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

促进低收入、多种族妇女的母乳喂养：基于初级保健的随机对照试验

• 批准号: 8082713
• 负责人: KAREN A. BONUCK
• 金额: $ 50.37万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8082713
• 关键词: Abbreviations; Academy; Advisory Committees; American; Awareness; Birth; Breast Feeding; Caring; Childhood; Clinical Trials Design; Clinics and Hospitals; Control Groups; Country; Data; Diarrhea; Discipline of obstetrics; Exclusive Breastfeeding; Foundations; Frequencies; Goals; Government; Gynecology; Health; Healthy People 2010; Home environment; Home visitation; Hospitals; House Call; Infant; Infant Care; Infant Health; International; Intervention; Interview; Lactation; Letters; Liquid substance; Low income; Medical; Medical center; Mullerian duct inhibiting substance; Nurse Midwives; Outcome; Participant; Patients; Pediatrics; Perinatal Nursing; Physicians; Pregnancy; Prenatal care; Preventive; Primary Health Care; Protocols documentation; Provider; Randomized; Research Personnel; Respiratory Tract Infections; Services; Solid; Specialist; Stratification; Telephone; Testing; Time; Translating; Treatment outcome; United States National Institutes of Health; Visit; Woman; base; blind; clinical practice; college; design; ear infection; effective intervention; evidence base; experience; feeding; gastrointestinal; infant nutrition; intervention effect; meetings; prenatal; primary outcome; provider intervention; respiratory; routine provider; secondary outcome; standard care; standard of care; therapy design

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.

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析因设计试验，以评估低收入多种族妇女长达6个月的母乳喂养（BF）强度，按外国出生分层。将来自大型布朗克斯卫生中心的产前患者随机分配至4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）对照标准护理。PNC将在整个妊娠期间对PNC和PNC+LC组的女性使用简短的电子提示方案。中心的研究LC将进行个性化的产前课程，医院和家庭访视，并与LC和PNC+LC组的女性进行电话支持。主要结局：四个治疗组之间的母乳喂养差异1）1、3和6个月时的母乳喂养强度-通过7天母乳/其他液体+固体的回忆进行评估。2)1、3和6个月时的纯母乳喂养-如上所述进行评估。次要结果（描述性）：婴儿健康，以及参与者和提供者的经验3）描述婴儿医疗保健的使用，按治疗组。4)按BF强度描述婴儿医疗保健使用情况，不考虑组分配。5)描述参与者和提供者的干预经验。这是第一个美国试验，以评估常规提供者，初级保健为基础的BF干预。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作用的试验。国家BF意识运动的消息减少婴儿疾病与6个月的专属BF-将被应用。这将产生更大的BF强度，从而朝着拟议的2010年健康人群专属BF目标取得进展。该设计不同于，但建立在我们最近单独进行LC干预试验的基础上。在产后1、3和6个月的访谈将评估婴儿喂养、婴儿疾病和婴儿医疗访视。将收集婴儿医疗中心MIS数据。来自围产期护理、医生和哺乳专家团体（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。