Status:
NOT_YET_RECRUITING
MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
Lead Sponsor:
Benten Technologies, Inc.
Collaborating Sponsors:
RTI International
Temple University
Conditions:
Breastfeeding, Exclusive
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief 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 breastfee...
Detailed Description
Breastfeeding (BF) is positively associated with health benefits for infants. It reduces an infant's risks for various conditions such as respiratory tract infections, non-specific gastroenteritis, di...
Eligibility Criteria
Inclusion
- Inclusion Criteria for focus groups:
- Mothers who successfully exclusively breastfed for up to 6 months, at least one child OR mothers who attempted EBF but were unsuccessful at breastfeeding, in the past 3 years
- Self-identify as Hispanic
- Be WIC-eligible
- Voluntarily consent
- Speak English
- Inclusion Criteria for Randomized Control Trial (RCT):
- In their late third trimester (approximately 4 weeks from delivery)
- Can initiate BF immediately
- Self-identify as Hispanic
- Be WIC-eligible
- Voluntarily consent
- Not have psychiatric hospitalization within the last 3 months
- Not have current or suicidal thoughts or past attempts
- Own a smartphone device
- Speak English
- Exclusion Criteria for focus groups and Randomized Control Trial (RCT):
- Participants who are under the age of 18 or over 44
- Women experiencing a fetal demise or infant death
- Women who report the following conditions also will be excluded:
- Human immunodeficiency virus (HIV)
- Taking antiretroviral medication or chemotherapy agents
- Untreated, active tuberculosis
- T-Cell lymphotropic virus type I or type II
- Illicit drug use
- Receiving radiation therapy
- Exposed to anthrax
- Undergone breast surgery
- Known exposure to environmental toxins
- Active hepatitis B and C
- Prescription drug use incompatible with lactation
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06520696
Start Date
August 1 2024
End Date
June 1 2025
Last Update
July 26 2024
Active Locations (3)
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1
UCONN Health
Farmington, Connecticut, United States, 06030-8084
2
RTI International
Research Triangle Park, North Carolina, United States, 27709-2194
3
Temple University
Philadelphia, Pennsylvania, United States, 19134