BreastfeedingNCT05655364
Development of a Breastfeeding Supportive Mobile Application
A study testing Mobile application in people with Breastfeeding and Self Efficacy, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Self Efficacy, Postpartum
- What is being tested?
- Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 30 Oct 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26040
About this study
Official title: 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:
- Does the breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding-self-efficacy of women?
- 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?
- Does a breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change women's time to breastfeed alone?
- Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding duration of women?
Read the 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.
- Conditions
- Breastfeeding, Self Efficacy, Postpartum
- Being tested
- Mobile application
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
Breastfeeding Supportive Mobile Application
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Mobile application |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing women's breastfeeding-self-efficacy
Changing women's breastfeeding-self-efficacy with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory
Measured: 8 months
Changing the rate of women starting breastfeeding within the first hour after birth
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
Measured: 8 months
Changing the duration of breastfeeding alone
Changing the duration of breastfeeding alone by women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory
Measured: 8 months
Changing the breastfeeding duration of women
Changing the breastfeeding duration of women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start5 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nilufer TOPKARA, Eskisehir Osmangazi University
- Investigators
- Fatma Nilüfer TOPKARA, Dr., Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655364
- Sponsor's protocol ID
- DBSMA
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Breastfeeding Supportive Mobile Application: Examining the Effect of the Application on Breastfeeding Self-Efficacy and Outcomes in Primiparous
- ClinicalTrials.gov ID
- NCT05655364
- Acronym / sponsor ID
- DBSMA
- Conditions
- Breastfeeding, Self Efficacy, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Dec 2022 (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 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:
- Does the breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding-self-efficacy of women?
- 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?
- Does a breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change women's time to breastfeed alone?
- Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding duration of women?
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Mobile application |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Mobile applicationBreastfeeding Supportive Mobile Application | Other | Experimental |
Primary outcome
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
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
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
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.
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 28 Aug 2024.
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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.
Fatma Nilüfer TOPKARA, Dr. principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Breastfeeding and Self Efficacy, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 11 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 28 Aug 2024. 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 Turkey (Türkiye). 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?
Changing women's breastfeeding-self-efficacy (time frame: 8 months). The study lists 4 primary outcomes in all. 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 28 Aug 2024.