BreastfeedingNCT07724509
Effectiveness of a Health Literacy-Based Breastfeeding Education Program
A study testing Routine postpartum breastfeeding care and Experimental in people with Breastfeeding, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of a comprehensive breastfeeding education program based on a health literacy development strategy on maternal and paternal breastfeeding self-efficacy, fathers' breastfeeding support, parental health literacy, and breastfeeding outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Routine postpartum breastfeeding care and Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2025to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers and fathers aged 18-65 years
- Parents of a healthy term infant
- Parents able to read and speak Turkish
- Mothers and fathers without hearing or visual impairment
- Mother without a medical contraindication to breastfeeding
- Parents with access to the internet
Show all 9Show fewer
- Parents willing to participate voluntarily
- Parents living together
- Parents able to receive postpartum education
Who cannot join
- Separation of the mother and infant due to admission to intensive care
- Maternal use of medications contraindicating breastfeeding
- Loss of internet access during the study period
- Discontinuation of breastfeeding due to maternal or infant medical conditions
- Inability to complete follow-up (e.g., relocation, death, or loss to follow-up)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University Training and Research Hospital
Niğde, Merkez, 51000
About this study
Official title: Effects of Breastfeeding Education Based on Health Literacy Improvement Strategy on Breastfeeding Self-Efficacy, Paternal Support, and Breastfeeding Outcomes: A Randomized Controlled Trial
This study aims to evaluate the effects of a comprehensive breastfeeding education program based on a health literacy development strategy on maternal and paternal breastfeeding self-efficacy, fathers' breastfeeding support, parental health literacy, and breastfeeding outcomes. The sustainability of breastfeeding depends not only on maternal knowledge and skills but also on social support mechanisms and parents' ability to access, understand, evaluate, and use health-related information. Fathers play a crucial role in supporting breastfeeding, yet studies incorporating both fathers and health literacy-based educational strategies remain limited. Therefore, this randomized controlled trial was designed to determine whether a structured breastfeeding education program delivered to both mothers and fathers, in addition to routine postpartum care, improves maternal and paternal breastfeeding self-efficacy, fathers' breastfeeding support, parental health literacy, and breastfeeding outcomes.
This study sought to answer the following questions:
- Does breastfeeding education based on a health literacy development strategy affect parents' breastfeeding self-efficacy?
- Does breastfeeding education based on a health literacy development strategy affect fathers' breastfeeding support?
- Does breastfeeding education based on a health literacy development strategy affect breastfeeding outcomes? If so, what is the nature of this effect?
- Does breastfeeding education based on a health literacy development strategy affect the health literacy levels of mothers and fathers?
Read the detailed description
Based on this background, the present randomized controlled trial was designed to evaluate the effects of a structured, health literacy-oriented breastfeeding education program delivered to both mothers and fathers in addition to routine postpartum care. The study aimed to determine whether this comprehensive intervention improved maternal and paternal breastfeeding self-efficacy, increased fathers' breastfeeding support, enhanced parental health literacy, and positively influenced breastfeeding outcomes, including exclusive breastfeeding, bottle or teat use, breastfeeding frequency, breastfeeding duration, formula use, the frequency of breastfeeding problems, and breastfeeding success.
- Conditions
- Breastfeeding
- Being tested
- Routine postpartum breastfeeding care, Experimental
- Keywords
- Breastfeeding, Breastfeeding education, Health literacy, Breastfeeding self-efficacy, Postpartum education, paternal support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine postpartum breastfeeding careOther
Breastfeeding is initiated by nurses or midwives in the hospital within the first hour after birth at most. General information about breastfeeding and breastfeeding is given to the patient for approximately 10 minutes. Afterwards, care is provided in the form of answering the patient's questions, if any.
ExperimentalOther
In this study, a breastfeeding education program was prepared based on the "Integrated Health Literacy Model" that combines the processes of accessing, understanding, appraising, and applying health information. The intervention consisted of a 25-30 minute face-to-face education given by the researcher in the hospital within the first 24 hours after birth. At the end of the training, written material was presented and directions were provided to reliable online resources. In order to support the intervention, telephone counseling was provided in the first week after birth and the La Leche League Turkey article "Breastfeeding Myths" was shared via WhatsApp. On the 15th day, a telephone call was made again to evaluate current experiences and send short support messages. In the first month, information was provided about the TEMAS Association's article "Breastfeeding Volunteer, Mothers Have Something to Say" and the "Tuesday Swings" support activities.
| Study group | Role | What they receive |
|---|---|---|
| Health literacy-based breastfeeding education | Experimental | Participants received a structured breastfeeding education program based on a health literacy development strategy in addition to routine postpartum care. Receives: Other: Experimental |
| Routine Care | Active comparator | Participants received routine postpartum breastfeeding care provided by the hospital. Receives: Other: Routine postpartum breastfeeding care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy level
Health literacy will be assessed using the Turkish version of the 12-item Short-Form Health Literacy Instrument (HLS-SF12). Scores are converted to an index ranging from 0 to 50, with higher scores indicating better health literacy.
Measured: Baseline and postpartum 6-8 weeks
Fathers' breastfeeding support level
Fathers' breastfeeding support will be assessed using the Breastfeeding Support Scale for Fathers. The scale consists of 21 items rated on a 5-point Likert scale. Higher scores indicate greater breastfeeding support.
Measured: Baseline and postpartum 6-8 weeks
Maternal breastfeeding self-efficacy
Maternal breastfeeding self-efficacy will be assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
Measured: Baseline and postpartum 6-8 weeks
Fathers' breastfeeding self-efficacy
Fathers' breastfeeding self-efficacy will be assessed using the Fathers' Breastfeeding Self-Efficacy Scale. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
Measured: Baseline and postpartum 6-8 weeks
Breastfeeding success
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool. Total scores range from 0 to 10, with higher scores indicating greater breastfeeding success.
Measured: Baseline and postpartum 6-8 weeks
Secondary outcomes (1)
Breastfeeding outcomes
Breastfeeding outcomes will be assessed using a researcher-developed questionnaire including infant feeding practices, bottle or pacifier use, breastfeeding-related problems, and infant characteristics.
Measured: Baseline and postpartum 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start13 Oct 2025
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either a health literacy-based breastfeeding education group or a routine postpartum care group. The two groups were followed in parallel from baseline until the postpartum 6-8-week assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aslı suakan sertdemir, Nigde Omer Halisdemir University
- Investigators
- Ozlem ASCI, PhD, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724509
- Sponsor's protocol ID
- 2025/03-08
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breastfeeding Education Based on Health Literacy Improvement Strategy on Breastfeeding Self-Efficacy, Paternal Support, and Breastfeeding Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07724509
- Acronym / sponsor ID
- 2025/03-08
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Breastfeeding education, Health literacy, Breastfeeding self-efficacy, Postpartum education, paternal support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 24 Jul 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 aims to evaluate the effects of a comprehensive breastfeeding education program based on a health literacy development strategy on maternal and paternal breastfeeding self-efficacy, fathers' breastfeeding support, parental health literacy, and breastfeeding outcomes. The sustainability of breastfeeding depends not only on maternal knowledge and skills but also on social support mechanisms and parents' ability to access, understand, evaluate, and use health-related information. Fathers play a crucial role in supporting breastfeeding, yet studies incorporating both fathers and health literacy-based educational strategies remain limited. Therefore, this randomized controlled trial was designed to determine whether a structured breastfeeding education program delivered to both mothers and fathers, in addition to routine postpartum care, improves maternal and paternal breastfeeding self-efficacy, fathers' breastfeeding support, parental health literacy, and breastfeeding outcomes.
This study sought to answer the following questions:
- Does breastfeeding education based on a health literacy development strategy affect parents' breastfeeding self-efficacy?
- Does breastfeeding education based on a health literacy development strategy affect fathers' breastfeeding support?
- Does breastfeeding education based on a health literacy development strategy affect breastfeeding outcomes? If so, what is the nature of this effect?
- Does breastfeeding education based on a health literacy development strategy affect the health literacy levels of mothers and fathers?
Detailed description
Based on this background, the present randomized controlled trial was designed to evaluate the effects of a structured, health literacy-oriented breastfeeding education program delivered to both mothers and fathers in addition to routine postpartum care. The study aimed to determine whether this comprehensive intervention improved maternal and paternal breastfeeding self-efficacy, increased fathers' breastfeeding support, enhanced parental health literacy, and positively influenced breastfeeding outcomes, including exclusive breastfeeding, bottle or teat use, breastfeeding frequency, breastfeeding duration, formula use, the frequency of breastfeeding problems, and breastfeeding success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either a health literacy-based breastfeeding education group or a routine postpartum care group. The two groups were followed in parallel from baseline until the postpartum 6-8-week assessment.
| Arm | Type | Receives |
|---|---|---|
| Health literacy-based breastfeeding education | Experimental | Other: ExperimentalParticipants received a structured breastfeeding education program based on a health literacy development strategy in addition to routine postpartum care. |
| Routine Care | Active comparator | Other: Routine postpartum breastfeeding careParticipants received routine postpartum breastfeeding care provided by the hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Mothers and fathers aged 18-65 years
- Parents of a healthy term infant
- Parents able to read and speak Turkish
- Mothers and fathers without hearing or visual impairment
- Mother without a medical contraindication to breastfeeding
Key exclusion criteria (5 listed)
- Separation of the mother and infant due to admission to intensive care
- Maternal use of medications contraindicating breastfeeding
- Loss of internet access during the study period
- Discontinuation of breastfeeding due to maternal or infant medical conditions
- Inability to complete follow-up (e.g., relocation, death, or loss to follow-up)
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 |
|---|---|---|
| Routine postpartum breastfeeding careBreastfeeding is initiated by nurses or midwives in the hospital within the first hour after birth at most. General information about breastfeeding and breastfeeding is given to the patient for approximately 10 minutes. Afterwards, care is provided in the form of answering the patient's questions, if any. | Other | Routine Care |
| ExperimentalIn this study, a breastfeeding education program was prepared based on the "Integrated Health Literacy Model" that combines the processes of accessing, understanding, appraising, and applying health information. The intervention consisted of a 25-30 minute face-to-face education given by the researcher in the hospital within the first 24 hours after birth. At the end of the training, written material was presented and directions were provided to reliable online resources. In order to support the intervention, telephone counseling was provided in the first week after birth and the La Leche League Turkey article "Breastfeeding Myths" was shared via WhatsApp. On the 15th day, a telephone call was made again to evaluate current experiences and send short support messages. In the first month, information was provided about the TEMAS Association's article "Breastfeeding Volunteer, Mothers Have Something to Say" and the "Tuesday Swings" support activities. | Other | Health literacy-based breastfeeding education |
Primary outcome
Health literacy level
Time frame: Baseline and postpartum 6-8 weeks
Health literacy will be assessed using the Turkish version of the 12-item Short-Form Health Literacy Instrument (HLS-SF12). Scores are converted to an index ranging from 0 to 50, with higher scores indicating better health literacy.
Fathers' breastfeeding support level
Time frame: Baseline and postpartum 6-8 weeks
Fathers' breastfeeding support will be assessed using the Breastfeeding Support Scale for Fathers. The scale consists of 21 items rated on a 5-point Likert scale. Higher scores indicate greater breastfeeding support.
Maternal breastfeeding self-efficacy
Time frame: Baseline and postpartum 6-8 weeks
Maternal breastfeeding self-efficacy will be assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
Fathers' breastfeeding self-efficacy
Time frame: Baseline and postpartum 6-8 weeks
Fathers' breastfeeding self-efficacy will be assessed using the Fathers' Breastfeeding Self-Efficacy Scale. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
Breastfeeding success
Time frame: Baseline and postpartum 6-8 weeks
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool. Total scores range from 0 to 10, with higher scores indicating greater breastfeeding success.
1 secondary outcome
Breastfeeding outcomes
Time frame: Baseline and postpartum 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Ogbo, F. A et al. (2020). Prevalence and determinants of cessation of exclusive breastfeeding in the early postnatal period in Sydney, Australia. Int Breastfeed J. 2017 Apr 8;12:16Link provided by the sponsor.
- Hunter T, Cattelona G. Breastfeeding initiation and duration in first-time mothers: exploring the impact of father involvement in the early post-partum period. Health Promot Perspect. 2014 Dec 30;4(2):132-6Link provided by the sponsor.
- Dennis, C. L. (2003). The breastfeeding self-efficacy scale: Psychometric assessment of the short form. Journal of Obstetric, Gynecologic, \& Neonatal Nursing, 32(6), 734-744.Link provided by the sponsor.
- Victora, C. G., Bahl, R., Barros, A. J. D., França, G. V. A., Horton, S., Krasevec, J., … \& Rollins, N. C. (2016). Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet, 387(10017), 475-490Link provided by the sponsor.
- WHO (20 December 2023), Infant and young child feeding, Key FactsLink provided by the sponsor.
- Cheng GZ, Chen A, Xin Y, Ni QQ. Using the teach-back method to improve postpartum maternal-infant health among women with limited maternal health literacy: a randomized controlled study. BMC Pregnancy Childbirth. 2023 Jan 9;23(1):13Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ozlem ASCI, PhD principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine postpartum breastfeeding care and Experimental in people with Breastfeeding, run by Nigde Omer Halisdemir University 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health literacy level (time frame: Baseline and postpartum 6-8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.