MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
NCT Number: NCT06520696
Acronym: MILC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastfeeding, Exclusive
Interventions: BEHAVIORAL: MILC application|BEHAVIORAL: Usual care
Sponsor: Benten Technologies, Inc.
Collaborators: RTI International|Temple University|National Institute on Minority Health and Health Disparities (NIMHD)|UConn Health
Sex: FEMALE
Age: ADULT
Enrollment: 178
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-06
Locations: UCONN Health, Farmington, Connecticut, 06030-8084, United States|RTI International, Research Triangle Park, North Carolina, 27709-2194, United States|Temple University, Philadelphia, Pennsylvania, 19134, United States

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.

Primary Outcome Measures: 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: 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: 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|BF history & attitudes questionnaire, New survey based on constructs that potentially moderate BF, 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|Acceptance and Adoption, Technology Acceptance Model (TAM) will be used to assess acceptance of MILC app, Month 6 postpartum