Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Using Amamantapp

National University of San Marcos, Peru

Status: Completed

Conditions: Breast Feeding; Health Knowledge Attitudes and Practice

Treatments: Other: Education via printed leaflets; Device: Education on human milk donation via a mobile app Amamantapp

Study type: Interventional

Funder types: Other

Identifiers

NCT07477041

A21010491

Details and patient eligibility

About

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.

Full description

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).

The process of designing the intervention with the Amamantapp app was based on Human Centered Design (HCD) through the application of the Design Thinking technique. This technique consisted of 6 stages:

Stage 1: Recognition. Aimed at empathizing. Researchers defined the user profile and sociodemographic characteristics of breastfeeding mothers through in-depth interviews.

Stage 2: Identification of Needs. An empathy map was drawn up with the responses obtained to identify the needs of the users and the prioritization of the issues to be addressed regarding breastfeeding and milk donation.

Stage 3: Ideation of Solutions. A team of 6 researchers devised different innovative solutions (eg, digital educational booklet, mobile app, telephone counselling, SMS, and MMS), which were then evaluated using the impact and innovation matrix; a vote was taken considering the criteria of impact, innovation, added value, and scalability. Finally, the mobile app was the top-rated vote.

Stage 4: Prototyping. The intervention is prototyped as a mobile app, based on the HCD model. This model comprises sequential phases that range from defining the user requirement, designing the proposal, and through the implementation, verification, and maintenance of the intervention with the mobile app. The prototype was developed following the sequence previously described, which involved outlining the didactic content, the bibliographic search for educational content, the search for graphic resources, and the design of the screens, sections, and navigation routes.

The design process followed an iterative User Centered Design approach, incorporating feedback from experts in nutrition, health technology, human-computer interaction, and software development. The app employed a wireframe-based development approach, allowing early feedback on design decisions before implementation. The frontend was built with Flutter's Dart programming language, a cross-platform mobile development framework, to ensure broad accessibility on Android and iOS devices. The backend relies on a cloud-based infrastructure for data processing and secure storage. The app features personalized content delivery, ensuring that users receive relevant donation guidelines based on their location and eligibility. In addition, it includes built-in accessibility features, such as adjustable text sizes, to accommodate the diverse needs of users. The technical architecture prioritizes scalability, allowing for potential expansion across Peru and multiple countries in Latin America.

Stage 5: Usability Evaluation. The content was validated thorough an iterative process to improve the technological innovation tool until its final version. This iterative process evaluated the usability of the mobile app through a mixed study with a quantitative and qualitative phase to determine the experience of breastfeeding mothers hospitalized in the postpartum ward of a mother and child hospital in Lima. A validated 5-point Likert scale and in-depth interviews were used.

Stage 6: Effect Evaluation. With the final version of the technological innovation tool, the randomized controlled trial will be implemented for a period of 60 days. The research team will continuously conduct field evaluations of the tool's performance (verification) and ensure the maintenance of the intervention through push notifications, reminders, text messages (SMS), or other complementary resources. At this stage, a baseline and final measurement of indicators will also be assessed for both the intervention and control groups using a KAP questionnaire developed by the researchers. As part of this last stage, the qualitative component of the evaluation of the effect of the mobile intervention will be implemented. Purposive sampling will be used to recruit participants. Any breastfeeding mother from the intervention group who has completed the mobile intervention will be eligible to take part.

Enrollment: 112 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Intervention group: Mobile app-based education on Human Milk Donation

Experimental group

Description:

The intervention group will receive education on human milk donation via a mobile app. The intervention time will be 60 days.

Treatment:

Device: Education on human milk donation via a mobile app Amamantapp

Control group: Standard education on Human Milk Donation

Sham Comparator group

Description:

The control group will receive information on human milk donation through printed leaflets.

Treatment:

Other: Education via printed leaflets