NCT07341256

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 3, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Keywords

Father-focused breastfeeding educationPaternal involvementBreastfeeding outcomesPartner Breastfeeding Influence ScalePostpartum period

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month postpartum

Secondary Outcomes (2)

  • Infant feeding status at 3 months postpartum

    3 months postpartum

  • Infant feeding status at 6 months postpartum

    6 months postpartum

Study Arms (2)

Father-Focused Breastfeeding Education

EXPERIMENTAL

Fathers receive a brief, structured breastfeeding support education in addition to routine care.

Behavioral: Father-Focused Breastfeeding Education

Routine Care

NO INTERVENTION

Participants receive routine postnatal care without additional breastfeeding education.

Interventions

A short, face-to-face educational session provided to fathers focusing on practical ways to support breastfeeding.

Father-Focused Breastfeeding Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 21173422BACKGROUND
  • World 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.

    BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • timucin imdadoglu, MD

    University of Health Sciences Turkey, Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

timucin imdadoglu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in parallel to either a father-focused breastfeeding education intervention or a control group receiving routine care.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatrician

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

January 3, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations