A Phase 2 interventional study of KULEA-NET application and Control Group: Usual Care in Breastfeeding and Exclusive Breastfeeding, sponsored by Benten Technologies, Inc.. Enrolling by invitation at 3 sites in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Benten Technologies, Inc. · Phase 2, Interventional, and Supportive care
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.
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.
Benten Technologies, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants using the KULEA-NET application in addition to the usual care
Behavioral: KULEA-NET application
Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive the standard Babyscripts app only without the KULEA-NET tile.
Behavioral: Control Group: Usual Care
African American/Black (AA/B) women recruited at 3 distinct stages of pregnancy - i.e. 1) 29 to 34 weeks gestational age, 2) 35 to 40 weeks gestational age, and 3)immediately post-partum, will be assigned to the intervention group and start using the KULEA-NET platform. Women in the intervention arm #1 will use KULEA-NET for a total duration of approximately 9 months (3 months prenatal and 6 months post-partum; women in the intervention arm #2 will use KULEA-NET for a total duration of approximately 7 months (1 month prenatal and 6 months post-partum); and women in the intervention arm #3 will use KULEA-NET for a total duration of approximately 6 months (only post-partum). Each woman will have access to all components of the KULEA-NET platform: the text messages, knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.
Control participants will receive usual care i.e. standard obstetrical care at MWHC and Mamatoto Village and will receive standard Babyscripts app only without the KULEA-NET tile. Information from the ACOG about the maternal and infant health benefits of breastfeeding will also be provided (e.g., they will get pamphlets on the importance of breastfeeding as well as lactation consultation).
Change of exclusive breastfeeding (EBF) rates
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.
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of any breastfeeding (BF) rates
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.
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of breastfeeding initiation rates
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.
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of breastfeeding attitudes
Iowa Infant Feeding Attitude Scale (IIFAS)
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of intention to breastfeed
Infant Feeding Intentions (IFI) Scale
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of breastfeeding self-efficacy
BF Self-Efficacy Scale Short Form (BSES-SF)
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Change of perceived social support and social self-efficacy
Interpersonal Support Evaluation List (ISEL)
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Usability
System Usability Scale (SUS)survey will be used to assess usability of the KULEA-NET app
Time frame: Week 24 postpartum
Engagement
Brand Equity Scale to measure engagement with the app
Time frame: Week 24 postpartum
Change of knowledge and beliefs about breastfeeding
Custom survey, based in part on an instrument developed by Dr. Evans and colleagues to evaluate the KULEA-NET intervention (GWU IRB approval # 111047), will be used to collect self-reported knowledge and attitudes related to breastfeeding.
Time frame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
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Benten Technologies, Inc.