The Status of Pregnant Women's Breastfeeding Health LiteracyEREPSNCT07462975
The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy
A study testing Breastfeeding Education in people with The Status of Pregnant Women's Breastfeeding Health Literacy, run by Serap Ozturk Altinayak at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- The Status of Pregnant Women's Breastfeeding Health Literacy
- What is being tested?
- Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy
Who cannot join
- non-pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy: A Randomized Controlled Study
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).
Read the 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.
- Being tested
- Breastfeeding Education
- Keywords
- Breastfeeding, Health Literacy, Pregnant School
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Education Group | Experimental | Participants received a structured 2-hour breastfeeding education session delivered by a trained healthcare professional. Receives: Behavioral: Breastfeeding Education |
| Control Group | No intervention | Participants did not receive the breastfeeding education program and received routine care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Nov 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for The Status of Pregnant Women's Breastfeeding Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap Ozturk Altinayak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462975
- Sponsor's protocol ID
- GOKAEK2025/21/22
- Acronym
- EREPS
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H; (HLS-EU) Consortium Health Literacy Project European. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012 Jan 25;12:80. doi: 10.1186/1471-2458-12-80.
PubMed 22276600Sabancı 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 MK, Rozmus CL, LoBiondo-Wood G. Effects of Prenatal Breastfeeding Education on Breastfeeding Duration Beyond 12 Weeks: A Systematic Review. Health Educ Behav. 2024 Oct;51(5):665-676. doi: 10.1177/10901981231220668. Epub 2024 Jan 19.
PubMed 38240358Nutbeam, D. (2022). Health literacy and health promotion: Defining a new agenda. Health Promotion International, 37(1), 1-10.
Rahimli Ocakoglu S, Atak Z, Uyaniklar OO, Ocakoglu G. A Prospective Evaluation of Health Literacy Levels of Pregnant Women in Antenatal Classes: Impact on Delivery Outcomes in Nulliparous and Multiparous Women. Diagnostics (Basel). 2024 Nov 17;14(22):2580. doi: 10.3390/diagnostics14222580.
PubMed 39594246Koh, 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Receiving Education in Pregnancy School on Pregnant Women's Breastfeeding Health Literacy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07462975
- Acronym / sponsor ID
- EREPS / GOKAEK2025/21/22
- Keywords
- Breastfeeding, Health Literacy, Pregnant School
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Serap Ozturk AltinayakUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Education Group | Experimental | Behavioral: Breastfeeding EducationParticipants received a structured 2-hour breastfeeding education session delivered by a trained healthcare professional. |
| Control Group | No intervention | –Participants did not receive the breastfeeding education program and received routine care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnancy
Key exclusion criteria (1 listed)
- non-pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding EducationThis 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. | Behavioural | Breastfeeding Education Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- BackgroundÖzdamar, K. (2003). Biostatistics with SPSS Statistical Package for the Social Sciences. Kaan Publishing.
- BackgroundZhao, 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.
- BackgroundYumrukaya, 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.
- BackgroundWorld Health Organization. (2023). Infant and young child feeding: Key facts. WHO Publications.
- BackgroundTürk, 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: PubMed 22276600Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, Brand H; (HLS-EU) Consortium Health Literacy Project European. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012 Jan 25;12:80. doi: 10.1186/1471-2458-12-80.
- BackgroundSabancı 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.
- BackgroundÖzşahin, 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
- BackgroundÖzkan, 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.
- BackgroundÖnder, 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: PubMed 38240358Oggero MK, Rozmus CL, LoBiondo-Wood G. Effects of Prenatal Breastfeeding Education on Breastfeeding Duration Beyond 12 Weeks: A Systematic Review. Health Educ Behav. 2024 Oct;51(5):665-676. doi: 10.1177/10901981231220668. Epub 2024 Jan 19.
- BackgroundNutbeam, D. (2022). Health literacy and health promotion: Defining a new agenda. Health Promotion International, 37(1), 1-10.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding Education in people with The Status of Pregnant Women's Breastfeeding Health Literacy, run by Serap Ozturk Altinayak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Health Literacy Scale for Pregnant Women (time frame: One year after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07462975, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.