Please select the eligibility criteria that correspond 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: Inclusion Criteria:

Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of \>2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).

No current or recent involvement in other research studies that could potentially affect any of outcome measures.

Mother speaks and understands either English only or English and Malay (some questionnaires are in English)

Exclusion Criteria:

Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.

Mother smokes Mothers who do not exclusively breastfeed their infant

-
B: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
C: Inclusion Criteria:

* Patient in the Maternity Unit at Mount Sinai Hospital
* Infant has a birth weight greater than or equal to 2,500 grams
* Infant has a 5-minute Apgar score greater than or equal to 7
* Self-identifies as Black/African American or Hispanic/Latina; White or minority other than Black/African American or Hispanic/Latina will be referred to a parallel study with the same protocol at Mount Sinai Hospital
* Speaks English or Spanish
* Has a working telephone
D: Inclusion Criteria:

* pregnant women with gestation of 28 weeks or less, making their first antenatal consultation

Exclusion Criteria:

* no exclusion criteria has been developed. All women that qualify are eligible for recruitment

Answer: B