- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426185
Smartphone-Based Breastfeeding Counselling Study (Breastfeeding)
The Effect of Breastfeeding Counselling With Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration and Problems
Study Overview
Status
Detailed Description
Breastfeeding provides significant health benefits for both mothers and infants; however, low breastfeeding self-efficacy and insufficient professional support remain major barriers to sustained breastfeeding. Mobile health (mHealth) interventions offer accessible and continuous counselling opportunities, particularly during the early postpartum period when breastfeeding problems are most common. This study was designed to evaluate the effectiveness of a smartphone application-based breastfeeding counselling program in improving breastfeeding outcomes among primiparous women.
This randomized controlled trial was conducted at a Training and Research Hospital in Turkey between January 15, 2022, and March 1, 2022. A total of 100 primiparous women were initially randomized, and 60 participants completed the study. Women in the intervention group received access to a smartphone application that included evidence-based breastfeeding education videos, motivational messages, and an interactive "Ask Me" platform for continuous counselling. Motivational messages were sent daily during the first month and weekly from the second to the sixth month. The control group received routine postpartum care.
This study was registered retrospectively. Participant enrollment and data collection were completed before trial registration due to lack of awareness of the prospective registration requirement at the time of study initiation. The study was conducted with ethics committee approval and in accordance with institutional and ethical standards. The trial was registered to ensure transparency and public accessibility of the study protocol and results.
Breastfeeding self-efficacy, breastfeeding-related problems, and breastfeeding duration were assessed at multiple follow-up points up to six months postpartum using validated scales. The study aimed to determine whether continuous digital counselling improves maternal confidence, reduces breastfeeding problems, and increases breastfeeding continuation rates compared with standard care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Izmir, Turkey (Türkiye), 35665
- Bakırçay University Çiğli Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women who agree to participate in the study,
- Aged 18 years or older,
- In the early postpartum period (first 24 hours),
- Able to speak and understand Turkish,
- Possessing a smartphone (ANDROID) and able to use it,
- Who gave birth between 36 and 40 weeks of gestation,
Exclusion Criteria:
- Women who have had a breast infection during pregnancy,
- Women whose baby has an anomaly in the mouth region,
- Women who have communication difficulties,
- Women with a history of breast cancer,
- Women who have given birth multiple times,
- Women with multiple pregnancies,
- Women with a premature baby,
- Women whose baby has neonatal jaundice have been excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention group
Participants received breastfeeding counselling via smartphone application including video education, motivational messages, and remote support for six months.
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Video education,motivational messages and remote support for six months.
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Other: Control Group
Participants received routine postpartum breastfeeding care.
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Standart postpartum breastfeedingcare provided by hospital staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) total score
Time Frame: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
|
The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) is a validated 14-item instrument that measures maternal confidence in breastfeeding.
Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
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Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Problems Evaluation Scale total Score
Time Frame: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
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The Breastfeeding Problems Evaluation Scale is used to assess the severity of difficulties experienced by mothers related to breastfeeding.
Total scores range from 18 to 90, with higher scores indicating greater severity of breastfeeding problems.
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Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
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|
Breastfeeding duration (Breastfeeding ContinuationRate)
Time Frame: 6monts postpartum
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Breastfeeding duration was assessed as the proportion of mothers who continued any breastfeeding at 6 months postpartum.
Continuation of breastfeeding was determined based on maternal self-report during follow-up.
Higher proportions indicate longer breastfeeding duration
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6monts postpartum
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK-2022
- Decision no: 20-8.1T/24 (Other Identifier: Ege University Faculty of Medicine Clinical Research Ethics Committee Approval)
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
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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