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临床试验/NCT04856163
NCT04856163已完成不适用

The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial

RAND2 个研究点 分布在 1 个国家目标入组 2,108 人开始时间: 2021年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
2,108
试验地点
2
主要终点
Breastfeeding Duration 1

研究概览

简要总结

This project will assess the impact of a novel breastfeeding support intervention ("telelactation"), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.

详细描述

This study is a pragmatic, parallel design randomized controlled trial that will generate evidence on the impact of telelactation on breastfeeding duration and exclusivity and explore differences in effectiveness by race/ethnicity. The study is mixed methods, and uses a sequential explanatory design in which qualitative interviews are used to explain and contextualize findings from the quantitative outcomes analysis. We will recruit primiparous, pregnant individuals age > 18 who intend to breastfeed and live in states most underserved by IBCLCs. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by one million pregnant individuals in the U.S. 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 eight months (including six months postpartum), generating 1) quantitative data on the impact of telelactation and differences in effectiveness across racial and ethnic minority groups; and 2) rich qualitative data on the experiences of different subgroups of parents with the intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 18 years of age
  • pregnant with first child
  • intend to attempt breastfeeding
  • residing in a state underserved by IBCLCs

排除标准

  • non-singleton pregnancy
  • advised by healthcare provider not to breastfeed for a medical reason (e.g., HIV+ status, chemotherapy planned)
  • in police custody or incarcerated
  • infant to be separated from birthing parent (e.g., given up for adoption, military deployment)

结局指标

主要结局

Breastfeeding Duration 1

时间窗: 6 months postpartum

Number of participants who report any breastfeeding at 6 months

Breastfeeding Duration 2

时间窗: 6 months post-partum

Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)

Breastfeeding Exclusivity

时间窗: 6 months postpartum

Number of participants who report no formula use at 6 months

次要结局

  • Breastfeeding Satisfaction(6 months postpartum)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (2)

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