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

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Benten Technologies, Inc.
Study ID
NCT06520696
Status
Not Yet Recruiting

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Conditions

  • Breastfeeding, Exclusive

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • MILC application — BEHAVIORAL
    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.
  • Usual care — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Jul 2024
Primary completion
Feb 28, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention group: MILC application
    Eligible Hispanic participants in their third trimester will be recruited for the study. The intervention group will receive standard WIC services plus the MILC application.
  • Experimental: Control Group: Usual Care
    Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.

Primary Outcome Measure

Exclusive breastfeeding [ Time Frame: 1 month, 3 months and 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCONN HealthFarmingtonConnecticut06030-8084
Andrea D Shields, MD
[email protected]
860-679-4363
RTI InternationalResearch Triangle ParkNorth Carolina27709-2194
Yukiko Washio, PhD
[email protected]
919-541-5865
Temple UniversityPhiladelphiaPennsylvania19134-

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By research site
UCONN Health· Farmington, CTRTI International· Research Triangle Park, NCTemple University· Philadelphia, PA

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