KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding

Breastfeeding Clinical Trial

— KULEA-NET  

Official title:

Knowledge and Usage of Lactation Using Education and Advice From Support Network (KULEA-NET)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05985876
• Other study ID #: KULEA-NET
• Secondary ID: 1R44MD016829-01A
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: August 2023
• Source: Benten Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 523
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Exclusive Breastfeeding

Intervention

Behavioral:
• KULEA-NET application
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 Group: Usual Care
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).

Locations

Country	Name	City	State
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	Mamatoto Village	Washington	District of Columbia
United States	The George Washington University	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Benten Technologies, Inc.	George Washington University, Medstar Health Research Institute, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of breastfeeding attitudes	Iowa Infant Feeding Attitude Scale (IIFAS)	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Other	Change of intention to breastfeed	Infant Feeding Intentions (IFI) Scale	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Other	Change of breastfeeding self-efficacy	BF Self-Efficacy Scale Short Form (BSES-SF)	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Other	Change of perceived social support and social self-efficacy	Interpersonal Support Evaluation List (ISEL)	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Other	Usability	System Usability Scale (SUS)survey will be used to assess usability of the KULEA-NET app	Week 24 postpartum
Other	Engagement	Brand Equity Scale to measure engagement with the app	Week 24 postpartum
Other	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.	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Primary	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.	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Secondary	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.	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up
Secondary	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.	Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up