NCT07040254

Brief Summary

This randomized controlled trial aims to evaluate the effect of paternal support on breastfeeding adaptation and breastfeeding self-efficacy among mothers attending a structured pregnancy school program. The study is conducted at Zeynep Kamil Women and Children's Diseases Training and Research Hospital in Istanbul, Türkiye, and includes pregnant women and their partners. Participants are assigned to an experimental group (attending the program as a couple) or a control group (mother attends alone) using random allocation. Data are collected through validated self-report scales administered during the postpartum period. The primary outcomes include changes in maternal breastfeeding adaptation and self-efficacy, and paternal breastfeeding self-efficacy. This study addresses a critical gap in perinatal care by actively involving fathers in breastfeeding support and education, aiming to improve breastfeeding outcomes and promote shared parenting roles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

June 18, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

Parental supportbreastfeeding self-efficacybreastfeeding adaptation

Outcome Measures

Primary Outcomes (3)

  • Postpartum Breastfeeding Self-Efficacy Scale-Short Form

    This scale was developed by Dennis in 2003 to assess breastfeeding self-efficacy during the postpartum period and was adapted into Turkish by Aluş et al. (2008) with validity and reliability established (Tokat Aluş et al., 2010). The scale consists of 14 items on a 5-point Likert scale. There are no reverse-scored items, and total scores range from a minimum of 14 to a maximum of 70. Higher scores indicate greater breastfeeding self-efficacy. The Cronbach's alpha coefficient of the original scale was reported as 0.94.

    4 week

  • Breastfeeding Adaptation Scale

    This scale was developed by Sun-Hee Kim (2009) to evaluate adaptation to breastfeeding. The Turkish version was validated by Dinçel and Özdilek (2021). It is a 5-point Likert-type scale consisting of 8 subdimensions. Total scores range from 27 to 135, with higher scores indicating greater adaptation to breastfeeding. The Cronbach's alpha coefficient of the scale was reported as 0.78.

    4 week

  • Breastfeeding Self-Efficacy Scale-Short Form for Fathers

    This scale was developed to assess fathers' perspectives and perceived effectiveness about breastfeeding. The Turkish validity and reliability study was conducted by Kucukoglu et al. (2022). The scale is self-reported, unidimensional, and consists of 14 items rated on a 5-point Likert scale. There are no reverse-scored items, and total scores range from 14 to 70. Higher scores indicate greater paternal breastfeeding self-efficacy. The Cronbach's alpha coefficient of the scale was reported as 0.93.

    4 week

Study Arms (2)

Pregnant women attending the pregnancy school with their spouses

EXPERIMENTAL

Participants in this group attended a six-week structured pregnancy education program together with their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Data on breastfeeding adaptation and self-efficacy were collected from both mothers and fathers during the postpartum period.

Behavioral: Father-Inclusive Antenatal Education Program

Pregnant Women Attending the Pregnancy School Alone

NO INTERVENTION

Participants in this group attended the six-week structured pregnancy education program without their spouses. While the fathers did not participate in the program or receive any intervention, data were collected from both mothers and fathers during the postpartum period. This group served as a control to evaluate the effects of paternal involvement in antenatal education on breastfeeding outcomes.

Interventions

A structured six-week antenatal education program designed for pregnant women and their spouses. The program included sessions on pregnancy care, labor, breastfeeding, newborn care, and postpartum health. Fathers in the intervention group attended the program alongside their partners and were actively engaged in discussions and learning activities related to breastfeeding support. The goal was to enhance paternal awareness and involvement to improve maternal breastfeeding adaptation and both maternal and paternal breastfeeding self-efficacy. No additional materials were provided beyond the scheduled sessions.

Pregnant women attending the pregnancy school with their spouses

Eligibility Criteria

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

You may qualify if:

  • Pregnant women aged 18 to 49 years enrolled in a pregnancy school. Male partners of the enrolled pregnant women, aged 18 to 64 years. Residing in Istanbul during the study period. Able to participate in face-to-face interviews. Able to understand and speak Turkish. Able to communicate via telephone and use digital platforms (e.g., WhatsApp, Telegram, email).
  • No physical or mental disability. Willing to participate and provide signed informed consent.

You may not qualify if:

  • Presence of any physical or mental disability. Unwillingness to participate in the study. Irregular attendance in pregnancy school sessions. Prior participation by either partner in the same pregnancy education program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhN(c) Lecturer

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 27, 2025

Study Start

September 1, 2024

Primary Completion

June 15, 2025

Study Completion

June 18, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Due to institutional policy, the data cannot be shared. The findings will be published in the related scientific article.

Locations