NCT07295639

Brief Summary

The aim of this interventional clinical trial is to assess whether a mobile-based antenatal education programme for expectant fathers has a positive effect on father-infant bonding, stress levels, and breastfeeding attitudes. The study aims to answer the following main questions: Does participation in a mobile-based prenatal education programme strengthen fathers' emotional bonds with their babies? Does the education reduce fathers' stress levels during the prenatal and postnatal periods? Does it increase the father's knowledge and supportive attitude towards breastfeeding? Researchers will compare whether there are measurable differences in attachment, stress, and breastfeeding attitudes between the intervention group (fathers receiving mobile-based education) and the control group (fathers receiving standard routine information). Participants: Will complete pre- and post-intervention questionnaires assessing attachment, stress, and breastfeeding attitudes. The intervention group will have access to a six-module mobile application covering topics such as infant care, nutrition, sleep routines, health and safety, emotional development, and daily care practices. The study will be conducted with fathers aged 19-65 who became fathers within the last month and voluntarily agreed to participate.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress39%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

November 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 19, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

father-infant bondingpaternal stressbreastfeeding attitudesmobile-based education

Outcome Measures

Primary Outcomes (4)

  • Change in Paternal Stress Levels

    Paternal stress levels measured using the State-Trait Anxiety Inventory (STAI-State Subscale). A total score of 0-19 indicates no anxiety, a total score of 20-39 indicates mild anxiety, a total score of 40-59 indicates moderate anxiety, and a total score of 60-79 indicates severe anxiety. A total score of 60 or above indicates that the individual requires professional help.

    Baseline (Day 1) and Post-Intervention (8 weeks after baseline)

  • Change in Father-Infant Bonding

    Father-infant bonding measured using the Father-Infant Bonding Scale. High scores on the scale indicate a high level of attachment.

    Baseline (Day 1) and Post-Intervention (8 weeks after baseline)

  • Change in Breastfeeding Attitudes and Participation

    Fathers' attitudes and participation related to breastfeeding measured using the Fathers' Breastfeeding Attitude and Participation Scale. The total score under the sub-dimension of Fathers' Attitude Towards Breastfeeding ranges from 14 to 70, and the cut-off point for the scale is 58. The total score under the sub-dimension of Fathers' Participation in Breastfeeding ranges from 14 to 70, and the cut-off point for the scale is 58. High scores indicate high attitude and participation.

    Baseline (Day 1) and Post-Intervention (8 weeks after baseline)

  • Change in Marital Satisfaction Levels

    Marital satisfaction measured using the Marital Satisfaction Scale. The total score that can be obtained from the scale, which consists of a single subscale, ranges from 12 to 60 points. There are no reverse items on the scale. An increase in the score obtained from the scale indicates a high level of marital satisfaction.

    Baseline (Day 1) and Post-Intervention (8 weeks after baseline)

Study Arms (2)

Mobile-Based Prenatal Education for Expectant Fathers

EXPERIMENTAL

Fathers in this arm will receive access to a six-module mobile-based prenatal education programme covering infant care, nutrition and feeding, sleep routines, health and safety practices, emotional and social development, and daily care skills. They will complete pre- and post-intervention questionnaires on father-infant bonding, stress levels, and breastfeeding attitudes.

Behavioral: Mobile-based application

Standard Routine Information for Expectant Fathers

NO INTERVENTION

Fathers in this arm will receive standard routine information provided in usual care. They will not have access to the mobile-based education programme. They will complete the same pre- and post-intervention questionnaires on father-infant bonding, stress levels, and breastfeeding attitudes during the same time intervals as the intervention group.

Interventions

The intervention is a six-module mobile-based training programme developed specifically for expectant fathers. The modules cover baby care, nutrition, sleep patterns, health and safety, emotional development and daily care. The aim is to strengthen the father-baby bond, reduce stress levels and develop a positive attitude towards breastfeeding.

Mobile-Based Prenatal Education for Expectant Fathers

Eligibility Criteria

Age19 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 19 and 65 years
  • First-time father
  • Has become a father within the last month
  • Has a healthy newborn without congenital anomalies or chronic illnesses
  • Does not have a premature or low-birth-weight baby
  • Has not become a father through adoption
  • Owns a mobile phone capable of accessing the mobile-based application
  • Has an Android or iOS operating system
  • Has not received any infant care training within the last 6 months
  • Has no physical or mental disability that would prevent viewing, hearing, or understanding the research questions or educational content
  • Voluntarily agrees to participate in the research

You may not qualify if:

  • Declines to participate in the research
  • Does not own a smartphone
  • Cannot use mobile applications
  • Has a physical or mental condition that prevents completing the questionnaires
  • Has a baby with congenital anomalies or chronic medical conditions
  • Has a premature or low-birth-weight baby
  • Has received infant care training within the last 6 months
  • Has adopted a child
  • Is outside the 19-65 age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Islam Science and Technology University

Şahinbey, Gaziantep, Turkey (Türkiye)

Location

Related Publications (3)

  • Bakker CJ, Wyatt TH, Breth MC, Gao G, Janeway LM, Lee MA, Martin CL, Tiase VL. Nurses' Roles in mHealth App Development: Scoping Review. JMIR Nurs. 2023 Oct 17;6:e46058. doi: 10.2196/46058.

    PMID: 37847533BACKGROUND
  • Bich TH, Long TK, Hoa DP. Community-based father education intervention on breastfeeding practice-Results of a quasi-experimental study. Matern Child Nutr. 2019 Jan;15 Suppl 1(Suppl 1):e12705. doi: 10.1111/mcn.12705.

    PMID: 30748110BACKGROUND
  • Challacombe FL, Pietikainen JT, Kiviruusu O, Saarenpaa-Heikkila O, Paunio T, Paavonen EJ. Paternal perinatal stress is associated with children's emotional problems at 2 years. J Child Psychol Psychiatry. 2023 Feb;64(2):277-288. doi: 10.1111/jcpp.13695. Epub 2022 Oct 10.

    PMID: 36215991BACKGROUND

MeSH Terms

Conditions

Breast FeedingHealth Education

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Sebahat Kuşlu, MSc

    Gaziantep Islam Science and Technology University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebahat Kuşlu, Masters

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study is open-label for participants and investigators. However, the statistician responsible for data analysis will be blinded to group assignments to reduce potential bias in outcome evaluation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two parallel groups: an intervention group receiving mobile-based prenatal education for expectant fathers, and a control group receiving routine prenatal information. The outcomes of both groups will be compared after the intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 19, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The ethics committee, confidentiality or national legislation deem sharing inappropriate.

Locations