NCT06862661

Brief Summary

This study aimed to evaluate the effectiveness of LactApp in improving breastfeeding self-efficacy among Filipino mothers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 20, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

Breastfeeding practicesBreastfeeding self-efficacyLactation SupportMaternal HealthMobile Health Applications

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of the intervention at 3 months

Secondary Outcomes (4)

  • Maternal Confidence in Breastfeeding

    Four weeks after intervention to the end of 3 months.

  • Decision-Making in Breastfeeding Practices

    Four weeks after intervention to the end of 3 months.

  • Sense of Empowerment

    Four weeks after intervention to the end of 3 months.

  • Identification of Barriers

    Four weeks after intervention to the end of 3 months.

Study Arms (1)

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.

Other: Daily Tips and Advice on the use of LactApp m-health tool throughout the breastfeeding journey.

Interventions

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.

Also known as: Tracking Tool.
Impact of LactApp on Breastfeeding Self-Efficacy in Filipino Mothers

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFilipino mothers who were either pregnant or had children under the age of one, was specifically chosen because these groups are most directly impacted by the challenges of breastfeeding and maternal health, and they are the ideal demographic for studying the effectiveness of breastfeeding interventions such as the LactApp tool.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angeles University Foundation, Mac Arthur Highway

Angeles City, Pampanga, 2009, Philippines

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 6, 2025

Study Start

September 25, 2024

Primary Completion

December 5, 2024

Study Completion

December 15, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

IPD used in the results publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 year after publication with no end date
Access Criteria
Access to Individual Participant Data (IPD) and supporting information from the study will be granted to researchers, healthcare professionals, and policymakers with a legitimate interest in maternal healthcare. Interested individuals must demonstrate a clear research purpose, such as conducting secondary analyses or developing new interventions. Authorized users will access anonymized IPD, including demographic information and breastfeeding self-efficacy scores, while ensuring participant privacy. Supporting documentation will consist of the study protocol and data collection tools. Access will be managed through a data-sharing agreement to ensure ethical use. Interested parties must submit a formal request outlining their objectives, which will be reviewed by a data-sharing committee. Once approved, users can access the data via a secure online platform, ensuring responsible utilization that advances research and improves maternal healthcare outcomes.

Locations