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

描述(申请人提供)：我们将进行一项随机、对照、单中心、单盲、2x2析因设计试验，以评估低收入多民族妇女6个月内的母乳喂养强度，按外国出生进行分层。来自大型布朗克斯健康中心的产前患者将被随机分为四个治疗组之一：(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将在怀孕期间与PNC和PNC LC组的妇女使用简短的电子提示方案。该中心的LCS研究将进行个性化的产前治疗、医院和家访，并与LC组和PNC LC组的妇女提供电话支持。主要结果：四个治疗组之间的母乳喂养差异1)1、3和6个月的母乳喂养强度-通过7天回忆母乳/其他液体固体来评估。2)1个月、3个月和6个月时纯母乳喂养--如上评估。次要结果(描述性)：婴儿健康，以及参与者和提供者的经历3)按治疗组描述婴儿保健使用情况。4)不分组别，按BF强度描述婴儿保健使用情况。5)描述干预的参与者和提供者的体验。这是美国第一个评估常规提供者、以初级保健为基础的BF干预的试验。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的独特和协同影响的试验。全国BF意识运动的信息-减少婴儿疾病与6个月独家BF-将被应用。这应该会产生更大的高炉强度，从而朝着拟议的健康人2010年独家高炉目标取得进展。该设计不同于我们最近单独进行的LC干预试验，但建立在此基础上。产后1、3和6个月的访谈将评估婴儿喂养、婴儿疾病和婴儿就医情况。将收集婴儿医疗中心的管理信息系统数据。来自围产期护理、医生和哺乳专家小组(美国护士助产士学会、美国妇产科学会、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.