RAND Corporation
Arlington, Virginia, 22202, United States
NCT Number: NCT04856163
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Arlington, Virginia, 22202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will get unlimited access (through 24 weeks postpartum) to video calls with lactation consultants who are available 24/7. Participants can use the service as demanded.
Time frame: 6 months postpartum
Number of participants who report any breastfeeding at 6 months
Time frame: 6 months post-partum
Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)
Time frame: 6 months postpartum
Number of participants who report no formula use at 6 months
Time frame: 6 months postpartum
Breastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale.
RAND
Other
The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial
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