Breastfeeding
Conditions
Keywords
Breastfeeding, Peer Counseling, Lay health worker, Infant Feeding
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.
Interventions
BEHAVIORALCi-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.
Sponsors
Patient-Centered Outcomes Research Institute
Northwestern University
University of Chicago
Rush University
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding duration | 6 weeks postpartum | Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding intensity-inpatient | 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. |
| Breastfeeding intensity-post discharge | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Out of pocket cost | 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) |
| Breastfeeding knowledge | Baseline 12-20 weeks | Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding |
| Feeding related opportunity costs | 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) |
| Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS) | 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. |
| Ci-BPC related costs | 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. |
Countries
United States
Contacts
Primary ContactLauren Keenan-Devlin, MPH, PhD
Backup ContactAshley B Walther, MS
Outcome results
None listed