- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06862661
Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool (A Mixed-Method)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pampanga
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Angeles City, Pampanga, Philippines, 2009
- Angeles University Foundation, Mac Arthur Highway
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Impact of LactApp on Breastfeeding Self-Efficacy in Filipino Mothers
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From enrollment to the end of the intervention at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maternal Confidence in Breastfeeding
Time Frame: Four weeks after intervention to the end of 3 months.
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Assesses mothers' self-reported confidence in initiating and sustaining breastfeeding.
Data will be collected through semi-structured interviews.
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Four weeks after intervention to the end of 3 months.
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Decision-Making in Breastfeeding Practices
Time Frame: Four weeks after intervention to the end of 3 months.
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Evaluates the factors influencing mothers' feeding decisions, including the role of informational support provided by LactApp.
Data will be collected through semi-structured interviews.
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Four weeks after intervention to the end of 3 months.
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Sense of Empowerment
Time Frame: Four weeks after intervention to the end of 3 months.
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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.
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Four weeks after intervention to the end of 3 months.
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Identification of Barriers
Time Frame: Four weeks after intervention to the end of 3 months.
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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.
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Four weeks after intervention to the end of 3 months.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-CON-Faculty-004 (Other Identifier: Angeles University Foundation Ethics Review Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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