the potential side effects?

Since this trial involves education and support interventions rather than medications, there are no typical side effects like you'd expect with drugs. However, participants may experience varying levels of emotional or psychological impact.

FEEDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 20 weeks pregnant.

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I have never been treated with ci-BPC.

FEEDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breastfeeding duration

Secondary outcome measures

Breastfeeding intensity-inpatient

Breastfeeding intensity-post discharge

Other outcome measures

Breastfeeding knowledge

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

FEEDS Trial Design

2Treatment groups

Active Control

Group I: Standard of careActive Control1 Intervention

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.

Group II: ci-BPC with Standard of CareActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER

1,586 Previous Clinical Trials

916,531 Total Patients Enrolled

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,140 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,996,728 Total Patients Enrolled

Media Library

Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05441709 — N/A

Breastfeeding Research Study Groups: Standard of care, ci-BPC with Standard of Care

Breastfeeding Clinical Trial 2023: Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) Highlights & Side Effects. Trial Name: NCT05441709 — N/A

Clinically Integrated Breastfeeding Peer Counseling (ci-BPC) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441709 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to participate in this clinical research?

"In order to participate in this research, patients must be between 18 and 45 years old and lactating. Ultimately the trial seeks 720 participants."

Answered by AI

Is the minimum age requirement for this research experiment above twenty years?

"This medical study is open to adults aged 18-45."

Answered by AI

Is this research currently recruiting participants?

"Unfortunately, judging from the information hosted on clinicaltrials.gov this specific trial is no longer actively searching for participants. The initial posting was made on November 1st 2022 and it has not been updated since September 26th 2022; however, there are currently 46 other active studies that may be of interest."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Furthering Equity Through Infant Feeding EDucation and Support

Ann Borders 2022. "Furthering Equity Through Infant Feeding EDucation and Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441709.