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

NCT05985876 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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).

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER
  • Medstar Health Research Institute

    collaborator OTHER
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Benten Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Tony Ma, MS · Benten Technologies

  • Doug Evans, PhD · George Washington University

  • Loral Patchen, PhD · Medstar Research Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-04-30
Completion
2024-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985876 on ClinicalTrials.gov