NCT06520696

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

Multi-modal Intervention for Lactation Care (MILC)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Benten Technologies, Inc. · Industry
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breastfeeding, Exclusive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2024-07-25
• Last updated: 2024-07-26

Locations

3 sites across 1 country: United States