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

NCT05985876 | Unknown Phase 2 DMC

• 2 other identifiers: KULEA-NET1R44MD016829-01A1
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 3

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.

Conditions

Breastfeeding; Exclusive Breastfeeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of any breastfeeding (BF) rates

  Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

• Change of breastfeeding initiation rates

  Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

Other Outcomes (7)

• Change of breastfeeding attitudes

  Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

• Change of intention to breastfeed

  Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

• Change of breastfeeding self-efficacy

  Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

Study Arms (2)

KULEA-NET application

EXPERIMENTAL

Participants using the KULEA-NET application in addition to the usual care

Behavioral: KULEA-NET application

Control Group: Usual Care

EXPERIMENTAL

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

Interventions

KULEA-NET application BEHAVIORAL

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.

KULEA-NET application

Control Group: Usual Care BEHAVIORAL

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).

Control Group: Usual Care

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: The proposed study seeks to enroll approximately pregnant or post-partum African American/Black (AA/B) women. Given the focus of the proposed research, we will only recruit women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benten Technologies, Inc.: lead
• George Washington University: collaborator
• Medstar Health Research Institute: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Mamatoto Village

Washington D.C., District of Columbia, 20019-3739, United States

Location

The George Washington University

Washington D.C., District of Columbia, 20052-0042, United States

Location

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Tony Ma, MS

  Benten Technologies

  PRINCIPAL INVESTIGATOR

• Doug Evans, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• Loral Patchen, PhD

  Medstar Research Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director or Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (3)