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

项目概要/摘要 这项随机对照试验的目的是检查产前乳汁分泌（AME） 干预与注意力控制条件对母乳喂养结果之间的样本未经产， 孕前体重指数≥ 25的非糖尿病女性。AME涉及乳汁表达和收集 在怀孕的第三个三个月，理论上是为了解决母乳喂养的多重障碍， 超重和肥胖妇女，包括母乳喂养自我效能受损，牛奶供应不足（关键- 奶量的内分泌调节），以及在医学上- 复杂分娩（产前母乳库存的可用性）。尽管AME在美国以外的地区越来越受欢迎， 缺乏证据支持它在有和没有风险因素的妇女中广泛采用 母乳喂养效果不佳。在拟定的研究中，受试者将在妊娠34 - 366/7时入组 1）AME指令由远程、现场的国际教育机构提供， 董事会认证的哺乳顾问通过一个创新的基于应用程序的远程哺乳平台在我们以前的试验 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 - 40周的每周研究访视中进行 干预组的妇女在家中每天继续AME 1 - 2次。具体的目标是 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，以产后两周为研究对象; 2）探讨母乳喂养的持续效果 AME干预产后第一年的长期母乳喂养持续时间和排他性;以及3） 检查参与者对AME的体验和看法。目标1和目标2的数据将通过 在入组和产后随访时进行病历审查以及亲自和远程调查 产后2周、6周、12周、6个月和12个月。对于目标3，母亲对 和经验与AME将通过深入访谈，在产后6周捕获。利用意图- 治疗方法、广义线性混合效应模型和考克斯比例风险回归将 用于检查治疗分配（AME与对照）对定量结局的影响。灵敏度 将进行分析以确定AME的接受和"剂量"对结果的影响。我们还将探讨 母亲对乳汁供应的感知和乳汁生成II的开始（在随后的几天内大量产奶） 出生）在事后中介分析中。这个项目利用了我们研究小组正在进行的研究， AME在正常体重和超重/肥胖的第一次母亲中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。结果将告知临床实践和政策 关于为超重和肥胖妇女提供基于证据的母乳喂养支持。

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.