NCT04856163

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,108

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

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

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

April 19, 2021

Results QC Date

November 15, 2024

Last Update Submit

December 11, 2024

Conditions

Breastfeeding

Keywords

telehealthtelemedicinehealth equitydisparitiesbreastfeeding

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Duration 1

    Number of participants who report any breastfeeding at 6 months

    6 months postpartum

  • 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

  • Breastfeeding Exclusivity

    Number of participants who report no formula use at 6 months

    6 months postpartum

Secondary Outcomes (1)

  • Breastfeeding Satisfaction

    6 months postpartum

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 24 weeks post-partum. Services will be available through mobile phone app.

Behavioral: Telelactation support

ebook

NO INTERVENTION

Participants in the control arm will receive care as usual. They will also receive a ebook with content on infant care.

Interventions

Telelactation supportBEHAVIORAL

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.

Telelactation support

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≥ 18 years of age
  • pregnant with first child
  • intend to attempt breastfeeding
  • residing in a state underserved by IBCLCs

You may not qualify if:

  • 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)

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, Kapinos K, Waymouth M, Howell K, Alvarado G, Ray K, Demirci J, Mehrotra A, Rogers R, James KF, DeYoreo M. Telelactation Services and Breastfeeding by Race and Ethnicity: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461958. doi: 10.1001/jamanetworkopen.2024.61958.

    PMID: 40014345DERIVED

  • Uscher-Pines L, Demirci J, Waymouth M, Lawrence R, Parks A, Mehrotra A, Ray K, DeYoreo M, Kapinos K. Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial. Trials. 2022 Jan 3;23(1):5. doi: 10.1186/s13063-021-05846-w.

    PMID: 34980212DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Limitations and Caveats

Generalizability: Digital trials may not reach individuals without reliable access to technology and digital literacy; Inclusion criteria: We were not able to assess the impact of telelactation on breastfeeding initiation because we only enrolled individuals who intended to breastfeed; Outcomes were self-reported.

Results Point of Contact

Title
Dr. Lori Uscher-Pines
Organization
RAND
luscherp@rand.org
703-413-1100

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

July 8, 2021

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

January 3, 2025

Results First Posted

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Data resulting from the proposed research will be shared with external researchers who request access beginning one year after the project ends. Results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in exploring approaches to improving breastfeeding rates following a brief application process. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the principal investigator and co-investigators, as required by NIH's data sharing policy.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2025-2028

Locations

US(1)