BreastfeedingFBF-EDUNCT07341256
Father-Focused Breastfeeding Education and Breastfeeding Outcomes
A study testing Father-Focused Breastfeeding Education in people with Breastfeeding and Paternal Support, run by Timuçin İmdadoğlu at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding is recommended as the optimal feeding method for infants during the first six months of life. Support from fathers or partners plays an important role in initiating and maintaining breastfeeding. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Paternal Support, Exclusive Breastfeeding
- What is being tested?
- Father-Focused Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fathers or partners aged 18 years or older.
- Fathers or partners of healthy term newborns (≥37 weeks gestation).
- Newborns without major congenital anomalies or chronic medical conditions.
- Fathers or partners present during the early postnatal period.
- Ability to understand and communicate in Turkish.
- Provision of written informed consent.
Who cannot join
- Fathers or partners of preterm infants (<37 weeks gestation).
- Newborns requiring neonatal intensive care unit admission.
- Newborns with major congenital anomalies or severe medical conditions.
- Fathers or partners unable to complete follow-up assessments.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul
timucin imdadoglu, MD, +90 535 742 6892, dr.timucini@gmail.com
About this study
Official title: Effect of a Short Postpartum Father-Focused Breastfeeding Education on Paternal Support Behaviors and Breastfeeding Outcomes at 1, 3, and 6 Months: A Randomized Controlled Trial
Breastfeeding is recommended as the optimal feeding method for infants during the first six months of life. Support from fathers or partners plays an important role in initiating and maintaining breastfeeding. However, most breastfeeding education programs mainly focus on mothers, and structured education directed to fathers is limited.
This study aims to evaluate the effect of a short, structured, father-focused breastfeeding education given shortly after birth on paternal support behaviors and breastfeeding outcomes. Fathers of healthy term newborns will be randomly assigned to receive either a brief breastfeeding support education or routine care. Paternal support behaviors will be assessed using a validated questionnaire, and infant feeding outcomes will be evaluated during follow-up.
The results of this study may help improve breastfeeding support strategies by involving fathers more actively in the early postnatal period.
Read the detailed description
This is a single-center, prospective, randomized controlled trial conducted at Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital in Istanbul, Turkey. The study evaluates the impact of a short, structured, father-focused breastfeeding education delivered in the early postpartum period on paternal breastfeeding support behaviors and infant feeding outcomes.
Fathers or partners of term, clinically stable newborns who are present in the hospital within 24 to 48 hours after birth and who provide written informed consent are eligible for participation. After baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group.
At baseline, sociodemographic data are collected, and paternal breastfeeding support behavior is assessed using the Turkish version of the Partner Breastfeeding Influence Scale (PBIS-TR). Fathers in the intervention group receive a brief, face-to-face breastfeeding support education lasting approximately 8 to 10 minutes. The education is based on international breastfeeding recommendations and focuses on practical ways fathers can support breastfeeding. The control group receives routine clinical care without additional intervention.
Paternal breastfeeding support behavior is reassessed at one month postpartum. Infant feeding status is evaluated at 1, 3, and 6 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding. Data are analyzed to compare paternal support behaviors and breastfeeding outcomes between the two study groups.
This study aims to provide evidence on the effectiveness of early, father-focused breastfeeding education in improving breastfeeding support and outcomes.
- Conditions
- Breastfeeding, Paternal Support, Exclusive Breastfeeding
- Being tested
- Father-Focused Breastfeeding Education
- Keywords
- Father-focused breastfeeding education, Paternal involvement, Breastfeeding outcomes, Partner Breastfeeding Influence Scale, Postpartum period
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Father-Focused Breastfeeding EducationBehavioural
A short, face-to-face educational session provided to fathers focusing on practical ways to support breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Father-Focused Breastfeeding Education | Experimental | Fathers receive a brief, structured breastfeeding support education in addition to routine care. Receives: Behavioral: Father-Focused Breastfeeding Education |
| Routine Care | No intervention | Participants receive routine postnatal care without additional breastfeeding education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paternal breastfeeding support behavior and exclusive breastfeeding at 1 month postpartum
Paternal breastfeeding support behavior will be assessed using the Turkish version of the Partner Breastfeeding Influence Scale (PBIS-TR). Infant feeding status at 1 month postpartum will be recorded and categorized as exclusive breastfeeding or non-exclusive breastfeeding.
Measured: 1 month postpartum
Secondary outcomes (2)
Infant feeding status at 3 months postpartum
Infant feeding status will be assessed at 3 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding.
Measured: 3 months postpartum
Infant feeding status at 6 months postpartum
Infant feeding status will be assessed at 6 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start3 Jan 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in parallel to either a father-focused breastfeeding education intervention or a control group receiving routine care.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Timuçin İmdadoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timuçin İmdadoğlu, Saglik Bilimleri Universitesi
- Investigators
- timucin imdadoglu, MD, Principal investigator, University of Health Sciences Turkey, Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341256
- Sponsor's protocol ID
- SVIH-2025-FBF-RCT
- Other IDs
- EthicsApproval-2025-502
- Acronym
- FBF-EDU
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rempel LA, Rempel JK. The breastfeeding team: the role of involved fathers in the breastfeeding family. J Hum Lact. 2011 May;27(2):115-21. doi: 10.1177/0890334410390045. Epub 2010 Dec 20.
PubMed 21173422World Health Organization. Implementation guidance: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services - the revised Baby-friendly Hospital Initiative 2018. Geneva: World Health Organization; 2023.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Short Postpartum Father-Focused Breastfeeding Education on Paternal Support Behaviors and Breastfeeding Outcomes at 1, 3, and 6 Months: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341256
- Acronym / sponsor ID
- FBF-EDU / SVIH-2025-FBF-RCT
- Conditions
- Breastfeeding, Paternal Support, Exclusive Breastfeeding
- Keywords
- Father-focused breastfeeding education, Paternal involvement, Breastfeeding outcomes, Partner Breastfeeding Influence Scale, Postpartum period
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Timuçin İmdadoğluUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 14 Jan 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.
Breastfeeding is recommended as the optimal feeding method for infants during the first six months of life. Support from fathers or partners plays an important role in initiating and maintaining breastfeeding. However, most breastfeeding education programs mainly focus on mothers, and structured education directed to fathers is limited.
This study aims to evaluate the effect of a short, structured, father-focused breastfeeding education given shortly after birth on paternal support behaviors and breastfeeding outcomes. Fathers of healthy term newborns will be randomly assigned to receive either a brief breastfeeding support education or routine care. Paternal support behaviors will be assessed using a validated questionnaire, and infant feeding outcomes will be evaluated during follow-up.
The results of this study may help improve breastfeeding support strategies by involving fathers more actively in the early postnatal period.
Detailed description
This is a single-center, prospective, randomized controlled trial conducted at Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital in Istanbul, Turkey. The study evaluates the impact of a short, structured, father-focused breastfeeding education delivered in the early postpartum period on paternal breastfeeding support behaviors and infant feeding outcomes.
Fathers or partners of term, clinically stable newborns who are present in the hospital within 24 to 48 hours after birth and who provide written informed consent are eligible for participation. After baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group.
At baseline, sociodemographic data are collected, and paternal breastfeeding support behavior is assessed using the Turkish version of the Partner Breastfeeding Influence Scale (PBIS-TR). Fathers in the intervention group receive a brief, face-to-face breastfeeding support education lasting approximately 8 to 10 minutes. The education is based on international breastfeeding recommendations and focuses on practical ways fathers can support breastfeeding. The control group receives routine clinical care without additional intervention.
Paternal breastfeeding support behavior is reassessed at one month postpartum. Infant feeding status is evaluated at 1, 3, and 6 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding. Data are analyzed to compare paternal support behaviors and breastfeeding outcomes between the two study groups.
This study aims to provide evidence on the effectiveness of early, father-focused breastfeeding education in improving breastfeeding support and outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in parallel to either a father-focused breastfeeding education intervention or a control group receiving routine care.
| Arm | Type | Receives |
|---|---|---|
| Father-Focused Breastfeeding Education | Experimental | Behavioral: Father-Focused Breastfeeding EducationFathers receive a brief, structured breastfeeding support education in addition to routine care. |
| Routine Care | No intervention | –Participants receive routine postnatal care without additional breastfeeding education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fathers or partners aged 18 years or older.
- Fathers or partners of healthy term newborns (≥37 weeks gestation).
- Newborns without major congenital anomalies or chronic medical conditions.
- Fathers or partners present during the early postnatal period.
- Ability to understand and communicate in Turkish.
Key exclusion criteria (5 listed)
- Fathers or partners of preterm infants (<37 weeks gestation).
- Newborns requiring neonatal intensive care unit admission.
- Newborns with major congenital anomalies or severe medical conditions.
- Fathers or partners unable to complete follow-up assessments.
- Refusal or inability to provide informed consent.
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 |
|---|---|---|
| Father-Focused Breastfeeding EducationA short, face-to-face educational session provided to fathers focusing on practical ways to support breastfeeding. | Behavioural | Father-Focused Breastfeeding Education |
Primary outcome
Paternal breastfeeding support behavior and exclusive breastfeeding at 1 month postpartum
Time frame: 1 month postpartum
Paternal breastfeeding support behavior will be assessed using the Turkish version of the Partner Breastfeeding Influence Scale (PBIS-TR). Infant feeding status at 1 month postpartum will be recorded and categorized as exclusive breastfeeding or non-exclusive breastfeeding.
2 secondary outcomes
Infant feeding status at 3 months postpartum
Time frame: 3 months postpartum
Infant feeding status at 6 months postpartum
Time frame: 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 21173422Rempel LA, Rempel JK. The breastfeeding team: the role of involved fathers in the breastfeeding family. J Hum Lact. 2011 May;27(2):115-21. doi: 10.1177/0890334410390045. Epub 2010 Dec 20.
- BackgroundWorld Health Organization. Implementation guidance: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services - the revised Baby-friendly Hospital Initiative 2018. Geneva: World Health Organization; 2023.
- Individual participant dataSharing planned: No
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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.
timucin imdadoglu, MD principal investigator
University of Health Sciences Turkey, Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Father-Focused Breastfeeding Education in people with Breastfeeding and Paternal Support, run by Timuçin İmdadoğlu 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 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: looking for participants now, as of the sponsor's last update on 14 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact timucin imdadoglu, MD (+90 535 742 6892, dr.timucini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal breastfeeding support behavior and exclusive breastfeeding at 1 month postpartum (time frame: 1 month 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 NCT07341256, which also lists 2 linked publications.
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 14 Jan 2026.