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Clinical Trials/NCT06520696
NCT06520696Not yet recruitingNot Applicable

Multi-modal Intervention for Lactation Care (MILC)

Benten Technologies, Inc.6 sites in 1 country178 target enrollmentStarted: August 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
178
Locations
6
Primary Endpoint
Any breastfeeding rate(EBF)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Emergency department visit (Medical outcomes)(Baseline, 1 month, 3 months and 6 months)
  • Infant weight (Medical outcomes)(Baseline, 1 month, 3 months and 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Tony Ma

Project Director or Principal Investigator

Benten Technologies, Inc.

Study Sites (6)

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