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NCT Number: NCT07462975

The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy

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).

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy

Exclusion criteria

  • non-pregnancy

Treatment and study plan

Breastfeeding Education

Behavioral

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.

Primary outcomes

  1. Breastfeeding Health Literacy Scale for Pregnant Women

    Time frame: One year after enrollment.

    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

Sponsors and collaborators

Lead sponsor

Serap Ozturk Altinayak

Other

Registry information

Official study title

The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy: A Randomized Controlled Study

Acronym: EREPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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