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

NCT06520696 | Not Yet Recruiting

• 2 other identifiers: MILCR44MD017174
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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.

Conditions

Breastfeeding, Exclusive

Keywords

breastfeeding; breastfeeding education; breastfeeding support; exclusive breastfeeding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Infant weight (Medical outcomes)

  Baseline, 1 month, 3 months and 6 months

• Emergency department visit (Medical outcomes)

  Baseline, 1 month, 3 months and 6 months

Other Outcomes (8)

• Latching

  Baseline, 1 month, 3 months and 6 months

• BF history & attitudes questionnaire

  Baseline, 1 month, 3 months and 6 months

• Self-Efficacy Scale

  Baseline, 1 month, 3 months and 6 months

Study Arms (2)

Intervention group: MILC application

EXPERIMENTAL

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

Control Group: Usual Care

EXPERIMENTAL

Participants in the control group will receive care as usual with standard breastfeeding services from the WIC program.

Behavioral: Usual care

Interventions

MILC application BEHAVIORAL

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.

Intervention group: MILC application

Usual care BEHAVIORAL

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.

Control Group: Usual Care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: The proposed study seeks to enroll pregnant or post-partum Hispanic women. Given the focus of the proposed research, the study will only recruit female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Participants who are under the age of 18 or over 44
• Women experiencing a fetal demise or infant death
• 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

Sponsors & Collaborators

• Benten Technologies, Inc.: lead
• RTI International: collaborator
• Temple University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• UConn Health: collaborator

Study Sites (3)

UCONN Health

Farmington, Connecticut, 06030-8084, United States

Location

RTI International

Research Triangle Park, North Carolina, 27709-2194, United States

Location

Temple University

Philadelphia, Pennsylvania, 19134, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Tony Ma, MS

  Benten Technologies

  PRINCIPAL INVESTIGATOR

• Yukiko Washio, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Ma, MS

CONTACT

(703) 919-3234; tonyma@bententech.com

Katie Chang, MS

CONTACT

(703) 662-5858 x143; hkchang@bententech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director or Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)