Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Utilizing an Innovative Technological Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Average Change in Knowledge Scores Regarding Human Milk Donation on a KAP Questionnaire in Breastfeeding Mothers by Study Groups at 60 Days
研究概览
简要总结
In Peru, 7 out of 10 preterm babies die due to health complications. These newborns often cannot be breastfed by their own mothers and urgently need donated breast milk (BM) to survive. Human Milk Banks help to reduce mortality among preterm babies, but there are currently not enough donors to meet the high demand. Many mothers do not donate because they lack clear information or have concerns based on perceptions, beliefs, and attitudes that influence their predisposition to donate. The researchers had developed an innovative technological tool (ITT) called Amamantapp, a mobile application, to promote BM donation using the Design Thinking methodology to identify participants' needs, prioritize topics to be managed, and define the most appropriate ITT.
The goal of this clinical trial is to evaluate the effect of Amamantapp on the promotion of breast milk donation in breastfeeding mothers within 40 days of giving birth who are treated at the the National Maternal and Perinatal Hospital in Lima, Peru. The main questions it aims to answer are:
- Does the intervention using a technological tool raise the level of knowledge about breast milk donation among breastfeeding mothers?
- Does the intervention boost the attitude toward breast milk donation in breastfeeding mothers?
- Does the intervention raise the proportion of breastfeeding mothers who start breast milk donation practices? Participants will be randomly assigned to either an intervention group, which will use the technological tool for 60 days, or a control group. Researchers will measure changes in knowledge, attitudes, and practices (KAP) using a KAP questionnaire before and after the intervention period.
详细描述
This study is designed as a randomized controlled trial, to determine the effect of an innovative technological tool (ITT), the Amamantapp mobile application, on knowledge, attitudes, and practices towards human milk donation among breastfeeding women in Lima, Peru. This will provide a robust and reliable scientific contribution to help solve this problem and save the lives of more preterm infants.
The time of participation in the study will be approximately 3 months, divided into the following phases: enrollment (15 days), baseline assessment (7 days), exposure to the intervention (60 days), and final assessment (7 days).
To reduce bias, participants will be randomly assigned to the intervention and control groups in a 1:1 ratio according to their order of inclusion in the study. A master randomization list will be generated using the Spanish version of the free OxMaR software. The intervention group will receive education on human milk donation via a mobile app, and the control group will receive information on human milk donation through printed leaflets.
The app will be installed and explained to the mothers with hospital discharge orders on their mobile phones. The intervention will continue while the mothers are at home. The research team will hold an interactive session to introduce the mobile app to the participants. This will begin with an initial explanation of the app's features, followed by a period in which participants will be able to explore and use the application in real time. Furthermore, participants will receive weekly training on how to use the app to reinforce their knowledge of its operation.
AmamantApp app includes modules on breastfeeding basics, benefits of breastfeeding for mother and child, breast milk donation, benefits of donating breast milk, myths and beliefs about human milk donation, requirements to be a donor, and where to donate. The intervention period will last 60 days, during which knowledge, attitudes, and practices (KAP) will be assessed using a KAP questionnaire. This instrument will be administered face-to-face at baseline (pretest) and online via Google Forms after the intervention (posttest).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breastfeeding mothers within 40 days postpartum.
- •Breastfeeding mothers with living children.
- •Breastfeeding mothers with an active Internet connection.
- •Breastfeeding mothers who possess the technological equipment required to access the innovative technological tool (smartphone, tablet, or computer).
- •Breastfeeding mothers residing within the jurisdiction of the National Maternal and Perinatal Hospital.
排除标准
- •Breastfeeding mothers who are illiterate.
- •Breastfeeding mothers with a diagnosis of mental illness.
- •Breastfeeding mothers with significant difficulties in operating technological equipment.
- •Breastfeeding mothers who are current users of any milk bank.
- •Breastfeeding mothers who are or have been donors to the Human Milk Bank of the National Maternal and Perinatal Hospital.
研究组 & 干预措施
Intervention group: Mobile app-based education on Human Milk Donation
The intervention group will receive education on human milk donation via a mobile app. The intervention time will be 60 days.
干预措施: Education on human milk donation via a mobile app Amamantapp (Device)
Control group: Standard education on Human Milk Donation
The control group will receive information on human milk donation through printed leaflets.
干预措施: Education via printed leaflets (Other)
结局指标
主要结局
Average Change in Knowledge Scores Regarding Human Milk Donation on a KAP Questionnaire in Breastfeeding Mothers by Study Groups at 60 Days
时间窗: Baseline and post-intervention at 60 days
Knowledge will be assessed using a questionnaire on knowledge, attitudes, and practices (KAP) related to human milk donation, developed by researchers and validated by experts. It includes a section consisting of eight questions measuring knowledge about human milk donation, with a score ranging from 0 to 8. Knowledge scores are classified according to the total score as follows: Low (0-2 points), Medium (3-5 points), and High (6-8 points). The results will be expressed as the average change in knowledge scores from baseline to 60 days, comparing the intervention group and the control group.
Percentage of Breastfeeding Mothers with a Favorable Attitude toward Human Milk Donation on a KAP Questionnaire by Study Groups at baseline and 60 Days
时间窗: Baseline and post-intervention at 60 days
Attitudes will be assessed using a questionnaire on knowledge, attitudes, and practices (KAP) related to breast milk donation, developed by researchers and validated by experts. It includes a section consisting of ten questions to measure attitudes toward human milk donation using the attitude type indicator, with scores ranging from 0 to 10, with a range of 5 to 10 points for a favorable attitude and 0 to 4 points for an unfavorable attitude. The results will report the comparison of percentages between the intervention group and the control group from baseline to 60 days
Frequency of Human Milk Donations among Breastfeeding Mothers on a KAP Questionnaire by Study Groups at baseline and 60 Days
时间窗: Baseline and post-intervention at 60 days
Donation practice will be assessed using a questionnaire on knowledge, attitudes, and practices (KAP) related to human milk donation, developed by researchers and validated by experts. It includes a section consisting of three questions to determine the frequency of donations among participants in the intervention group compared to the control group from baseline to 60 days.
次要结局
未报告次要终点
研究者
Violeta Magdalena Rojas-Huayta
Principal Investigator
National University of San Marcos, Peru