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

NCT07477041 | Completed

• 1 other identifier: A21010491
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Knowledge Attitudes and Practice; Breast Feeding

Keywords

breast milk; breastfeeding women; mHealth; knowledge; attitudes; practice; breast milk donation

Outcome Measures

Primary Outcomes (3)

• Average Change in Knowledge Scores Regarding Human Milk Donation on a KAP Questionnaire in Breastfeeding Mothers by Study Groups 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.

  Baseline and post-intervention at 60 days

• Percentage of Breastfeeding Mothers with a Favorable Attitude toward Human Milk Donation on a KAP Questionnaire by Study Groups at baseline and 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

  Baseline and post-intervention at 60 days

• Frequency of Human Milk Donations among Breastfeeding Mothers on a KAP Questionnaire by Study Groups at baseline and 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.

  Baseline and post-intervention at 60 days

Study Arms (2)

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

EXPERIMENTAL

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

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

Control group: Standard education on Human Milk Donation

SHAM COMPARATOR

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

Other: Education via printed leaflets

Interventions

Education on human milk donation via a mobile app Amamantapp DEVICE

Participants will receive education on human milk donation over 60 days via AmamantApp app. This tool 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 app will be installed and explained to the mothers with hospital discharge orders on their mobile phones. 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. The intervention will continue while the mothers are at home. Furthermore, participants will receive weekly training on how to use the app to reinforce their knowledge of its operation. Knowledge, attitudes, and practices will be assessed before and after the intervention.

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

Education via printed leaflets OTHER

Participants will receive information on human milk donation through printed leaflets. A baseline and final measurement of knowledge, attitudes, and practices of control group participants will be conducted using a KAP questionnaire.

Control group: Standard education on Human Milk Donation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of San Marcos, Peru: lead

Study Sites (1)

National Maternal and Perinatal Hospital (NMPH)

Lima, Lima Province, Peru

Location

Related Publications (14)

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  PMID: 32469315 BACKGROUND

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• León-Mauricio Z, Villanueva-Medina C, Dávila-Aliaga C. Human milk bank: strategy for the reduction of neonatal morbidity and mortality at the Instituto Nacional Materno Perinatal. Rev Peru Investig Matern Perinat. 2016;5(2):31-36. Available from: https://doi.org/10.33421/inmp.201663

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Padro-Arocas A, Quifer-Rada P, Aguilar-Camprubi L, Mena-Tudela D. Description of an mHealth tool for breastfeeding support: LactApp. Analysis of how lactating mothers seek support at critical breastfeeding points and according to their infant's age. Res Nurs Health. 2021 Feb;44(1):173-186. doi: 10.1002/nur.22095. Epub 2020 Dec 15.

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  PMID: 27185505 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Behavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The development of the mobile intervention was based on the Human-Centered Design approach. 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 intervention period will last 60 days, during which knowledge, attitudes, and practices (KAP) will be assessed using a KAP questionnaire.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: Requests for IPD and supporting information should be directed to the principal investigator via email.

Locations

PE (1)