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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856163
Other study ID # R01NR018837
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 8, 2021
Est. completion date December 31, 2023

Study information

Verified date April 2024
Source RAND
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 2109
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
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)

Study Design


Related Conditions & MeSH terms


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
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