About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participants who are under the age of 18 or over 44
Women experiencing a fetal demise or infant death
Human immunodeficiency virus (HIV)
Taking antiretroviral medication or chemotherapy agents
Trial design
Parallel
Treatments tested in this trial
MILC application
BehavioralEligible 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 care
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Infant weight (Medical outcomes)
Infant's weight using medical report collected at 1 month, 3 month 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
Other outcomes
Latching
It will be assessed using LATCH breastfeeding assessment scale. LATCH stands for latch, audible swallowing, type of nipple, comfort and hold. Each component is scored from 0-2. A LATCH score of 0-3 is regarded as poor, 4-7 as moderate, and 8-10 as good.
BF history & attitudes questionnaire
New survey based on constructs that potentially moderate BF
Self-Efficacy Scale
It will be assessed using the BF Self-Efficacy Scale Short Form (BSES-SF). The BSES-SF is a 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence. Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.
Iowa Infant Feeding Attitude
It will be collected using the Iowa infant feeding attitudes scale (IIFAS). The scale is composed of 17 items for assessing attitude towards BF. The total IIFAS score can range from 17 to 85 with higher scores reflecting positive attitude towards breastfeeding
Sponsors and contacts
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Benten Technologies, Inc.
Lead sponsor
RTI International
Collaborator
Temple University
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
UConn Health
Collaborator
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