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

描述（由申请人提供）：我们将进行一项随机、对照、单中心、单盲、2x2因子设计试验，以外国出生的低收入多民族妇女为分层，评估母乳喂养（BF）强度至6个月。来自布朗克斯一家大型保健中心的产前病人将被随机分为四个治疗组：(a)产前护理提供者（PNC）；(b)哺乳顾问（LC）；(c) PNC+LC或；(d)控制护理标准。PNC将对PNC组和PNC+LC组的妇女在整个孕期使用一份简短的电子提示协议。中心的研究LC将对LC组和PNC+LC组的妇女进行个性化的产前会议、医院和家访以及电话支持。1) 1,3和6个月时的母乳喂养强度-通过母乳/其他液体+固体的7天召回来评估。2) 1、3、6个月纯母乳喂养——如上所述。次要结局（描述性）：婴儿健康，参与者和提供者经验3)按治疗组描述婴儿保健使用情况。4)在不考虑分组分配的情况下，通过BF强度描述婴儿保健使用情况。5)描述干预措施的参与者和提供者的经验。这是美国第一个评估常规提供者、基于初级保健的BF干预措施的试验。因此，它响应了美国预防服务工作组对此类试验的呼吁，以及那些分析联合干预措施的独特和协同效应的试验。全国提高BF意识运动的信息——减少6个月的独家BF婴儿疾病——将适用。这将产生更大的BF强度，从而朝着拟议的健康人2010专属BF目标迈进。设计不同于，但建立在我们最近单独的LC干预试验的基础上。产后1、3和6个月的访谈将评估婴儿喂养、婴儿疾病和婴儿就诊情况。将收集婴儿医疗中心MIS数据。围产期护理、内科医生和哺乳专家团体（美国护士助产士学院、美国妇产科学院、美国儿科学会等）的热情支持（见信件）增加了有效干预措施转化为实践的可能性。

DESCRIPTION (provided by applicant): We will conduct a randomized, controlled, single-center, single-blind, 2x2 factorial design trial to assess breastfeeding (BF) intensity up to 6 months in low-income multiethnic women, stratifying by foreign birth. Prenatal patients from a large Bronx health center will be randomized into one of four treatment groups: (a) Prenatal Care Provider (PNC); (b) Lactation Consultant (LC); (c) PNC+LC, or; (d) Control standard of care. PNCs will use a brief, electronically prompted protocol with women in the PNC and PNC+LC groups throughout pregnancy. Study LCs at the center will conduct individualized pre-natal sessions, hospital and home visits, and phone support with women in the LC and PNC+LC groups. Primary Outcomes: Breastfeeding Differences Among Four Treatment Groups 1) Breastfeeding Intensity at 1,3, and 6 Months- assessed via 7 day recall of breastmilk/other liquid + solids. 2) Exclusive Breastfeeding at 1, 3, and 6 Months- assessed as above. Secondary Outcomes (Descriptive): Infant Health, and Participant & Provider Experiences 3) To describe infant health care use, by treatment group. 4) To describe infant health care use by intensity of BF, regardless of group assignment. 5) To describe participant and provider experience of the interventions. This is the first US trial to assess routine provider, primary-care based BF interventions. Thus, it responds to the US Preventive Services Task Force call for such trials, and, those analyzing the unique and synergistic effects of combined interventions. The National BF Awareness Campaign message-reduced infant illness with 6 months exclusive BF- will be applied. This should yield greater BF intensity, and thus progress towards proposed Healthy People 2010 exclusive BF goals. The design differs from, but builds upon our recent trial of an LC intervention alone. Interviews at 1,3, and 6 months post-partum will assess infant feeding, infant illness, and infant medical visits. Infant's medical center MIS data will be collected. Enthusiastic support (see letters) from perinatal nursing, physician, and lactation specialist groups (American College of Nurse Midwives, American College of Obstetrics & Gynecology, American Academy of Pediatrics, and others) increases the likelihood that effective interventions will be translated into practice.