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Completed

NCT Number: NCT04856163

The Impact of Telelactation Services on Breastfeeding Outcomes

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RAND Corporation

Arlington, Virginia, 22202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telelactation support

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.

Primary outcomes

  1. Breastfeeding Duration 1

    Time frame: 6 months postpartum

    Number of participants who report any breastfeeding at 6 months

  2. Breastfeeding Duration 2

    Time frame: 6 months post-partum

    Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)

  3. Breastfeeding Exclusivity

    Time frame: 6 months postpartum

    Number of participants who report no formula use at 6 months

Secondary outcomes

  1. Breastfeeding Satisfaction

    Time frame: 6 months postpartum

    Breastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale.

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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