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Recruiting NCT07341256

Father-Focused Breastfeeding Education and Breastfeeding Outcomes

No phase Interventional Breastfeeding Paternal Support Exclusive Breastfeeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Father-Focused Breastfeeding Education.
Who it may be relevant to
Registry conditions: Breastfeeding, Paternal Support, Exclusive Breastfeeding. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Father-Focused Breastfeeding Education
    A short, face-to-face educational session provided to fathers focusing on practical ways to support breastfeeding.

Primary outcome measures

  • Paternal breastfeeding support behavior and exclusive breastfeeding at 1 month postpartum [Time frame: 1 month postpartum]
Secondary outcome measures (2)
  • Infant feeding status at 3 months postpartum [Time frame: 3 months postpartum]
  • Infant feeding status at 6 months postpartum [Time frame: 6 months postpartum]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Sancaktepe Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul

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. PMID 21173422
  • 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.

Identifiers

NCT: NCT07341256 · SVIH-2025-FBF-RCT · EthicsApproval-2025-502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗