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

NCT ID: NCT06520696

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-06-30

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.

Conditions

Breastfeeding, Exclusive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MILC application

Intervention Type: 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.

Control Group: Usual Care

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

Group Type: EXPERIMENTAL

Usual care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

RTI International

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: collaborator

Benten Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Tony Ma

Project Director or Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony Ma, MS

Role: PRINCIPAL_INVESTIGATOR

Benten Technologies

Yukiko Washio, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

UCONN Health

Farmington, Connecticut, United States

RTI International

Research Triangle Park, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Tony Ma, MS

Role: CONTACT

tonyma@bententech.com

(703) 919-3234

Katie Chang, MS

Role: CONTACT

hkchang@bententech.com

(703) 662-5858 x143

Facility Contacts

Andrea D Shields, MD

Role: primary

ashields@uchc.edu

860-679-4363

Yukiko Washio, PhD

Role: primary

ywashio@rti.org

919-541-5865

Other Identifiers

R44MD017174

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MILC

Identifier Type: -

Identifier Source: org_study_id