Development of a Breastfeeding Supportive Mobile Application

August 26, 2024 updated by: Fatma Nilufer TOPKARA, Eskisehir Osmangazi University

Development of a Breastfeeding Supportive Mobile Application: Examining the Effect of the Application on Breastfeeding Self-Efficacy and Outcomes in Primiparous

This work; The aim of this study was to develop a breastfeeding-supporting mobile application and to determine the effect of this application on breastfeeding self-efficacy and outcomes of primiparous. The research is planned to be carried out in two stages. In the first phase of the research, a mobile breastfeeding application based on Breastfeeding Self-Efficacy Theory will be developed. In the second phase of the study, a single-blind randomized pre-test-post-test control group intervention study design will be used to examine the effect of this developed application on breastfeeding self-efficacy and outcomes of primiparous.

The main questions it aims to answer are:

  1. Does the breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding-self-efficacy of women?
  2. Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the rate of women starting breastfeeding within the first hour after birth?
  3. Does a breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change women's time to breastfeed alone?
  4. Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding duration of women?

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

With the widespread adoption of smartphones and mobile software applications in healthcare delivery, developments in technology have significantly affected healthcare delivery models. Traditionally, only face-to-face interviews with health professionals have begun to be supported by mobile health applications (mHealth applications). An mHealth application refers to a standalone software application that can provide healthcare-related services through the use of portable devices such as smartphones. These applications provide more self-management in different health conditions and make it possible for individuals to access universal information, education and support network "anytime, anywhere" and therefore to receive care at home. Pregnant women and women who have just given birth are among the groups that most need and access health information online. They frequently use online applications to meet their need for information on birth and breastfeeding. In a systematic review of free-access mobile breastfeeding applications, it was revealed that there is a need to design a high-quality and interactive professional breastfeeding application that can encourage long-term breastfeeding behavior. It is thought that these practices have an important place in encouraging and supporting especially first-time mothers to breastfeed.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Eskişehir, Turkey, 26040
        • Eskisehir Osmangazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study,
  • Being 18 years or older (18-45 years old),
  • To know how to read and write in Turkish,
  • Not having a visual-hearing disability,
  • 24-36. to be between weeks of pregnancy,
  • Being primiparous,
  • Single pregnancy,
  • Wanting to breastfeed,
  • Not having received breastfeeding training in any period of pregnancy before,
  • Using a smart phone,
  • Absence of a diagnosed psychiatric illness.

Exclusion Criteria:

  • Women carrying fetus with major anomaly,
  • Women with breastfeeding contraindications,
  • Women with high-risk pregnancies,
  • Women who received advice from physicians not to breastfeed due to their health status, If the baby has any of the infectious or metabolic conditions specified by WHO or the Ministry of Health for which breastfeeding is contraindicated, When a baby with a birth weight of less than 2500 g is born or taken to the neonatal intensive care unit,
  • When a baby with a birth weight over 2500 g is taken to the neonatal intensive care unit due to the week of birth, the mother will continue to receive information from the application, but will be excluded from the analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Experimental: Experimental
Breastfeeding Supportive Mobile Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing women's breastfeeding-self-efficacy
Time Frame: 8 months
Changing women's breastfeeding-self-efficacy with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory
8 months
Changing the rate of women starting breastfeeding within the first hour after birth
Time Frame: 8 months
Changing the rate of women starting breastfeeding within the first hour after birth with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory
8 months
Changing the duration of breastfeeding alone
Time Frame: 8 months
Changing the duration of breastfeeding alone by women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory
8 months
Changing the breastfeeding duration of women
Time Frame: 8 months
Changing the breastfeeding duration of women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fatma Nilüfer TOPKARA, Dr., Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DBSMA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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