KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding
- Conditions
- BreastfeedingExclusive Breastfeeding
- Interventions
- Behavioral: KULEA-NET application
- Registration Number
- NCT05985876
- Lead Sponsor
- Benten Technologies, Inc.
- Brief Summary
KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and intentions related to exclusive breastfeeding (EBF). These factors have been demonstrated to have a positive influence on breastfeeding (BF) initiation and duration among African American/Black (AA/B) mothers. In the long term, KULEA-NET has great potential to achieve increased BF initiation and EBF rates among AA/B mothers and as a result, improved maternal and infant health outcomes.
- Detailed Description
Failure to initiate breastfeeding (BF) and exclusively breastfeed (EBF) for the recommended 6-month duration, can result in long-term morbidity among both mothers and their infants. African Americans/Blacks (AA/B) have the lowest BF initiation and EBF rates among all racial ethnicities in the US. AA/B infants have disproportionately high rates of mortality, and children have a high incidence of asthma and sudden infant death syndrome (SIDS) while AA/B mothers are at high risk for chronic illnesses like obesity, diabetes, and cardiovascular diseases. These health disparities cost the US more than $9.1 billion in medical treatment annually but can be reduced by increasing EBF rates. However, AA/B women experience barriers on multiple levels to initiating, continuing BF, and maintaining EBF (either by discontinuing BF or introducing supplements BF with other foods). With high rates of smartphone ownership and consumption of digital content in AA/B women, the proposed mHealth intervention has great potential to increase BF initiation and maintain EBF among AA/B women and has demonstrated feasibility (user satisfaction and use) in our prior completed feasibility study. The proposed SBIR Direct Phase II application, Knowledge and Usage of Lactation using Education and Advice from Support Network (KULEA-NET) addresses an unmet need for an evidence-based mobile app, providing comprehensive BF support and addresses the interrelated and complex BF barriers AA/B mothers experience across the socio-ecological layers.
KULEA-NET will provide comprehensive BF support to nurture and support AA/B women in BF initiation and EBF, and include the following innovative features: a) Social marketing and health branding to promote EBF as a socially desirable behavior; b) Micro-learning educational content to improve the acquisition of knowledge and skills related to EBF; c) Support network communication tools leveraging asynchronous communication that allow mothers to communicate with her BF supporters, peers, and lactation professional supports; d) Context-aware delivery framework that will capitalize on user information such as date of delivery, feeding, and diaper log data, and location variables to provide timely feedback, content, and guidance; and e) a Virtual community support network bringing together AA/B mothers and their spouse/family members, and fostering a community of mutual support.
The hypothesize of KULEA-NET is to improve knowledge, BF self-efficacy, and intentions to BF, and ultimately achieve increased BF initiation, BF duration, and EBF rates at 6 months among AA/B mothers and, as a result, improved maternal and infant health outcomes.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 523
- African American/Black Ethnicity
- Speak and understand English,
- Between the ages of 18-44 years,
- Intention to continue BF after discharge from the hospital
- Willingly provide written informed consent
- Own a smartphone (either iOS or Android)
- Have access to the internet through their smartphone
- An infant born with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions that require admission to a NICU or interfere with BF
- 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
- Active hepatitis B or C
- Any prescription drug use incompatible with lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KULEA-NET application KULEA-NET application Participants using the KULEA-NET application in addition to the usual care
- Primary Outcome Measures
Name Time Method Change of exclusive breastfeeding (EBF) rates Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up We will assess if participants are breastfeeding exclusively through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on EBF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.
- Secondary Outcome Measures
Name Time Method Change of breastfeeding initiation rates Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up We will assess if participants are initiated breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF initiation at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm.
Change of any breastfeeding (BF) rates Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up We will assess if participants are breastfeeding through self-reported information and corroborate with data entered in the feeding and diaper logs. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #1. We will record information on BF at 4 weeks, and 24 weeks follow-up among women in the intervention arm #2. We will record information on EBF at baseline, 4 weeks, and 24 weeks follow-up among women in the intervention arm #3.
Trial Locations
- Locations (3)
Mamatoto Village
🇺🇸Washington, District of Columbia, United States
Medstar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
The George Washington University
🇺🇸Washington, District of Columbia, United States