- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462975
The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy (EREPS)
The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
F.2 Subject
Breastfeeding is one of the most effective natural methods for protecting maternal and infant health. The World Health Organization (WHO, 2023) recommends exclusive breastfeeding for the first six months after birth and emphasizes that breastfeeding education provided during this period positively influences mothers' breastfeeding behaviors. However, studies indicate that many mothers lack adequate breastfeeding knowledge and health literacy (Nutbeam, 2022). Therefore, it is important to examine the impact of education provided during pregnancy-particularly "Pregnancy School" (antenatal education programs)-on breastfeeding health literacy.
Health literacy refers to individuals' capacity to access, understand, evaluate, and apply health-related information (Sørensen et al., 2012). Breastfeeding health literacy is a specific sub-dimension of this concept and encompasses a mother's ability to access breastfeeding-related information, interpret it accurately, and translate it into appropriate behaviors (Koh et al., 2020). The literature shows that mothers with higher levels of breastfeeding health literacy are more successful in initiating breastfeeding early and maintaining it for longer durations (Zhao et al., 2021).
Studies conducted in Türkiye have shown that women who attend pregnancy schools have significantly higher levels of breastfeeding knowledge and self-confidence compared to those who do not (Aydın & Arslan, 2022). Similarly, an international study by Oggero et al. (2024) reported that prenatal breastfeeding education increases both the duration of breastfeeding and maternal self-efficacy in the postpartum period. While the effects of pregnancy school education on breastfeeding knowledge and self-efficacy have been addressed in various studies, there are no systematic investigations in the literature that evaluate the concept of breastfeeding health literacy in relation to participation in pregnancy schools. Most existing studies focus on general health literacy or breastfeeding knowledge levels and do not comprehensively address the multidimensional structure of breastfeeding health literacy, including the dimensions of accessing, understanding, evaluating, and applying information (Nutbeam, 2022; Sørensen et al., 2012).
In this context, the present study aims to both fill an important gap in the national literature and provide new evidence on the impact of antenatal education on breastfeeding behaviors.
F.2. Aim
The aim of this study is to evaluate the relationship between participation in pregnancy school (antenatal education programs) and the level of breastfeeding health literacy among pregnant women.
F.3. Scope
The effects of education provided in pregnancy schools on breastfeeding knowledge and self-efficacy levels have been addressed in various studies. However, there are no studies in the literature that systematically evaluate the concept of breastfeeding health literacy in relation to participation in pregnancy schools. Most existing studies focus on general health literacy or breastfeeding knowledge levels and do not address breastfeeding health literacy in a comprehensive manner that includes the dimensions of accessing, understanding, evaluating, and applying information (Nutbeam, 2022; Sørensen et al., 2012).
The study by Aydın and Arslan (2022) examined the effect of prenatal breastfeeding education on knowledge levels but did not include the health literacy dimension. On the other hand, the international study entitled "A Prospective Evaluation of Health Literacy Levels of Pregnant Women in Antenatal Classes" (Kowalska et al., 2024) evaluated the relationship between general health literacy and birth outcomes but did not conduct a breastfeeding-specific assessment.
Therefore, the present study has the potential to be one of the first studies to directly examine the effect of participation in pregnancy school programs on breastfeeding health literacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Samsun, Turkey (Türkiye)
- Ondokuz Mayıs University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnancy
Exclusion Criteria:
- non-pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Breastfeeding Education Group
Participants received a structured 2-hour breastfeeding education session delivered by a trained healthcare professional.
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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.
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No Intervention: Control Group
Participants did not receive the breastfeeding education program and received routine care only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breastfeeding Health Literacy Scale for Pregnant Women
Time Frame: One year after enrollment.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Özdamar, K. (2003). Biostatistics with SPSS Statistical Package for the Social Sciences. Kaan Publishing.
- 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.
- 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.
- World Health Organization. (2023). Infant and young child feeding: Key facts. WHO Publications.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Oggero, M. K., et al. (2024). Effects of prenatal breastfeeding education on breastfeeding duration and self-efficacy: A systematic review. Midwifery, 125, 103805.
- Nutbeam, D. (2022). Health literacy and health promotion: Defining a new agenda. Health Promotion International, 37(1), 1-10.
- Kowalska, M., et al. (2024). A prospective evaluation of health literacy levels of pregnant women in antenatal classes. Diagnostics, 14(22), 2580.
- 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.
- Erdoğan, S., Nahcivan, N., & Esin, N. (2020). Research in nursing (4th ed.). Nobel Medical Publishing.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK2025/21/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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