Skip to main content
OpenTrials
Completed

NCT Number: NCT02870413

Expanding Rural Access to Breastfeeding Support Via Telehealth: The Tele-MILC Trial

The investigators will conduct a randomized controlled trial (RCT) to generate data on the impact of direct-to-consumer "telelactation" (virtual breastfeeding support) services. We will explore the feasibility, acceptability, and impact of these services. Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into two study arms: 1) outpatient telelactation services via video calls on personal devices or 2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and satisfaction with breastfeeding, will be captured via surveys and in-depth interviews and compared across groups.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RAND Corporation

Arlington, Virginia, 22202, United States

About this study

Increasing breastfeeding rates is an ongoing public health priority because of the health and economic benefits for infants, mothers, and communities. Professional lactation support, specifically by International Board Certified Lactation Consultants (IBCLCs), increases breastfeeding duration and exclusivity. Rural and underserved mothers have lower breastfeeding rates, and limited access to professional lactation support may contribute to this disparity. As such, the Surgeon General identifies increasing access to IBCLCs as a policy priority. Virtual "telelactation" consults that use two-way video have the potential to increase access to IBCLC services in rural settings that lack them. Several companies have begun to offer telelactation through a direct-to-consumer (DTC) model, where patients initiate video calls with providers using their personal devices including mobile phones, tablets, and laptops. While four studies with small samples explored the use of antiquated videoconferencing technology (i.e., that required dedicated equipment) for lactation support, no research has studied DTC telelactation or linked telelactation with breastfeeding outcomes. To address this evidence gap, the investigators will conduct a randomized controlled trial (RCT) to generate data on the feasibility, acceptability, and impact of DTC telelactation services. Postpartum mothers age 18 and older who have initiated breastfeeding will be recruited at a critical access hospital without access to IBCLCs in rural Pennsylvania and randomized into two study arms: 1) outpatient telelactation services via video calls on personal devices or 2) usual care. Data on breastfeeding duration and exclusivity, as well as perceptions and satisfaction with breastfeeding and with telelactation services, will be captured via surveys and in-depth interviews and compared across groups. This study will be the first experimental evaluation of telelactation and the first ever evaluation of DTC telelactation services. The results will inform policy debates about reimbursement and regulation of DTC telehealth services and the strengths and limitations of this model of healthcare delivery as applied to breastfeeding. It also has the potential to promote breastfeeding, one of the most widely recommended health behaviors among underserved families, and improve children's health in rural settings.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for mothers:

  • ≥ 18 years;
  • Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge
  • Fluent in English

Inclusion criteria

for infants:

  • Infants must be term or near term (>35 weeks gestational age)
  • Not require a stay in the neonatal intensive care unit

Exclusion criteria

  • Prisoners, incarcerated individuals, detainees, parolees, probationers will be excluded because there may external circumstances outside of their control that may prevent continuous breastfeeding.
  • Mothers and infants will be excluded if they have maternal, fetal, or neonatal conditions or complications with the potential to physiologically compromise breastfeeding or milk supply (e.g., infant cardiac defects, post-partum infant ventilator dependence), and or contraindications to breastfeeding as specified by the American Academy of Pediatrics (e.g., HIV+ status).

Treatment and study plan

Telelactation services

Behavioral

Mothers will get unlimited access (for a three month period) to video calls with lactation consultants who are available 24/7. Mothers can use the service as demanded.

Other names: Virtual/remote breastfeeding support

Primary outcomes

  1. Any breastfeeding (yes/no) at 3 months

    Time frame: Three months

  2. Exclusive breastfeeding (yes/no) at 3 months

    Time frame: Three months

Secondary outcomes

  1. Breastfeeding satisfaction (self-reported via questionnaire at 3 months postpartum)

    Time frame: Three months

    Survey question which captures extent of satisfaction with the experience of breastfeeding. Question reads: How satisfied do you feel about the experience of breastfeeding your baby over the past three months? (Very unsatisfied, somewhat unsatisfied, neither unsatisfied nor satisfied, somewhat satisfied, very satisfied). We will create a binary variable (satisfied vs. unsatisfied) based on this response, with those reporting "somewhat satisfied" or "very satisfied" defined as "satisfied."

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
Oct 3, 2019

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.

Published trials that share one or more normalized conditions with this study.