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

Multi-modal Intervention for Lactation Care (MILC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breastfeeding, Exclusive
• Intervention / Treatment: Behavioral: MILC application; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tony Ma, MS; Phone Number: (703) 919-3234; Email: tonyma@bententech.com
• Study Contact Backup: Name: Katie Chang, MS; Phone Number: (703) 662-5858 x143; Email: hkchang@bententech.com

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030-8084
      • UCONN Health
      • Contact: Andrea D Shields, MD; Phone Number: 860-679-4363; Email: ashields@uchc.edu
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709-2194
      • RTI International
      • Contact: Yukiko Washio, PhD; Phone Number: 919-541-5865; Email: ywashio@rti.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: Control Group: Usual Care; Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding	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.	1 month, 3 months and 6 months
Any breastfeeding rate(EBF)	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.	1 month, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant weight (Medical outcomes)	Infant's weight using medical report collected at 1 month, 3 month and 6 months	Baseline, 1 month, 3 months and 6 months
Emergency department visit (Medical outcomes)	Number of emergency department visited for infant will be collected at 1 month, 3 month and 6 months	Baseline, 1 month, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BF history & attitudes questionnaire	New survey based on constructs that potentially moderate BF	Baseline, 1 month, 3 months and 6 months
Acceptance and Adoption	Technology Acceptance Model (TAM) will be used to assess acceptance of MILC app	Month 6 postpartum
Latching	It will be assessed using LATCH breastfeeding assessment scale. LATCH stands for latch, audible swallowing, type of nipple, comfort and hold. Each component is scored from 0-2. A LATCH score of 0-3 is regarded as poor, 4-7 as moderate, and 8-10 as good.	Baseline, 1 month, 3 months and 6 months
Self-Efficacy Scale	It will be assessed using the BF Self-Efficacy Scale Short Form (BSES-SF). The BSES-SF is a 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence. Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.	Baseline, 1 month, 3 months and 6 months
Iowa Infant Feeding Attitude	It will be collected using the Iowa infant feeding attitudes scale (IIFAS). The scale is composed of 17 items for assessing attitude towards BF. The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding	Baseline, 1 month, 3 months and 6 months
Acculturation	It will be assessed by using the Acculturation Rating Scale for Mexican Americans II. The scale contains 48 items to which participants respond on a 5-point Likert scale ranging from "Not at all" to "Extremely often or almost always," with higher scores indicating greater cultural orientation.	Baseline, 1 month, 3 months and 6 months
Postnatal depression	It will be assessed using Edinburgh Postnatal depression Scale (EPDS). The EPDS has a maximum score of 30; a score of 10 or more may indicate possible depression of varying severity.	Baseline, 1 month, 3 months and 6 months
Usability	System Usability Scale (SUS)survey will be used to assess usability of the MILC app. A SUS score above 68 would be considered above average and anything below 68 is below average.	Month 6 postpartum

Collaborators and Investigators

• Sponsor: Benten Technologies, Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Temple University; UConn Health; RTI International
• Investigators: Principal Investigator: Yukiko Washio, PhD, RTI International; Principal Investigator: Tony Ma, MS, Benten Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: breastfeeding; exclusive breastfeeding; breastfeeding support; breastfeeding education
• Other Study ID Numbers: MILC; R44MD017174 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No