The Impact of Telelactation Services on Breastfeeding Outcomes

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04856163
• Other study ID #: R01NR018837
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2109
• Est. completion date: July 31, 2025
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
United States	RAND Corporation	Arlington	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
RAND	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding duration 1	Any breastfeeding (yes/no) at 6 months	6 months postpartum
Primary	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
Primary	Breastfeeding exclusivity	No formula use in the prior 24 hours (yes/no) at 6 months	6 months postpartum
Secondary	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
Secondary	Experiences with telelactation	Qualitative data from semi-structured interviews on experiences with telelactation	8 weeks postpartum