SBIR-STTR Award

Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform to increase
Award last edited on: 4/26/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NIMHD
Total Award Amount
$1,138,522
Award Phase
2
Solicitation Topic Code
307
Principal Investigator
Tony Xuyen Ma

Company Information

Benten Technologies Inc

9408 Grant Avenue Suite 206
Manassas, VA 20110
   (703) 662-5858
   N/A
   www.bententech.com
Location: Single
Congr. District: 10
County: Manassas

Phase I

Contract Number: 1R44MD017174-01
Start Date: 9/18/2021    Completed: 5/31/2022
Phase I year
2021
Phase I Amount
$313,508
The 2017 Centers for Disease Control and Prevention's (CDC) Breastfeeding Report Card reported thatdespite a high breastfeeding (BF) initiation of approximately 80% among the Hispanic population in the UnitedStates (US), less than 25% of infants were exclusively breastfed (EBF) through 6 months, further perpetuatingethnic disparities in chronic diseases such as diabetes, obesity, and hypertension. Hispanic women are morelikely to supplement feeding with formula, than non-Hispanic or African American (AA) mothers. Research hasreported that barriers such as insufficient BF education, lack of BF technical support (i.e. latching issues, sorenipples), 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 withbreastfeeding result in premature weaning off BF among low-income Hispanic mothers. Therefore, increasingthe duration of EBF and continuous BF among low-income Hispanic women would require an innovative andcomprehensive approach that addresses the diverse range of barriers listed above. The proposed Fast-trackproposal titled Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform that consists ofthe following innovative components: 1) Chat bot system to provide virtual peer counselor support; 2) Use ofescalating magnitude of incentives contingent on remotely observed breastfeeding; 3) Asynchronous andsynchronous communication tools to facilitate lactation and social support; and 4) Virtual peer mother tomother support network. We propose the following aims for the Phase I:1) Conduct formative research with a) low-income Hispanic mothers, b) Certified and international board-certified lactation consultants (CLCs/IBCLCs) and c) in-depth Interviews (IDI)s with WIC staffs/primary careproviders (PCPs).2) Conduct pilot testing of MILC prototype with 20 low-income Hispanic BF mothers who delivered their babiesat TUH and 5 CLC/IBCLCs working at TUH to demonstrate feasibility (usability and acceptance).We propose the following aims for the Phase II:1) Modify Phase I MILC prototype for commercialization and;2) Conduct a randomized control trial (RCT) with 178 participants from TUH and Christiana Care HealthSystem (CCHS) and 20 CLCs/IBCLCs on MILC to assess MILC's efficacy to significantly improve EBF rates at6 months including increasing rates of any BF at month 1, month 3 and month 6.In the long term, the impact of MILC will increase the rates of EBF up to 6 months along with increasing ratesof any BF up to 12 months.

Public Health Relevance Statement:
PROJECT NARRATIVE 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 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.

Project Terms:
Academy ; Asthma ; Bronchial Asthma ; Behavior ; Belief ; Breast Feeding ; Breast fed ; Breastfed ; Breastfeeding ; Felis catus ; Cats ; Cats Mammals ; Domestic Cats ; Feline Species ; Felis domestica ; Felis domesticus ; Felis sylvestris catus ; Centers for Disease Control and Prevention (U.S.) ; CDC ; Centers for Disease Control ; Centers for Disease Control and Prevention ; United States Centers for Disease Control ; United States Centers for Disease Control and Prevention ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Chronic Disease ; Chronic Illness ; chronic disorder ; Communication ; Control Groups ; Professional counselor ; Counselor ; Diabetes Mellitus ; diabetes ; Diarrhea ; Education ; Educational aspects ; Face ; faces ; facial ; Gastroenteritis ; Healthcare Systems ; Health Care Systems ; Hospitals ; University Hospitals ; Hypertension ; Vascular Hypertensive Disease ; Vascular Hypertensive Disorder ; high blood pressure ; hyperpiesia ; hyperpiesis ; hypertensive disease ; Incentives ; Infant ; Insurance ; Interview ; Lactation ; lactating ; lactational ; Medicaid ; Methodology ; Human Milk ; Breast Milk ; Breastmilk ; Human Mother's Milk ; Mammary Gland Milk ; Mother's Milk ; maternal milk ; Minority Groups ; Minority People ; Minority Population ; Mothers ; Nipples ; Obesity ; adiposity ; corpulence ; Pediatrics ; Perception ; Periodicity ; Cyclicity ; Rhythmicity ; Research ; Respiratory Tract Infections ; Respiratory Infections ; Risk ; Savings ; Social support ; social support network ; Sudden infant death syndrome ; Cot Death ; Crib Death ; SIDS ; Sudden Infant Death ; Sudden Unexpected Infant Death ; Complementary Feeding ; Supplementary Feedings ; Testing ; Time ; United States ; Weaning ; Woman ; Work ; Privacy ; African American ; Afro American ; Afroamerican ; Black Populations ; black American ; Businesses ; Health Benefit ; Hispanics ; Hispanic Populations ; Latino Population ; Spanish Origin ; hispanic community ; Caring ; Infant formula ; Baby Formula ; milk formula ; base ; improved ; Clinical ; premature ; prematurity ; Phase ; Exclusive Breastfeeding ; Exclusive Breast Feeding ; exclusively breast fed ; exclusively breast feeding ; exclusively breastfed ; exclusively breastfeeding ; Collaborations ; Life ; programs ; Hour ; System ; interest ; American ; Structure ; Participant ; peer ; Modality ; Reporting ; Intervention Strategies ; interventional strategy ; Intervention ; Drops ; telehealth ; Low income ; Address ; International ; randomisation ; randomization ; randomly assigned ; Randomized ; Communication Tools ; Not Hispanic or Latino ; Non-Hispanic ; Nonhispanic ; Scheme ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Principal Investigator ; Development ; developmental ; feeding ; virtual ; design ; designing ; Population ; innovation ; innovate ; innovative ; racial and ethnic ; ethnoracial ; encryption ; user centered design ; usability ; prototype ; commercialization ; control trial ; group intervention ; Secure ; multi-component intervention ; multi-faceted intervention ; multi-modal intervention ; multicomponent intervention ; multifaceted intervention ; multimodal intervention ; mHealth ; m-Health ; mobile health ; peer support ; support network ; individual patient ; ethnic disparity ; ethnicity disparity ; Lactation consultant ; lactation consultation ; Mobile Health Application ; Mobile Health App ; m-Health app ; m-Health application ; mHealth app ; mHealth application ; care providers ; primary care provider ; chatbot ; chat bot ; Precede-Proceed Model ;

Phase II

Contract Number: 4R44MD017174-02
Start Date: 9/18/2021    Completed: 8/31/2024
Phase II year
2022
Phase II Amount
$825,014
The 2017 Centers for Disease Control and Prevention's (CDC) Breastfeeding Report Card reported thatdespite a high breastfeeding (BF) initiation of approximately 80% among the Hispanic population in the UnitedStates (US), less than 25% of infants were exclusively breastfed (EBF) through 6 months, further perpetuatingethnic disparities in chronic diseases such as diabetes, obesity, and hypertension. Hispanic women are morelikely to supplement feeding with formula, than non-Hispanic or African American (AA) mothers. Research hasreported that barriers such as insufficient BF education, lack of BF technical support (i.e. latching issues, sorenipples), 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 withbreastfeeding result in premature weaning off BF among low-income Hispanic mothers. Therefore, increasingthe duration of EBF and continuous BF among low-income Hispanic women would require an innovative andcomprehensive approach that addresses the diverse range of barriers listed above. The proposed Fast-trackproposal titled Multi-modal Intervention for Lactation Care (MILC) will be a mHealth platform that consists ofthe following innovative components: 1) Chat bot system to provide virtual peer counselor support; 2) Use ofescalating magnitude of incentives contingent on remotely observed breastfeeding; 3) Asynchronous andsynchronous communication tools to facilitate lactation and social support; and 4) Virtual peer mother tomother support network. We propose the following aims for the Phase I:1) Conduct formative research with a) low-income Hispanic mothers, b) Certified and international board-certified lactation consultants (CLCs/IBCLCs) and c) in-depth Interviews (IDI)s with WIC staffs/primary careproviders (PCPs).2) Conduct pilot testing of MILC prototype with 20 low-income Hispanic BF mothers who delivered their babiesat TUH and 5 CLC/IBCLCs working at TUH to demonstrate feasibility (usability and acceptance).We propose the following aims for the Phase II:1) Modify Phase I MILC prototype for commercialization and;2) Conduct a randomized control trial (RCT) with 178 participants from TUH and Christiana Care HealthSystem (CCHS) and 20 CLCs/IBCLCs on MILC to assess MILC's efficacy to significantly improve EBF rates at6 months including increasing rates of any BF at month 1, month 3 and month 6.In the long term, the impact of MILC will increase the rates of EBF up to 6 months along with increasing ratesof any BF up to 12 months.

Public Health Relevance Statement:
PROJECT NARRATIVE 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 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.

Project Terms:
<0-11 years old>
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