Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520696
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
MILC A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-modal Intervention for Lactation Care MILC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILC
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 infants 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 ie 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 consultantsinternational board certified lactation consultants CLCIBCLC 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
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 ie 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 consultantsinternational board certified lactation consultants CLCIBCLC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None