- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05655364
Development of a Breastfeeding Supportive Mobile Application
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Eskişehir, Turkey, 26040
- Eskisehir Osmangazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Fatma Nilüfer TOPKARA, Dr., Eskisehir Osmangazi University
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
Other Study ID Numbers
- DBSMA
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.
Clinical Trials on Self Efficacy
-
Brigham and Women's HospitalNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedFall Injury | Falls | Exercise Self-Efficacy | Falls Self-EfficacyUnited States
-
Central South UniversityCompletedSelf Efficacy | Self-management
-
IRCCS Policlinico S. DonatoNot yet recruitingSelf Efficacy | Self Confidence | Anticoagulants
-
Kolding SygehusCompleted
-
The New SchoolUniversity of ZurichCompletedSelf EfficacyUnited States
-
Tuğba SarıCompleted
-
Karolinska InstitutetCompleted
-
Pacific Northwest University of Health SciencesAmerican Association of Colleges of Osteopathic Medicine - AACOMCompleted
-
University of Vic - Central University of CataloniaCompleted
-
Chinese University of Hong KongCompleted
Clinical Trials on Mobile application
-
Marta MarciniakRecruiting
-
Mississippi State UniversityCompleted
-
Mississippi State UniversityAssociation for contextual behavioral scienceCompletedHealth-Related BehaviorUnited States
-
George Washington UniversityMedia RezCompleted
-
University of ReginaCompletedStress | Dementia | Caregiver BurdenCanada
-
University Hospitals Cleveland Medical CenterCompleted
-
Seda ÇETİN AVCIActive, not recruiting
-
University of CadizCompleted
-
Boston Medical CenterBoston Medical Center Food KitchenWithdrawnDiabetes Mellitus, Type 2 | Pre DiabetesUnited States
-
Instituto de investigación e innovación biomédica...Completed