MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
- Conditions
- Breastfeeding, Exclusive
- Interventions
- Behavioral: MILC applicationBehavioral: Usual care
- Registration Number
- NCT06520696
- Lead Sponsor
- Benten Technologies, Inc.
- 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 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.
- 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, diarrhea, asthma, and sudden infant death syndrome (SIDS).
Despite high breastfeeding (BF) initiation of approximately 80% among the Hispanic population in the United States (US), less than 25% of infants were exclusively breastfed (EBF) through 6 months, further perpetuating ethnic disparities in chronic diseases such as diabetes, obesity, and hypertension. Hispanic women are more likely to supplement feeding with formula, than non-Hispanic or African American (AA) mothers. Research has reported that barriers such as insufficient BF education, lack of BF technical support (i.e. latching issues, sore nipples), returning to work, easy access to free or discounted formula milk from Women Infants and Children (WIC), lack of social support, perceived inconvenience, cultural belief that both formula and breastmilk (los-dos) is best for the babies, perception that the infant is not satiated, and embarrassment associated with breastfeeding result in premature weaning off BF among low-income Hispanic mothers. Therefore, increasing the duration of EBF and continuous BF among low-income Hispanic women would require an innovative and comprehensive approach that addresses the diverse range of barriers listed above.
The investigators hypothesize that MILC will show significantly higher percentages of BF mothers in the intervention group at each time (1 month, 3 months, and 6 months) point compared with the control group. In the short term, MILC will be shown to be usable and acceptable by Hispanic BF mothers to receive BF support, education, and guidance from primary care providers (PCP) and certified lactation consultants/international board certified lactation consultants (CLC/IBCLC). In the long term, the impact of MILC will increase the rates of EBF for up to 6 months along with increasing rates of any BF up to 12 months.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group: MILC application 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. Control Group: Usual Care Usual care Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.
- Primary Outcome Measures
Name Time Method Any breastfeeding rate(EBF) 1 month, 3 months and 6 months Investigators will assess if participants are continuous breastfeeding through monthly breastfeeding videos uploaded in the system. Investigators will report information on any breastfeeding at 1 month, 3 months and 6 months.
Exclusive breastfeeding 1 month, 3 months and 6 months Investigators will assess if participants are breastfeeding exclusively (EBF)through monthly self-reported information. Investigators will record information on EBF at 1 month, 3 months and 6 months among women in the intervention arm.
- Secondary Outcome Measures
Name Time Method Emergency department visit (Medical outcomes) Baseline, 1 month, 3 months and 6 months Number of emergency department visited for infant will be collected at 1 month, 3 month and 6 months
Infant weight (Medical outcomes) Baseline, 1 month, 3 months and 6 months Infant's weight using medical report collected at 1 month, 3 month and 6 months
Trial Locations
- Locations (3)
UCONN Health
🇺🇸Farmington, Connecticut, United States
RTI International
🇺🇸Research Triangle Park, North Carolina, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States