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Completed

NCT Number: NCT07724509

Effectiveness of a Health Literacy-Based Breastfeeding Education Program

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nigde Omer Halisdemir University Training and Research Hospital

Niğde, Merkez, 51000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Breastfeeding outcomes

    Time frame: Baseline and postpartum 6-8 weeks

    Breastfeeding outcomes will be assessed using a researcher-developed questionnaire including infant feeding practices, bottle or pacifier use, breastfeeding-related problems, and infant characteristics.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Effects of Breastfeeding Education Based on Health Literacy Improvement Strategy on Breastfeeding Self-Efficacy, Paternal Support, and Breastfeeding Outcomes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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