Breastfeeding, Exclusive clinical trials

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

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.