Effect of Antenatal Milk Expression on Breastfeeding Outcomes among Overweight and Obese Women

项目摘要/摘要 这项随机对照试验的目的是检查产前乳汁分泌(AME)的影响。 干预与注意控制条件对未产妇母乳喂养结果的影响 非糖尿病妇女孕前体重指数≥为25。AME涉及牛奶的表达和收集 在妊娠晚期，理论上可以解决母乳喂养的多种障碍 超重和肥胖妇女，包括哺乳自我效能受损、乳汁供应不足(严重- 乳量的内分泌调节)，以及医学背景下的早期配方奶粉补充- 复杂分娩(可获得库存的产前乳汁)。尽管AME在美国以外的地方越来越受欢迎， 缺乏证据支持它在有或没有风险因素的妇女中广泛采用 对于不良的母乳喂养结果。在这项拟议的研究中，参与者将在34-366/7孕期登记 几周，并被分配到以下两个学习分支之一：1)由Remote，Live International提供的AME指导 董事会认证的哺乳顾问通过创新的基于APP的远程哺乳平台在我们之前的 研究；或2)注意力控制条件(与婴儿喂养无关的基于视频的婴儿护理教育)。 AME指导或对照组视频教育将在37至40周的每周研究访问中进行 妊娠期，干预组妇女每天在家中继续进行1-2次AME。具体目标是 1)确定AME干预对短期母乳喂养结果的影响，包括 母乳喂养的自我效能感和排他性，到产后两周；2)探讨母乳喂养的持续效果 AME干预较长时间的母乳喂养持续时间和产后第一年的排他性；以及3) 考察参与者对AME的体验和认知。AIMS 1和AIMS 2的数据将通过 登记时的病历审查、面对面和远程调查完成以及产后随访 产后2周、6周、12周、6个月、12个月。对于目标3，母亲对 而AME的经历将在产后6周通过深入采访获得。使用意图- 治疗方法、广义线性混合效应模型和COX比例风险回归 用于检验治疗分配(AME与对照)对量化结果的影响。敏感度 将进行分析，以确定AME的接收和“剂量”对结果的影响。我们还将探索其角色 母亲对牛奶供应的感知和产乳第二阶段的开始(在接下来的几天里大量产奶 出生)在后临时调解分析中。这个项目利用了我们研究团队正在进行的研究调查 AME在正常体重和超重/肥胖母亲中应用的可行性和初步疗效 远程哺乳提供母乳喂养支持的可行性。结果将为临床实践和政策提供参考 关于对超重和肥胖妇女的循证母乳喂养支持。

PROJECT SUMMARY/ABSTRACT The purpose of this randomized controlled trial is to examine the impact of an antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among overweight and obese women, including impaired breastfeeding self-efficacy, insufficient milk supply (critical- period endocrine modulation of milk volume), and early formula supplementation in the context of a medically- complex birth (availability of banked antenatal milk). Although AME is increasing in popularity outside the U.S., there is a lack of evidence to support its widespread adoption among women both with and without risk factors for poor breastfeeding outcomes. In the proposed study, participants will be enrolled at 34-366/7 gestational weeks and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform trialed in our previous research; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). AME instruction or control group video education will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Specific aims are to: 1) determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum; 2) to explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum; and 3) to examine participants’ experiences with and perceptions of AME. Data for Aims 1 and 2 will be captured via medical record review and in-person and remote survey completion at enrollment and postpartum follow-ups at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postpartum. For Aim 3, maternal perceptions about and experiences with AME will be captured via in-depth interviews at 6 weeks postpartum. Using an intention- to-treat approach, generalized linear mixed-effects modeling and Cox proportional hazards regression will be used to examine the effect of treatment assignment (AME vs. control) on quantitative outcomes. Sensitivity analyses will be conducted to determine receipt and “dose” of AME on outcomes. We will also explore the role of maternal perception of milk supply and onset of lactogenesis II (copious milk production in the days following birth) in post-hoc mediational analyses. This project leverages our study team’s ongoing research investigating feasibility and preliminary efficacy of AME among normal weight and overweight/obese first-time mothers and feasibility of telelactation-delivered breastfeeding support. Results will inform clinical practice and policy regarding evidence-based breastfeeding support for overweight and obese women.