Effectiveness of a Health Literacy-Based Breastfeeding Education Program

NCT07724509 | Completed

• 1 other identifier: 2025/03-08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Does breastfeeding education based on a health literacy development strategy affect parents' breastfeeding self-efficacy?
2. 2.Does breastfeeding education based on a health literacy development strategy affect fathers' breastfeeding support?
3. 3.Does breastfeeding education based on a health literacy development strategy affect breastfeeding outcomes? If so, what is the nature of this effect?
4. 4.Does breastfeeding education based on a health literacy development strategy affect the health literacy levels of mothers and fathers?

Conditions

Breastfeeding

Keywords

Breastfeeding; Breastfeeding education; Health literacy; Breastfeeding self-efficacy; Postpartum education; paternal support

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline and postpartum 6-8 weeks

Secondary Outcomes (1)

• Breastfeeding outcomes

  Baseline and postpartum 6-8 weeks

Study Arms (2)

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.

Other: Experimental

Routine Care

ACTIVE COMPARATOR

Participants received routine postpartum breastfeeding care provided by the hospital.

Other: Routine postpartum breastfeeding care

Interventions

Routine postpartum breastfeeding care OTHER

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.

Routine Care

Experimental OTHER

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.

Health literacy-based breastfeeding education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Parents willing to participate voluntarily
• Parents living together
• Parents able to receive postpartum education

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University Training and Research Hospital

Niğde, Merkez, 51000, Turkey (Türkiye)

Location

Related Links

• 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;12:16
• 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):132-6
• 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.
• 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), 475-490
• WHO (20 December 2023), Infant and young child feeding, Key Facts
• 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):13
• Çetindemir EO, Cangöl E. The effect of breastfeeding education given through the teach-back method on mothers' breastfeeding self-efficacy and breastfeeding success: a randomized controlled study. BMC Pregnancy Childbirth. 2024 Jun 29;24(1):453.
• Panahi F, Rashidi Fakari F, Nazarpour S, Lotfi R, Rahimizadeh M, Nasiri M, Simbar M. Educating fathers to improve exclusive breastfeeding practices: a randomized controlled trial. BMC Health Serv Res. 2022 Apr 26;22(1):554.
• Sezer HK, Ceran MA, Demirsoz M, Kucukoglu S. Development and psychometric evaluation of the paternal support scale of breastfeeding. J Pediatr Nurs. 2024 Mar-Apr;75:149-157.
• Ayran, G., \& Çelebioğlu, A. (2022). Education of parents in increasing breastfeeding rates, success, and self-efficacy levels. The Journal of Pediatric Research, 9(2), 175-183.
• Küçükoğlu, S., Sezer, H. K., \& Dennis, C. L. (2023). Validity and reliability of the Turkish version of the paternal breastfeeding self-efficacy scale - Short form for fathers. Midwifery, 116, 103513.
• Karahan Yılmaz, S., \& Eskici, G. (2021). Validity and Reliability Study of The Turkish Form of The Health Literacy Scale-Short Form and Digital Healthy Diet Literacy Scale. İzmir Kâtip Çelebi University Faculty of Health Sciences Journal, 6(3), 19-25.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ozlem ASCI, PhD

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and care providers were not masked due to the nature of the educational intervention. The outcome assessor was blinded to participant group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc RNurse Aslı SUAKAN SERTDEMİR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: July 24, 2026
• Study Start: October 13, 2025
• Primary Completion: May 18, 2026
• Study Completion: May 18, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)