Breastfeeding EducationA Mixed-MethodNCT06862661
Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool
A study testing Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey. in people with Breastfeeding Education, run by Angeles University Foundation at 1 site in Philippines.
Trial summary
This study aimed to evaluate the effectiveness of LactApp in improving breastfeeding self-efficacy among Filipino mothers. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Education
- What is being tested?
- Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePhilippines
- Study dates
- 25 Sep 2024to 15 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females aged 16-45, including those who are pregnant or have recently given birth (within the last 12 months).
- Females who are currently seeking breastfeeding support and are open to using the LactApp tool.
- Females who are willing to participate in the study and provide informed consent.
Who cannot join
- Females who are not intending to breastfeed.
- Females with significant health issues that may impair their ability to use the LactApp tool or participate in the study.
- Females who are not fluent in the language in which the LactApp tool is provided, making it difficult for them to engage with the content.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Angeles University Foundation, Mac Arthur Highway
Angeles City, Pampanga, 2009
About this study
This study aimed to evaluate the effectiveness of LactApp in improving breastfeeding self-efficacy among Filipino mothers.
Read the detailed description
Breastfeeding is crucial for maternal and child health, but Filipino mothers face significant challenges, worsened by the COVID-19 pandemic, which has limited access to traditional breastfeeding support. This study proposes evaluating the LactApp mobile application as a tool to enhance breastfeeding self-efficacy among Filipino mothers and improve nursing education.
The study's objectives include assessing LactApp's effectiveness in boosting mothers' confidence in breastfeeding and identifying gaps in nursing students' breastfeeding education. A mixed-methods approach will be used, combining quantitative assessments (via the Breastfeeding Self-Efficacy Scale-Short Form) and qualitative focus group discussions with mothers and nursing students. The study will also analyze user engagement and common breastfeeding queries to tailor educational content.
Expected outcomes include empowering nursing students with better breastfeeding knowledge, improving maternal support, and integrating digital tools like LactApp into nursing curricula. Ultimately, the study aims to enhance breastfeeding outcomes for Filipino mothers and contribute to improved maternal and child health in the community.
- Conditions
- Breastfeeding Education
- Being tested
- Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.
- Keywords
- Breastfeeding practices, Breastfeeding self-efficacy, Lactation Support, Maternal Health, Mobile Health Applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.Other
Also called Tracking Tool.
A tool to track breastfeeding frequency, duration, and baby's weight and offers access to a community forum for peer support along with direct consultations with lactation experts.
| Study group | Role | What they receive |
|---|---|---|
| Impact of LactApp on Breastfeeding Self-Efficacy in Filipino Mothers | Experimental | This study focuses on evaluating the impact of the LactApp mobile application on the breastfeeding self-efficacy of Filipino mothers. Participants will complete a pre-test survey using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) to establish baseline confidence levels in breastfeeding. They then used the LactApp tool for 3 months, which provided personalized advice, tracking tools, and educational content. After the intervention, the same survey will be administered as a post-test to measure changes in self-efficacy. Receives: Other: Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breastfeeding self-efficacy
The primary outcome of this study is the enhancement of breastfeeding self-efficacy among Filipino mothers following the use of the LactApp mobile Health tool. This outcome is measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a validated tool designed to assess a mother's confidence in her ability to breastfeed. The BSES-SF consists of 14 items, each scored on a 5-point Likert scale ranging from 1 ("Not at all confident") to 5 ("Always confident"). The total score ranges from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. This scale is widely used in maternal health research to evaluate interventions aimed at improving breastfeeding outcomes.
Measured: From enrollment to the end of the intervention at 3 months
Secondary outcomes (4)
Maternal Confidence in Breastfeeding
Assesses mothers' self-reported confidence in initiating and sustaining breastfeeding. Data will be collected through semi-structured interviews.
Measured: Four weeks after intervention to the end of 3 months.
Decision-Making in Breastfeeding Practices
Evaluates the factors influencing mothers' feeding decisions, including the role of informational support provided by LactApp. Data will be collected through semi-structured interviews.
Measured: Four weeks after intervention to the end of 3 months.
Sense of Empowerment
Assess the extent to which breastfeeding contributes to mothers' feelings of autonomy and overall empowerment in managing their infant's feeding. Data will be collected through semi-structured interviews.
Measured: Four weeks after intervention to the end of 3 months.
Identification of Barriers
Identifies potential barriers to effective use of the LactApp, including issues related to digital literacy and accessibility, which may impact breastfeeding self-efficacy. Data will be collected through semi-structured interviews.
Measured: Four weeks after intervention to the end of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Sep 2024
- Primary completion5 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding EducationStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The intervention involves introducing the LactApp tool to mothers to enhance breastfeeding self-efficacy. Researchers assist participants in downloading and navigating the app, which offers features like daily breastfeeding tips, tracking tools, and expert support. Mothers are encouraged to use the app regularly, with weekly follow-ups to monitor engagement and provide additional support, aiming to improve their breastfeeding experience.
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angeles University Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudena A. Madayag, Angeles University Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862661
- Sponsor's protocol ID
- 2024-CON-Faculty-004
- Other IDs
- 2024-CON-Faculty-004
- Acronym
- A Mixed-Method
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool
- ClinicalTrials.gov ID
- NCT06862661
- Acronym / sponsor ID
- A Mixed-Method / 2024-CON-Faculty-004
- Conditions
- Breastfeeding Education
- Keywords
- Breastfeeding practices, Breastfeeding self-efficacy, Lactation Support, Maternal Health, Mobile Health Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Angeles University FoundationUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (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.
This study aimed to evaluate the effectiveness of LactApp in improving breastfeeding self-efficacy among Filipino mothers.
Detailed description
Breastfeeding is crucial for maternal and child health, but Filipino mothers face significant challenges, worsened by the COVID-19 pandemic, which has limited access to traditional breastfeeding support. This study proposes evaluating the LactApp mobile application as a tool to enhance breastfeeding self-efficacy among Filipino mothers and improve nursing education.
The study's objectives include assessing LactApp's effectiveness in boosting mothers' confidence in breastfeeding and identifying gaps in nursing students' breastfeeding education. A mixed-methods approach will be used, combining quantitative assessments (via the Breastfeeding Self-Efficacy Scale-Short Form) and qualitative focus group discussions with mothers and nursing students. The study will also analyze user engagement and common breastfeeding queries to tailor educational content.
Expected outcomes include empowering nursing students with better breastfeeding knowledge, improving maternal support, and integrating digital tools like LactApp into nursing curricula. Ultimately, the study aims to enhance breastfeeding outcomes for Filipino mothers and contribute to improved maternal and child health in the community.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention involves introducing the LactApp tool to mothers to enhance breastfeeding self-efficacy. Researchers assist participants in downloading and navigating the app, which offers features like daily breastfeeding tips, tracking tools, and expert support. Mothers are encouraged to use the app regularly, with weekly follow-ups to monitor engagement and provide additional support, aiming to improve their breastfeeding experience.
| Arm | Type | Receives |
|---|---|---|
| Impact of LactApp on Breastfeeding Self-Efficacy in Filipino Mothers | Experimental | Other: Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.This study focuses on evaluating the impact of the LactApp mobile application on the breastfeeding self-efficacy of Filipino mothers. Participants will complete a pre-test survey using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) to establish baseline confidence levels in breastfeeding. They then used the LactApp tool for 3 months, which provided personalized advice, tracking tools, and educational content. After the intervention, the same survey will be administered as a post-test to measure changes in self-efficacy. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Females aged 16-45, including those who are pregnant or have recently given birth (within the last 12 months).
- Females who are currently seeking breastfeeding support and are open to using the LactApp tool.
- Females who are willing to participate in the study and provide informed consent.
Key exclusion criteria (3 listed)
- Females who are not intending to breastfeed.
- Females with significant health issues that may impair their ability to use the LactApp tool or participate in the study.
- Females who are not fluent in the language in which the LactApp tool is provided, making it difficult for them to engage with the content.
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 |
|---|---|---|
| Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.Also: Tracking Tool.A tool to track breastfeeding frequency, duration, and baby's weight and offers access to a community forum for peer support along with direct consultations with lactation experts. | Other | Impact of LactApp on Breastfeeding Self-Efficacy in Filipino Mothers |
Primary outcome
Change in breastfeeding self-efficacy
Time frame: From enrollment to the end of the intervention at 3 months
The primary outcome of this study is the enhancement of breastfeeding self-efficacy among Filipino mothers following the use of the LactApp mobile Health tool. This outcome is measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a validated tool designed to assess a mother's confidence in her ability to breastfeed. The BSES-SF consists of 14 items, each scored on a 5-point Likert scale ranging from 1 ("Not at all confident") to 5 ("Always confident"). The total score ranges from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. This scale is widely used in maternal health research to evaluate interventions aimed at improving breastfeeding outcomes.
4 secondary outcomes
Maternal Confidence in Breastfeeding
Time frame: Four weeks after intervention to the end of 3 months.
Decision-Making in Breastfeeding Practices
Time frame: Four weeks after intervention to the end of 3 months.
Sense of Empowerment
Time frame: Four weeks after intervention to the end of 3 months.
Identification of Barriers
Time frame: Four weeks after intervention to the end of 3 months.
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 6 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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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 Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey. in people with Breastfeeding Education, run by Angeles University Foundation at 1 site in Philippines.
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 3 inclusion and 3 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 6 Mar 2025. 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 Philippines. 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. 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?
Change in breastfeeding self-efficacy (time frame: From enrollment to the end of the intervention at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.