NCT02870413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

August 10, 2016

Last Update Submit

October 1, 2019

Conditions

Breastfeeding

Keywords

telehealth

Outcome Measures

Primary Outcomes (2)

  • Any breastfeeding (yes/no) at 3 months

    Three months

  • Exclusive breastfeeding (yes/no) at 3 months

    Three months

Secondary Outcomes (1)

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

    Three months

Study Arms (2)

Telelactation support

EXPERIMENTAL

Participants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 12 weeks post-partum. Services will be available through mobile phone app.

Behavioral: Telelactation services

Usual care

NO INTERVENTION

Participants in the control arm will receive care as usual.

Interventions

Telelactation servicesBEHAVIORAL

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.

Also known as: Virtual/remote breastfeeding support
Telelactation support

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≥ 18 years;
  • Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge
  • Fluent in English
  • Infants must be term or near term (\>35 weeks gestational age)
  • Not require a stay in the neonatal intensive care unit

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAND Corporation

Arlington, Virginia, 22202, United States

Location

Related Publications (2)

  • Uscher-Pines L, Ghosh-Dastidar B, Bogen DL, Ray KN, Demirci JR, Mehrotra A, Kapinos KA. Feasibility and Effectiveness of Telelactation Among Rural Breastfeeding Women. Acad Pediatr. 2020 Jul;20(5):652-659. doi: 10.1016/j.acap.2019.10.008. Epub 2019 Oct 16.

    PMID: 31629118DERIVED

  • Kapinos K, Kotzias V, Bogen D, Ray K, Demirci J, Rigas MA, Uscher-Pines L. The Use of and Experiences With Telelactation Among Rural Breastfeeding Mothers: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 3;21(9):e13967. doi: 10.2196/13967.

    PMID: 31482848DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Policy Researcher

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 17, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)