Breastfeeding, ExclusiveMILCNCT06520696
MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
A study testing MILC application in people with Breastfeeding, Exclusive, run by Benten Technologies, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- MILC application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 29Show fewer
- 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):
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCONN Health
Farmington, Connecticut, 06030-8084
Temple University
Philadelphia, Pennsylvania, 19134
RTI International
Research Triangle Park, North Carolina, 27709-2194
About this study
Official title: 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.
Read the 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
- Being tested
- MILC application, Usual care
- Keywords
- breastfeeding, breastfeeding education, breastfeeding support, exclusive breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILC applicationBehavioural
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.
Usual careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month, 3 months and 6 months
Secondary outcomes (2)
Infant weight (Medical outcomes)
Infant's weight using medical report collected at 1 month, 3 month and 6 months
Measured: 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
Measured: Baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Jun 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: Lapse in SBIR reauthorization and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benten Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI International, Temple University, National Institute on Minority Health and Health Disparities (NIMHD), UConn Health
- Responsible party
- Principal investigator, Tony Ma, Benten Technologies, Inc.
- Investigators
- Tony Ma, MS, Principal investigator, Benten TechnologiesYukiko Washio, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520696
- Sponsor's protocol ID
- MILC
- Other IDs
- R44MD017174
- Acronym
- MILC
- Status last verified
- Jan 2026
- First submitted
- 20 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Intervention for Lactation Care (MILC)
- ClinicalTrials.gov ID
- NCT06520696
- Acronym / sponsor ID
- MILC / MILC
- Conditions
- Breastfeeding, Exclusive
- Keywords
- breastfeeding, breastfeeding education, breastfeeding support, exclusive breastfeeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lapse in SBIR reauthorization and lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Benten Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- RTI International, Temple University, National Institute on Minority Health and Health Disparities (NIMHD), UConn Health
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: MILC application | Experimental | Behavioral: MILC applicationEligible Hispanic participants in their third trimester will be recruited for the study. The intervention group will receive standard WIC services plus the MILC application. |
| Control Group: Usual Care | Experimental | Behavioral: Usual careParticipants in the control group will receive care as usual with standard breastfeeding services from the WIC program. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILC applicationEligible 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. | Behavioural | Intervention group: MILC application |
| Usual careParticipants 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. | Behavioural | Control Group: Usual Care |
Primary outcome
Exclusive breastfeeding
Time frame: 1 month, 3 months and 6 months
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.
Any breastfeeding rate(EBF)
Time frame: 1 month, 3 months and 6 months
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.
2 secondary outcomes
Infant weight (Medical outcomes)
Time frame: Baseline, 1 month, 3 months and 6 months
Emergency department visit (Medical outcomes)
Time frame: Baseline, 1 month, 3 months and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Ma, MS principal investigator
Benten Technologies
Yukiko Washio, PhD principal investigator
RTI International
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILC application in people with Breastfeeding, Exclusive, run by Benten Technologies, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: 1 month, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.