The Impact of Telelactation Services on Breastfeeding Outcomes

NCT ID: NCT04856163

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2023-12-31

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Telelactation support

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.

Group Type: EXPERIMENTAL

Telelactation support

Intervention Type: BEHAVIORAL

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.

ebook

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telelactation support

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RAND Corporation

Arlington, Virginia, United States

Countries

United States

References

Uscher-Pines L, Kapinos K, Waymouth M, Howell K, Alvarado G, Ray K, Demirci J, Mehrotra A, Rogers R, James KF, DeYoreo M. Telelactation Services and Breastfeeding by Race and Ethnicity: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461958. doi: 10.1001/jamanetworkopen.2024.61958.

Reference Type: DERIVED

PMID: 40014345 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34980212 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01NR018837

Identifier Type: NIH

Identifier Source: org_study_id

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