Health Knowledge Attitudes and PracticeNCT07477041
Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Using Amamantapp
A study testing Education on human milk donation via a mobile app Amamantapp and Education via printed leaflets in people with Health Knowledge Attitudes and Practice and Breast Feeding, run by National University of San Marcos, Peru at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Health Knowledge Attitudes and Practice, Breast Feeding
- What is being tested?
- Education on human milk donation via a mobile app Amamantapp and Education via printed leaflets
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 sitePeru
- Study dates
- 1 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Utilizing an Innovative Technological Tool
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.
Read the detailed 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.
- Being tested
- Education on human milk donation via a mobile app Amamantapp, Education via printed leaflets
- Keywords
- breast milk, breastfeeding women, mHealth, knowledge, attitudes, practice, breast milk donation
- Medical subject headings
- Breast Feeding, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on human milk donation via a mobile app AmamantappDevice
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.
Education via printed leafletsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education via printed leaflets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline and post-intervention at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge Attitudes and PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of San Marcos, Peru
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Violeta Magdalena Rojas-Huayta, National University of San Marcos, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477041
- Sponsor's protocol ID
- A21010491
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Arsand E, Demiris G. User-centered methods for designing patient-centric self-help tools. Inform Health Soc Care. 2008 Sep;33(3):158-69. doi: 10.1080/17538150802457562.
PubMed 18850399Gottgens I, Oertelt-Prigione S. The Application of Human-Centered Design Approaches in Health Research and Innovation: A Narrative Review of Current Practices. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28102. doi: 10.2196/28102.
PubMed 34874893Almohanna AA, Win KT, Meedya S. Effectiveness of Internet-Based Electronic Technology Interventions on Breastfeeding Outcomes: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17361. doi: 10.2196/17361.
PubMed 32469315Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873.
PubMed 29343463León-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
Darias AG. Evaluation of the "sponsor a first-time mother" intervention program in the promotion of breastfeeding [Internet]. [San Cristóbal de La Laguna]: University of La Laguna; 2017 [cited 2021 Feb 27]. Available from: https://dialnet.unirioja.es/servlet/tesis?codigo=236035
Sierra G. Milk donor women. Characterization of the population and study of hygiene measures for milk expression [PhD thesis]. Madrid: Complutense University of Madrid; 2017 [cited 2024 May 22]. Available from: https://eprints.ucm.es/id/eprint/41442/1/T38431.pdf
Heinig MJ. Host defense benefits of breastfeeding for the infant. Effect of breastfeeding duration and exclusivity. Pediatr Clin North Am. 2001 Feb;48(1):105-23, ix. doi: 10.1016/s0031-3955(05)70288-1.
PubMed 11236719Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
PubMed 22371471Wicinski M, Sawicka E, Gebalski J, Kubiak K, Malinowski B. Human Milk Oligosaccharides: Health Benefits, Potential Applications in Infant Formulas, and Pharmacology. Nutrients. 2020 Jan 20;12(1):266. doi: 10.3390/nu12010266.
PubMed 31968617Gómez García GZ, Kikukawa Poma KY. Beliefs, attitudes and practices regarding breast milk donation to the human milk bank in postpartum women at the Hospital Nacional Docente Madre Niño San Bartolomé, September to December 2019. Lima: Universidad Científica del Sur. 2020. Available from: https://repositorio.cientifica.edu.pe/handle/20.500.12805/924
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.
PubMed 33319403Wang CJ, Chaovalit P, Pongnumkul S. A Breastfeed-Promoting Mobile App Intervention: Usability and Usefulness Study. JMIR Mhealth Uhealth. 2018 Jan 26;6(1):e27. doi: 10.2196/mhealth.8337.
PubMed 29374000Joshi A, Amadi C, Meza J, Aguire T, Wilhelm S. Evaluation of a computer-based bilingual breastfeeding educational program on breastfeeding knowledge, self-efficacy and intent to breastfeed among rural Hispanic women. Int J Med Inform. 2016 Jul;91:10-9. doi: 10.1016/j.ijmedinf.2016.04.001. Epub 2016 Apr 2.
PubMed 27185505
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Breast Milk Donation in Breastfeeding Mothers Through a Mobile Health Intervention Utilizing an Innovative Technological Tool
- ClinicalTrials.gov ID
- NCT07477041
- Acronym / sponsor ID
- A21010491
- Keywords
- breast milk, breastfeeding women, mHealth, knowledge, attitudes, practice, breast milk donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National University of San Marcos, PeruUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Mobile app-based education on Human Milk Donation | Experimental | Device: Education on human milk donation via a mobile app AmamantappThe intervention group will receive education on human milk donation via a mobile app. The intervention time will be 60 days. |
| Control group: Standard education on Human Milk Donation | Sham comparator | Other: Education via printed leafletsThe control group will receive information on human milk donation through printed leaflets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on human milk donation via a mobile app AmamantappParticipants 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. | Device | Intervention group: Mobile app-based education on Human Milk Donation |
| Education via printed leafletsParticipants 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. | Other | Control group: Standard education on Human Milk Donation |
Primary outcome
Average Change in Knowledge Scores Regarding Human Milk Donation on a KAP Questionnaire in Breastfeeding Mothers by Study Groups at 60 Days
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 18850399Arsand E, Demiris G. User-centered methods for designing patient-centric self-help tools. Inform Health Soc Care. 2008 Sep;33(3):158-69. doi: 10.1080/17538150802457562.
- Background: PubMed 34874893Gottgens I, Oertelt-Prigione S. The Application of Human-Centered Design Approaches in Health Research and Innovation: A Narrative Review of Current Practices. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28102. doi: 10.2196/28102.
- Background: PubMed 32469315Almohanna AA, Win KT, Meedya S. Effectiveness of Internet-Based Electronic Technology Interventions on Breastfeeding Outcomes: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17361. doi: 10.2196/17361.
- Background: PubMed 29343463Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873.
- BackgroundLeón-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
- BackgroundDarias AG. Evaluation of the "sponsor a first-time mother" intervention program in the promotion of breastfeeding [Internet]. [San Cristóbal de La Laguna]: University of La Laguna; 2017 [cited 2021 Feb 27]. Available from: https://dialnet.unirioja.es/servlet/tesis?codigo=236035
- BackgroundSierra G. Milk donor women. Characterization of the population and study of hygiene measures for milk expression [PhD thesis]. Madrid: Complutense University of Madrid; 2017 [cited 2024 May 22]. Available from: https://eprints.ucm.es/id/eprint/41442/1/T38431.pdf
- Background: PubMed 11236719Heinig MJ. Host defense benefits of breastfeeding for the infant. Effect of breastfeeding duration and exclusivity. Pediatr Clin North Am. 2001 Feb;48(1):105-23, ix. doi: 10.1016/s0031-3955(05)70288-1.
- Background: PubMed 22371471Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
- Background: PubMed 31968617Wicinski M, Sawicka E, Gebalski J, Kubiak K, Malinowski B. Human Milk Oligosaccharides: Health Benefits, Potential Applications in Infant Formulas, and Pharmacology. Nutrients. 2020 Jan 20;12(1):266. doi: 10.3390/nu12010266.
- BackgroundGómez García GZ, Kikukawa Poma KY. Beliefs, attitudes and practices regarding breast milk donation to the human milk bank in postpartum women at the Hospital Nacional Docente Madre Niño San Bartolomé, September to December 2019. Lima: Universidad Científica del Sur. 2020. Available from: https://repositorio.cientifica.edu.pe/handle/20.500.12805/924
- Background: PubMed 33319403Padro-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on human milk donation via a mobile app Amamantapp and Education via printed leaflets in people with Health Knowledge Attitudes and Practice and Breast Feeding, run by National University of San Marcos, Peru at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Change in Knowledge Scores Regarding Human Milk Donation on a KAP Questionnaire in Breastfeeding Mothers by Study Groups at 60 Days (time frame: Baseline and post-intervention at 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07477041, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.