Clinical trial NCT04856163: The Impact of Telelactation Services on Breastfeeding Outcomes
Official title: The Impact of Telelactation Services on Breastfeeding Outcomes: Digital Tele-MILC Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: telehealth
telemedicine
health equity
disparities
breastfeeding
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2021-04-23
Enrollment: 2108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Breastfeeding Duration 1
timeFrame: 6 months postpartum
measure: Breastfeeding Duration 2
timeFrame: 6 months post-partum
measure: Breastfeeding Exclusivity
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Breastfeeding Satisfaction
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Arlington
country: United States
facility: RAND Corporation
state: Virginia
Study officials:
References:
citation: Uscher-Pines L, Demirci J, Waymouth M, Lawrence R, Parks A, Mehrotra A, Ray K, DeYoreo M, Kapinos K. Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial. Trials. 2022 Jan 3;23(1):5. doi: 10.1186/s13063-021-05846-w.