Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT

Completed · Not applicable

Conditions studied: Breastfeeding, Breastfeeding, Exclusive

In brief

This is a randomized, controlled, single-center, single-blind, 2x2 factorial design trial of routine provider, primary care-based interventions to increase breastfeeding intensity up to 6 months in low-income multiethnic women, with stratification for maternal country of birth. The Best Infant Nutrition for Good Outcomes (BINGO) trial will randomize women into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC + LC, or; (d) Control. Thus, the separate and synergistic effects of the interventions will be tested, compared to a Control standard of care. The intervention and design build upon our prior trial of an LC intervention alone. PNCs- certified nurse midwives and ob/gyns-- will use a brief, electronically prompted protocol with women in the PNC, and PNC + LC groups throughout pregnancy. An LC will arrange pre-natal one-on-one meetings, daily hospital, and home visits with women in the LC and PNC+LC groups. Descriptive data on infant health visits, and participant/provider experiences will be collected as secondary outcomes. Interviews at 1,3 and 6 months post-partum will collect infant feeding, and health visit data outside the medical center. Medical center visit data will be obtained from MIS data. Primary Outcomes (Hypotheses): Breastfeeding 1. Breastfeeding Intensity at 1,3, and 6 Months 2. Exclusive Breastfeeding at 1,3, and 6 Months Secondary Outcomes (Descriptive): Infant Health, and Participant/Provider Experience 3. To describe the frequency and timing of infant health visits for "breast-feeding sensitive" illnesses 4. To describe participant and provider (LC and PNC) experience of the interventions.

Key facts

Study ID

NCT00619632

Run by

Albert Einstein College of Medicine

People needed

666

Starts

2008-02-01

Expected to finish

2013-02-01

Last updated by the study team

2015-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Enrolled/plan to remain in care at the site throughout their pregnancy
• 1st or 2nd trimester (randomization will include trimester as a blocking factor)
• Aged 18 or older
• Can provide a reliable phone number and at least 2 alternative contacts
• Are carrying a singleton pregnancy
• Can communicate in English or Spanish

You may not qualify if…

• High risk of prematurity/NICU (e.g., ESRD, multiple prior preterms, congenital anomalies)
• Medical/obstetrical complications for which BF is or may be perceived to be contra-indicated (e.g., HIV+, HTLV-1, breast reduction surgery, Hepatitis B and C, pre-gestational diabetes )
• On chronic medications incompatible with BF (e.g., hypoglycemics, lithium, ciprofloxacin)
• Enrolled in site's Group Pre-natal Care (app. 60 women/year)
• Previously enrolled in MILK study
• Craniofacial or neurological conditions that prevent an infant from BF (post-partum exclusion)
• Reported use of street drugs (responds to reviewer comment of how to control for this)

Where it is running

• Comprehensive Family Care Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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