Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Boosting Breastfeeding in Low-Income, Multi-ethnic Women: A Primary Care Based RCT
Brief Summary: 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.


Options:
A: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Relaxation; Type: EXPERIMENTAL; Interventions: Behavioral: Relaxation | Intervention Type: BEHAVIORAL; Name: Relaxation; Assigned to Arm(s): Relaxation
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Lactation Consultant | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Provider Prompt | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Behavioral: LC+ Provider Prompt | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lactation Consultant; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Provider Prompt; Assigned to Arm(s): 2 | Intervention Type: BEHAVIORAL; Name: LC+ Provider Prompt; Assigned to Arm(s): 3
C: Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Behavioral education; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral education intervention | Intervention Type: BEHAVIORAL; Name: Behavioral education intervention; Assigned to Arm(s): Behavioral education
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Community Health Workers; Type: EXPERIMENTAL; Interventions: Behavioral: community health workers | Intervention Type: BEHAVIORAL; Name: community health workers; Assigned to Arm(s): Community Health Workers

Answer: B