Clinical trial NCT06520696: MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
Official title: Multi-modal Intervention for Lactation Care (MILC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding, Exclusive
Keywords: breastfeeding
breastfeeding education
breastfeeding support
exclusive breastfeeding
Lead sponsor: Benten Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: RTI International
name: Temple University
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: UConn Health
First posted: 2024-07-25
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. Participants will be asked to participate in the periodic follow-up assessments at 1, 3, and 6 months along with demonstrating breastfeeding via the MILC app. Participants in the control group will receive 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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):

1. Participants who are under the age of 18 or over 44
2. Women experiencing a fetal demise or infant death
3. 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

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: 1 month, 3 months and 6 months
measure: Any breastfeeding rate(EBF)
timeFrame: 1 month, 3 months and 6 months
Secondary outcomes:
measure: Infant weight (Medical outcomes)
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Emergency department visit (Medical outcomes)
timeFrame: Baseline, 1 month, 3 months and 6 months
Other outcomes:
measure: Latching
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: BF history & attitudes questionnaire
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Self-Efficacy Scale
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Iowa Infant Feeding Attitude
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Acculturation
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Postnatal depression
timeFrame: Baseline, 1 month, 3 months and 6 months
measure: Usability
timeFrame: Month 6 postpartum
measure: Acceptance and Adoption
timeFrame: Month 6 postpartum
Locations:
city: Farmington
country: United States
facility: UCONN Health
state: Connecticut
city: Research Triangle Park
country: United States
facility: RTI International
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Benten Technologies
name: Tony Ma, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Yukiko Washio, PhD
role: PRINCIPAL_INVESTIGATOR
References: