NCT07462975

Brief Summary

This study is planned as a randomized controlled trial with a pre-test-post-test control group design. Participants will be randomly assigned to two groups: an experimental group and a control group. An intervention (education) will be applied to the experimental group, while no intervention will be provided to the control group (Erdoğan, Nahcıvan, \& Esin, 2020).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Expected
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 3, 2026

Last Update Submit

March 6, 2026

Conditions

The Status of Pregnant Women's Breastfeeding Health Literacy

Keywords

BreastfeedingHealth LiteracyPregnant School

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Health Literacy Scale for Pregnant Women

    This scale was developed in Turkish by Özkan and colleagues in 2024. The scale consists of four sub-dimensions and 25 items. The sub-dimensions of the scale are defined as "Breastfeeding Knowledge (items 1-7)," "Access to Breastfeeding Information (items 8-15)," "Evaluation of Breastfeeding Information (items 16-21)," and "Maintaining Breastfeeding (items 22-25)." The scale is a five-point Likert-type scale (1 = "strongly disagree," 2 = "disagree," 3 = "undecided," 4 = "agree," 5 = "strongly agree"). There are no reverse-scored items in the scale. The Cronbach's alpha reliability coefficients of the Breastfeeding Health Literacy Scale for Pregnant Women were found to be 0.95 for the breastfeeding knowledge dimension, 0.92 for access to breastfeeding information, 0.88 for evaluation of breastfeeding information, 0.92 for maintaining breastfeeding, and 0.96 for the total scale. Based on these values, the internal consistency of t

    One year after enrollment.

Study Arms (2)

Breastfeeding Education Group

EXPERIMENTAL

Participants received a structured 2-hour breastfeeding education session delivered by a trained healthcare professional.

Behavioral: Breastfeeding Education

Control Group

NO INTERVENTION

Participants did not receive the breastfeeding education program and received routine care only

Interventions

Breastfeeding EducationBEHAVIORAL

This study is planned as a randomized controlled trial. In the pre-test-post-test control group design, participants are randomly assigned to two groups through a randomization process. These groups are referred to as the experimental group and the control group. While the experimental group receives the intervention (education), no intervention is provided to the control group.

Breastfeeding Education Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy

You may not qualify if:

  • non-pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

Related Publications (16)

  • Özdamar, K. (2003). Biostatistics with SPSS Statistical Package for the Social Sciences. Kaan Publishing.

    BACKGROUND

  • Zhao, L., Chen, M., & Xu, H. (2021). Maternal breastfeeding health literacy and its impact on breastfeeding duration: A cohort study. International Breastfeeding Journal, 16(1), 77.

    BACKGROUND

  • Yumrukaya, Y., & Kartal, Y. A. (2023). Determination of traditional and complementary treatment methods used by women for common pregnancy complaints and their effects on quality of life [Unpublished master's thesis]. University of Health Sciences, Hamidiye Institute of Health Sciences, Department of Midwifery.

    BACKGROUND

  • World Health Organization. (2023). Infant and young child feeding: Key facts. WHO Publications.

    BACKGROUND

  • Türk, Y., & Sis Çelik, A. (2024). Pregnancy complaints according to gestational weeks and number of pregnancies and their effect on quality of life [Unpublished master's thesis]. Atatürk University, Institute of Health Sciences, Department of Obstetrics and Gynecology Nursing.

    BACKGROUND

  • Sørensen, K., Van den Broucke, S., & Fullam, J. (2012). Health literacy and public health: A systematic review and integration of definitions and models. BMC Public Health, 12(1), 80.

    BACKGROUND

  • Sabancı Baransel, E., & Uçar, T. (2021). Physical activity in high-risk pregnancies, well-being in pregnancy, and the effect of pregnancy complaints on quality of life: A comparative study. Anatolian Journal of Health Research, 2(3), 101-106.

    BACKGROUND

  • Özşahin, Z., Aksakal, Z. G., Erdem, N., Koldaş, B., et al. (2022). The effect of adverse childhood experiences on pregnancy complaints and quality of life: A cross-sectional study. İnönü University Journal of Health Services Vocational School, 10(2), 563-576. https://doi.org/10.33715/inonusaglik.1020379

    BACKGROUND

  • Özkan, A., Yılmaz, S., & Kaya, B. (2023). Development and validation of the Breastfeeding Health Literacy Scale for pregnant women. BMC Pregnancy and Childbirth, 23(1), 412.

    BACKGROUND

  • Önder, H., & Arıöz Düzgün, A. (2024). Evaluation of pregnancy complaints, quality of life, and related factors in pregnant women with gestational diabetes [Unpublished master's thesis]. Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Obstetrics and Gynecology Nursing.

    BACKGROUND

  • Oggero, M. K., et al. (2024). Effects of prenatal breastfeeding education on breastfeeding duration and self-efficacy: A systematic review. Midwifery, 125, 103805.

    BACKGROUND

  • Nutbeam, D. (2022). Health literacy and health promotion: Defining a new agenda. Health Promotion International, 37(1), 1-10.

    BACKGROUND

  • Kowalska, M., et al. (2024). A prospective evaluation of health literacy levels of pregnant women in antenatal classes. Diagnostics, 14(22), 2580.

    BACKGROUND

  • Koh, H. K., Rudd, R. E., & Baur, C. (2020). Health literacy as a global public health goal: The case of breastfeeding health literacy. Journal of Health Communication, 25(3), 183-190.

    BACKGROUND

  • Erdoğan, S., Nahcivan, N., & Esin, N. (2020). Research in nursing (4th ed.). Nobel Medical Publishing.

    BACKGROUND

  • Aydın, D., & Arslan, H. (2022). The effect of pregnancy school education on mothers' breastfeeding knowledge and attitudes. Türkiye Klinikleri Journal of Women's Health Nursing, 3(1), 45-53.

    BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

November 15, 2025

Primary Completion

April 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(1)