RAND Corporation, 1200 S Hayes St, Arlington, VA, 22202, USA.
University of Pittsburgh School of Nursing, 3500 Victoria Street, Pittsburgh, PA, 15261, USA.
Trials. 2022 Jan 3;23(1):5. doi: 10.1186/s13063-021-05846-w.
Breastfeeding offers many medical and neurodevelopmental advantages for birthing parents and infants; however, the majority of parents stop breastfeeding before it is recommended. Professional lactation support by the International Board Certified Lactation Consultants (IBCLCs) increases breastfeeding rates; however, many communities lack access to IBCLCs. Black and Latinx parents have lower breastfeeding rates, and limited access to professional lactation support may contribute to this disparity. Virtual "telelactation" consults that use two-way video have the potential to increase access to IBCLCs among disadvantaged populations. We present a protocol for the digital Tele-MILC trial, which uses mixed methods to evaluate the impact of telelactation services on breastfeeding outcomes. The objective of this pragmatic, parallel design randomized controlled trial is to assess the impact of telelactation on breastfeeding duration and exclusivity and explore how acceptability of and experiences with telelactation vary across Latinx, Black, and non-Black and non-Latinx parents to guide future improvement of these services.
2400 primiparous, pregnant individuals age > 18 who intend to breastfeed and live in the USA underserved by IBCLCs will be recruited. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by over one million pregnant individuals in the USA annually. Participants will be randomized to (1) on-demand telelactation video calls on personal devices or (2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for 8 months (including 6 months postpartum). Primary outcomes include breastfeeding duration and breastfeeding exclusivity. We will quantify differences in these outcomes across racial and ethnic groups. Both intention-to-treat and as-treated (using instrumental variable methods) analyses will be performed. This study will also generate qualitative data on the experiences of different subgroups of parents with the telelactation intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.
This is the first randomized study evaluating the impact of telelactation on breastfeeding outcomes. It will inform the design and implementation of future digital trials among pregnant and postpartum people, including Black and Latinx populations which are historically underrepresented in clinical trials.
ClinicalTrials.gov NCT04856163. Registered on April 23, 2021.
母乳喂养为分娩父母和婴儿带来许多医学和神经发育方面的益处；然而，大多数父母在推荐的时间之前就停止了母乳喂养。国际认证哺乳顾问（IBCLC）的专业哺乳支持可提高母乳喂养率；然而，许多社区都无法获得 IBCLC 的支持。黑人和拉丁裔父母的母乳喂养率较低，而获得专业哺乳支持的机会有限可能是造成这种差异的原因之一。使用双向视频的虚拟“远程哺乳咨询”有潜力增加弱势人群获得 IBCLC 的机会。我们提出了一项数字 Tele-MILC 试验的方案，该方案采用混合方法评估远程哺乳服务对母乳喂养结果的影响。这项实用、平行设计的随机对照试验的目的是评估远程哺乳对母乳喂养持续时间和排他性的影响，并探讨远程哺乳的可接受性和体验在拉丁裔、黑人和非黑人和非拉丁裔父母之间的差异，以指导这些服务的未来改进。
将招募 2400 名年龄在 18 岁以上、初次怀孕、打算母乳喂养且居住在美国 IBCLC 服务不足地区的孕妇。招募将通过 Ovia 进行，Ovia 是一款怀孕追踪手机应用程序，在美国每年有超过 100 万孕妇使用。参与者将随机分配到（1）按需远程哺乳视频电话（在个人设备上）或（2）婴儿护理电子书/常规护理。母乳喂养结果将通过调查和访谈进行收集，并在不同种族和族裔群体之间进行比较。这项研究将跟踪参与者 8 个月（包括产后 6 个月）。主要结果包括母乳喂养持续时间和母乳喂养排他性。我们将量化这些结果在不同种族和族裔群体之间的差异。将进行意向治疗和（使用工具变量方法）治疗分析。这项研究还将生成关于不同亚组父母对远程哺乳干预的体验的定性数据，包括使用障碍、满意度以及这种交付模式的优势和局限性。
这是第一项评估远程哺乳对母乳喂养结果影响的随机研究。它将为未来在孕妇和产后人群中进行数字试验的设计和实施提供信息，包括在临床试验中历来代表性不足的黑人和拉丁裔人群。
ClinicalTrials.gov NCT04856163。2021 年 4 月 23 日注册。
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