NCT07478341

Brief Summary

This randomized controlled study aims to examine the effect of individualized hybrid breastfeeding education provided during late pregnancy on antenatal attachment and breastfeeding behaviors among first-time mothers. Participants will be randomly assigned to either the intervention or control group. Women in the intervention group will receive individualized hybrid breastfeeding education beginning at the 36th week of pregnancy. The program includes a face-to-face individual breastfeeding education session at 36 weeks of pregnancy and a reinforcement and practice session at 38 weeks. Participants will also have access to personalized digital educational materials, short educational videos, and online consultation support. In the postpartum period, participants will receive an online support session during the first week after birth and a follow-up session through online communication or telephone at the sixth postpartum week. The control group will receive routine hospital education during pregnancy. After completion of the study, the same educational materials will be provided to the control group in accordance with ethical principles. Data will be collected using the Demographic Information Form, Breastfeeding Behavior Evaluation Form, Antenatal Attachment Inventory, and Breastfeeding Self-Efficacy Scale. Written informed consent will be obtained from all participants prior to enrollment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

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 Progress78%
Dec 2025Aug 2026

Study Start

First participant enrolled

December 30, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 2, 2026

Last Update Submit

March 13, 2026

Conditions

Breast FeedingExclusive Breast FeedingMaternal-Fetal AttachmentPrimiparity

Keywords

Breastfeeding EducationHybrid EducationPrimiparous WomenAntenatal AttachmentBreastfeeding Self-EfficacyMother-Infant Bonding

Outcome Measures

Primary Outcomes (1)

  • Antenatal Maternal Attachment

    The level of antenatal maternal attachment will be assessed using the Maternal Antenatal Attachment Scale (MAAS). The scale consists of 19 items rated on a 5-point Likert scale. Total scores range from 19 to 95, with higher scores indicating stronger antenatal maternal attachment.

    36-38 weeks of pregnancy

Secondary Outcomes (1)

  • Breastfeeding Self-Efficacy

    At 1 and 6 weeks postpartum

Study Arms (2)

Intervention Group: Individualized Hybrid Breastfeeding Education

EXPERIMENTAL

Primiparous pregnant women in this group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education includes both face-to-face and online components and covers content designed to support breastfeeding knowledge, skills, and mother-infant attachment.

Behavioral: Individualized Hybrid Breastfeeding Education

Control Group: Standard Prenatal Care

NO INTERVENTION

Primiparous pregnant women in this group will not receive any additional intervention during the study period; they will receive routine prenatal care and standard informational services.

Interventions

Individualized Hybrid Breastfeeding EducationBEHAVIORAL

Primiparous pregnant women in the intervention group will receive an individualized hybrid breastfeeding education program planned for late pregnancy. The education consists of a hybrid structure including face-to-face sessions and online educational materials. The content covers the importance of breastfeeding, breastfeeding techniques, common breastfeeding problems, approaches to support mother-infant attachment, and preparation for the postpartum breastfeeding process. The intervention will be provided in addition to standard prenatal care.

Also known as: Standard Prenatal Care
Intervention Group: Individualized Hybrid Breastfeeding Education

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who are biologically female and currently pregnant will be included in the study. Eligibility will be determined based on participants' self-report and a clinical diagnosis of pregnancy.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years,
  • At 36 weeks of gestation or later,
  • Experiencing their first pregnancy (primiparous),
  • Having a singleton pregnancy,
  • Able to read and write in Turkish and capable of communication,
  • Having access to a smartphone or the internet,
  • Free from any physical or mental health problems that would prevent participation in the education,
  • Willing to voluntarily participate in the study and provide written informed consent.

You may not qualify if:

  • Presence of chronic physical illness or pregnancy complications (e.g., preeclampsia, gestational diabetes),
  • Multiple pregnancy,
  • Gestation earlier than 36 weeks,
  • Inability to actively participate in the education due to communication barriers or cognitive impairment,
  • Lack of access to a smartphone or the internet,
  • Failure to attend any stage of the educational program or voluntary withdrawal from the study,
  • Refusal to participate in the study or failure to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elbistan Devlet Hastanesi

Elbistan, Kahramanmaraş, 46040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Asst. Prof.

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asst. Prof.

CONTACT

3443004901emel_guclu4606@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is planned as an open-label trial. Since the intervention involves an educational program, both participants and implementers need to be aware of their assigned groups. Therefore, no blinding will be applied in this study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will use a parallel assignment model. Primiparous pregnant women will be randomly assigned to either the intervention group or the control group. The intervention group will receive individualized hybrid breastfeeding education during late pregnancy, while the control group will receive routine prenatal care. Participants will remain in their assigned group throughout the study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

January 2, 2026

First Posted

March 17, 2026

Study Start

December 30, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) from this study will not be shared with other researchers. To protect participant confidentiality, the data will be analyzed solely by the research team and will not be shared with third parties.

Locations

TU(1)