BreastfeedingBreastfeedingNCT07426185
Smartphone-Based Breastfeeding Counselling Study
A study testing Breastfeeding counselling via smartphone application and routine postpartum breastfeeding care in people with Breastfeeding and Postpartum Period, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to evaluate the effect of breastfeeding counselling delivered through a smartphone application on breastfeeding self-efficacy, breastfeeding duration, and breastfeeding-related problems among primiparous women in the postpartum period. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Postpartum Period, Smartphone Application
- What is being tested?
- Breastfeeding counselling via smartphone application and routine postpartum breastfeeding care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 1 Mar 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırçay University Çiğli Training and Research Hospital
Izmir, 35665
About this study
Official title: The Effect of Breastfeeding Counselling With Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration and Problems
This randomized controlled study aimed to evaluate the effect of breastfeeding counselling delivered through a smartphone application on breastfeeding self-efficacy, breastfeeding duration, and breastfeeding-related problems among primiparous women in the postpartum period. A total of 60 women were allocated to either an intervention group receiving app-based counselling and motivational messages or a control group receiving routine postpartum care. Outcomes were assessed at multiple follow-up points up to six months postpartum using validated scales. The study investigated whether continuous mHealth-based support improves breastfeeding outcomes compared with standard care.
Read the 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.
- Being tested
- Breastfeeding counselling via smartphone application, routine postpartum breastfeeding care
- Keywords
- Breastfeeding, breastfeeding problems, breastfeeding duration, self-efficacy, smartphone 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.
Breastfeeding counselling via smartphone applicationBehavioural
Video education,motivational messages and remote support for six months.
routine postpartum breastfeeding careOther
Standart postpartum breastfeedingcare provided by hospital staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Participants received breastfeeding counselling via smartphone application including video education, motivational messages, and remote support for six months. Receives: Behavioral: Breastfeeding counselling via smartphone application |
| Control Group | Other | Participants received routine postpartum breastfeeding care. Receives: Other: routine postpartum breastfeeding care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) total score
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.
Measured: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
Secondary outcomes (2)
Breastfeeding Problems Evaluation Scale total Score
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.
Measured: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum
Breastfeeding duration (Breastfeeding ContinuationRate)
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
Measured: 6monts postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start15 Jan 2022
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants were randomly assigned to either the intervention group receiving smartphone application-based breastfeeding counselling or the control group receiving routine postpartum care. Both groups were followed concurrently for six months postpartum, and outcomes were compared between groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna KAYA IBIS, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426185
- Sponsor's protocol ID
- BK-2022
- Other IDs
- Decision no: 20-8.1T/24
- Acronym
- Breastfeeding
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (de-identified) that underlie the results reported in this study will be made available upon reasonable request to the corresponding author. Data will be shared after publication, in accordance with institutional policies and ethical approval, and only for scientific research purposes.
Publications
Ibis BK, Ertem G. The Effect of Breastfeeding Counseling with Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration, and Problems. Niger J Clin Pract. 2026 Apr 1;29(4):390-400. doi: 10.4103/njcp.njcp_506_25. Epub 2026 Apr 30.
PubMed 42085080
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Counselling With Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration and Problems
- ClinicalTrials.gov ID
- NCT07426185
- Acronym / sponsor ID
- Breastfeeding / BK-2022
- Keywords
- Breastfeeding, breastfeeding problems, breastfeeding duration, self-efficacy, smartphone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 23 Feb 2026 (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 randomized controlled study aimed to evaluate the effect of breastfeeding counselling delivered through a smartphone application on breastfeeding self-efficacy, breastfeeding duration, and breastfeeding-related problems among primiparous women in the postpartum period. A total of 60 women were allocated to either an intervention group receiving app-based counselling and motivational messages or a control group receiving routine postpartum care. Outcomes were assessed at multiple follow-up points up to six months postpartum using validated scales. The study investigated whether continuous mHealth-based support improves breastfeeding outcomes compared with standard care.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the intervention group receiving smartphone application-based breastfeeding counselling or the control group receiving routine postpartum care. Both groups were followed concurrently for six months postpartum, and outcomes were compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Behavioral: Breastfeeding counselling via smartphone applicationParticipants received breastfeeding counselling via smartphone application including video education, motivational messages, and remote support for six months. |
| Control Group | Other | Other: routine postpartum breastfeeding careParticipants received routine postpartum breastfeeding care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Breastfeeding counselling via smartphone applicationVideo education,motivational messages and remote support for six months. | Behavioural | Intervention group |
| routine postpartum breastfeeding careStandart postpartum breastfeedingcare provided by hospital staff. | Other | Control Group |
Primary outcome
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.
2 secondary outcomes
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
Breastfeeding duration (Breastfeeding ContinuationRate)
Time frame: 6monts postpartum
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 23 Feb 2026.
- Derived from this study: PubMed 42085080Ibis BK, Ertem G. The Effect of Breastfeeding Counseling with Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration, and Problems. Niger J Clin Pract. 2026 Apr 1;29(4):390-400. doi: 10.4103/njcp.njcp_506_25. Epub 2026 Apr 30.
- Individual participant dataSharing planned: Yes. The individual participant data (de-identified) that underlie the results reported in this study will be made available upon reasonable request to the corresponding author. Data will be shared after publication, in accordance with institutional policies and ethical approval, and only for scientific research purposes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding counselling via smartphone application and routine postpartum breastfeeding care in people with Breastfeeding and Postpartum Period, run by Ege 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 6 inclusion and 8 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 23 Feb 2026. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426185, which also lists 1 linked publication.
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 23 Feb 2026.