Clinical trial NCT05985876: KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding
Official title: Knowledge and Usage of Lactation Using Education and Advice From Support Network (KULEA-NET)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Breastfeeding
Exclusive Breastfeeding
Lead sponsor: Benten Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: George Washington University
name: Medstar Health Research Institute
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-14
Enrollment: 523
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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: text messages, a knowledge base, 3 different types of videos, and breastfeeding-friendly spaces and breastfeeding classes near them.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of exclusive breastfeeding (EBF) rates
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Secondary outcomes:
measure: Change of any breastfeeding (BF) rates
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
measure: Change of breastfeeding initiation rates
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Other outcomes:
measure: Change of breastfeeding attitudes
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
measure: Change of intention to breastfeed
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
measure: Change of breastfeeding self-efficacy
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
measure: Change of perceived social support and social self-efficacy
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
measure: Usability
timeFrame: Week 24 postpartum
measure: Engagement
timeFrame: Week 24 postpartum
measure: Change of knowledge and beliefs about breastfeeding
timeFrame: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Locations:
city: Washington
country: United States
facility: Mamatoto Village
state: District of Columbia
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
city: Hyattsville
country: United States
facility: Medstar Health Research Institute
state: Maryland
Study officials:
affiliation: Benten Technologies
name: Tony Ma, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Doug Evans, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Research Health Institute
name: Loral Patchen, PhD
role: PRINCIPAL_INVESTIGATOR
References: