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临床试验/NCT05985876
NCT05985876Enrolling By Invitation2 期

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

Benten Technologies, Inc.6 个研究点 分布在 1 个国家目标入组 523 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
Enrolling By Invitation
入组人数
523
试验地点
6
主要终点
Change of exclusive breastfeeding (EBF) rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change of exclusive breastfeeding (EBF) rates

时间窗: Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up

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.

次要结局

  • Change of breastfeeding initiation rates(Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up)
  • Change of any breastfeeding (BF) rates(Baseline, week 4 postpartum follow-up and week 24 postpartum follow-up)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Tony Ma

Project Director or Principal Investigator

Benten Technologies, Inc.

研究点 (6)

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