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临床试验/NCT07724509
NCT07724509已完成不适用

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

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Health literacy level

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Participants and care providers were not masked due to the nature of the educational intervention. The outcome assessor was blinded to participant group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Health literacy level

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Breastfeeding outcomes(Baseline and postpartum 6-8 weeks)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

aslı suakan sertdemir

MSc RNurse Aslı SUAKAN SERTDEMİR

Nigde Omer Halisdemir University

研究点 (1)

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