MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers

NCT06520696 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-07-26

No results posted yet for this study

Summary

The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF behaviors in low-income Hispanic women. Formative research conducted for the development of MILC and results from pilot testing will help guide the completion of the development and testing of this prototype that specifically caters to Hispanic women. In the long term, MILC has the potential to increase the rates of EBF and any BF up to 12 months.

Conditions

  • Breastfeeding, Exclusive

Interventions

BEHAVIORAL

MILC application

Eligible Hispanic participants in their third trimester will be recruited for the study. Intervention group will receive standard WIC services plus the MILC application. Standard WIC support includes on-site lactation consultation, bilingual peer counseling, weekly peer support meetings, free breast pump, and enhanced food package for BF mothers. If a participant has trouble with breastfeeding, she will be referred to a home-visiting breastfeeding peer counselor in the area. Participants will be asked to participate in the periodic follow-up assessments at 1, 3 and 6 months along with demonstrating breastfeeding via MILC app. Participants will send in 1 BF video per month using the MILC app to verify continued BF and fill out monthly self-report to verify EBF. Participants in the incentive group will receive escalating monthly points as incentives for every additional month of continued BF and EBF.

BEHAVIORAL

Usual care

Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program and will be asked to participate in the periodic follow-up assessments at 1, 3 and 6 months. Participants in the control group can receive financial compensation for the completion of assessments. This is necessary to maximize retention and adherence to the monthly assessment schedule, provide comparable remuneration as the incentive group, and minimize demoralization of control group participants following treatment assignment. All participants are informed of the differential group procedures during the randomization consent process. In addition to the follow-up assessment, control group will also complete a monthly self-report on BF status (both for EBF and "any BF"). For attention control purposes in this group, participants will be referred to a mobile app for tracking the baby's milestones called Baby Connect.

Sponsors & Collaborators

  • RTI International

    collaborator OTHER
  • Temple University

    collaborator OTHER
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • UConn Health

    collaborator OTHER
  • Benten Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Tony Ma, MS · Benten Technologies

  • Yukiko Washio, PhD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-02-28
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520696 on ClinicalTrials.gov