The Impact of Telelactation Services on Breastfeeding Outcomes

RanD

Status: Completed

Conditions: Breastfeeding

Treatments: Behavioral: Telelactation support

Study type: Interventional

Funder types: Other

Identifiers

NCT04856163

R01NR018837

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,108 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,108 participants in 2 patient groups

Telelactation support

Experimental group

Description:

Participants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services will be available through mobile phone app.

Treatment:

Behavioral: Telelactation support

ebook

No Intervention group

Description:

Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care.