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

基本信息

批准号：
7620948
负责人：
KAREN A. BONUCK
金额：
$ 65.14万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2012-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7620948
关键词：
Abbreviations Academy Advisory Committees American Awareness Birth Breast Feeding Caring 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 clinical practice college design ear infection effective intervention evidence base experience feeding gastrointestinal infant nutrition intervention effect meetings obesity in children prenatal primary outcome provider intervention respiratory routine provider secondary outcome standard care standard of care therapy design

项目摘要

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，以评估低收入多民族女性长达 6 个月的母乳喂养 (BF) 强度，并按外国出生进行分层。来自布朗克斯大型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 将在整个怀孕期间对 PNC 和 PNC+LC 组的女性使用简短的电子提示方案。该中心的研究 LC 将为 LC 和 PNC+LC 组的女性进行个性化的产前检查、医院和家访以及电话支持。主要结果：四个治疗组之间的母乳喂养差异 1) 1,3 和 6 个月时的母乳喂养强度 - 通过 7 天回忆母乳/其他液体 + 固体进行评估。 2) 第 1、3 和 6 个月时的纯母乳喂养 - 评估如上所述。次要结果（描述性）：婴儿健康以及参与者和提供者体验 3) 按治疗组描述婴儿医疗保健的使用情况。 4) 按 BF 强度描述婴儿保健的使用，无论分组如何。 5) 描述参与者和提供者的干预体验。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进行此类试验的呼吁，并分析了联合干预措施的独特和协同效应。全国 BF 意识运动的信息——通过 6 个月的 BF 来减少婴儿疾病——将得到应用。这应该会产生更大的 BF 强度，从而朝着提议的 Healthy People 2010 专属 BF 目标取得进展。该设计与我们最近单独进行 LC 干预的试验不同，但建立在其基础之上。产后 1、3 和 6 个月的访谈将评估婴儿喂养、婴儿疾病和婴儿医疗就诊。将收集婴儿医疗中心的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）增加了将有效干预措施转化为实践的可能性。