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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870413
Enrollment
203
Registered
2016-08-17
Start date
2016-10-31
Completion date
2018-07-31
Last updated
2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

telehealth

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALTelelactation services

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.

Sponsors

University of Pittsburgh
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 46 Years
Healthy volunteers
Yes

Inclusion criteria

for mothers: 1. ≥ 18 years; 2. Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge 3. Fluent in English Inclusion criteria for infants: 1. Infants must be term or near term (\>35 weeks gestational age) 2. Not require a stay in the neonatal intensive care unit

Exclusion criteria

1. Prisoners, incarcerated individuals, detainees, parolees, probationers will be excluded because there may external circumstances outside of their control that may prevent continuous breastfeeding. 2. 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).

Design outcomes

Primary

MeasureTime frame
Any breastfeeding (yes/no) at 3 monthsThree months
Exclusive breastfeeding (yes/no) at 3 monthsThree months

Secondary

MeasureTime frameDescription
Breastfeeding satisfaction (self-reported via questionnaire at 3 months postpartum)Three monthsSurvey 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026