The Impact of Telelactation Services on Breastfeeding Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Behavioral: Telelactation support

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.

• Study Type: Interventional
• Enrollment (Actual): 2109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Arlington, Virginia, United States, 22202
      • RAND Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: ebook; Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration 1	Any breastfeeding (yes/no) at 6 months	6 months postpartum
Breastfeeding duration 2	Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)	6 months post-partum
Breastfeeding exclusivity	No formula use in the prior 24 hours (yes/no) at 6 months	6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding satisfaction	Breastfeeding satisfaction (self-reported via questionnaire at 6 months postpartum). Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the H&H lactation scale).	6 months postpartum
Experiences with telelactation	Qualitative data from semi-structured interviews on experiences with telelactation	8 weeks postpartum

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; breastfeeding; telehealth; disparities; health equity
• Other Study ID Numbers: R01NR018837 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data resulting from the proposed research will be shared with external researchers who request access beginning one year after the project ends. Results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in exploring approaches to improving breastfeeding rates following a brief application process. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the principal investigator and co-investigators, as required by NIH's data sharing policy.
• IPD Sharing Time Frame: 2025-2028
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No