Father-Focused Breastfeeding Education and Breastfeeding Outcomes (FBF-EDU)

January 5, 2026 updated by: Timuçin İmdadoğlu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Father-Focused Breastfeeding Education
Fathers receive a brief, structured breastfeeding support education in addition to routine care.
Behavioral: Father-Focused Breastfeeding Education
A short, face-to-face educational session provided to fathers focusing on practical ways to support breastfeeding.
No Intervention: Routine Care
Participants receive routine postnatal care without additional breastfeeding education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant feeding status at 3 months postpartum
Time Frame: 3 months postpartum
Infant feeding status will be assessed at 3 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding.
3 months postpartum
Infant feeding status at 6 months postpartum
Time Frame: 6 months postpartum
Infant feeding status will be assessed at 6 months postpartum and categorized as exclusive breastfeeding, partial breastfeeding, or formula/other feeding.
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timuçin İmdadoğlu

Investigators

  • Principal Investigator: timucin imdadoglu, MD, University of Health Sciences Turkey, Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVIH-2025-FBF-RCT
  • EthicsApproval-2025-502 (Other Identifier: University of Health Sciences Turkey - Sancaktepe Training and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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