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临床试验/NCT07702591
NCT07702591已完成不适用

Effectiveness of a Theory-Based School Program to Improve Health Literacy Among Children Aged 9-10 Years: A Cluster Randomized Controlled Trial

Burdur Mehmet Akif Ersoy University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Health literacy

研究概览

简要总结

Health literacy is a key determinant of children's health and well-being, enabling them to access, understand, evaluate, and use health information to make informed health-related decisions. Middle childhood represents a critical developmental period for strengthening these competencies; however, evidence regarding theory-based school interventions designed to improve health literacy in this age group remains limited.

This cluster randomized controlled trial aims to evaluate the effectiveness of a six-week, theory-based school health literacy program developed for children aged 9-10 years. The intervention was designed by integrating Nutbeam's Health Literacy Model and Piaget's Theory of Cognitive Development and incorporates interactive, child-centered educational strategies, including educational games, storytelling, role-playing, problem-solving activities, and classroom discussions. Third- and fourth-grade students attending public primary schools in Burdur, Türkiye, were randomly assigned at the school level to either the intervention or control group. Health literacy outcomes are assessed using the Health Literacy Survey Questionnaire for Children-Turkish Version (HLS-Child-Q15-TR) before and after the intervention. The findings are expected to provide evidence regarding the effectiveness of theory-based school health literacy interventions and to inform future school health promotion programs.

详细描述

Health literacy is recognized as a fundamental determinant of lifelong health and well-being. Childhood represents a critical period for the development of health literacy competencies because children begin to acquire the cognitive, social, and behavioral skills necessary to access, understand, evaluate, and apply health information in everyday life. Despite growing international interest in promoting health literacy among children, evidence regarding theoretically informed school-based interventions remains limited.

This study evaluates a theory-based school health literacy intervention developed for primary school children aged 9-10 years. The intervention was designed by integrating Nutbeam's Health Literacy Model, which conceptualizes health literacy as functional, interactive, and critical competencies, with Piaget's Theory of Cognitive Development, emphasizing learning strategies appropriate for children in the concrete operational stage. The program incorporates child-centered educational approaches, including educational games, storytelling, role-playing, problem-solving activities, visual materials, classroom discussions, and real-life scenarios to facilitate active learning and the application of health information.

The intervention consists of six weekly classroom sessions delivered over a six-week period. The effectiveness of the program is evaluated using a cluster randomized controlled trial conducted in public primary schools in Burdur, Türkiye. Health literacy is assessed before and after the intervention using the Health Literacy Survey Questionnaire for Children-Turkish Version (HLS-Child-Q15-TR). The findings are expected to contribute to the evidence base for theory-based school health literacy interventions and support the development of effective school health promotion programs for children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Blinding was not feasible because the educational intervention was delivered directly to students in the classroom by the principal investigator. Consequently, participants, investigators, and outcome assessors were aware of group allocation.

入排标准

年龄范围
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 9-10 years.
  • Enrolled in the third or fourth grade of a participating public primary school.
  • Able to understand and complete the study questionnaires.
  • Written informed consent obtained from a parent or legal guardian.
  • Child provided verbal assent to participate.

排除标准

  • Participation in a structured health literacy education program with similar content within the previous 6 months.
  • Inability to participate in the intervention sessions because of prolonged absence from school.
  • Attendance at <80% of the intervention sessions.
  • Withdrawal of parental consent or child assent at any time during the study.

研究组 & 干预措施

Theory-Based Health Literacy Program

Experimental

Participants received a six-week theory-based school health literacy intervention delivered in the classroom once weekly (40 minutes per session). The program was developed based on Nutbeam's Health Literacy Model and Piaget's Theory of Cognitive Development and incorporated interactive educational strategies, including educational games, storytelling, role-playing, group discussions, problem-solving activities, visual materials, and real-life scenarios to improve children's health literacy.

干预措施: Theory-Based School Health Literacy Program (Behavioral)

Standard School Curriculum

No Intervention

Participants continued to receive the standard school curriculum without any additional health literacy intervention during the study period. Following completion of the post-intervention assessments, students in the control group were offered the same health literacy program in accordance with ethical principles.

结局指标

主要结局

Health literacy

时间窗: Baseline and one week after completion of the 6-week intervention

Children's health literacy will be assessed using the Turkish version of the Health Literacy Survey Questionnaire for Children (HLS-Child-Q15-TR). The scale consists of 15 items across three domains: health care, disease prevention, and health promotion. Items are rated on a 4-point Likert scale from 1 to 4, with higher scores indicating greater difficulty in dealing with health-related information. Scores may be transformed so that higher transformed scores indicate higher health literacy, depending on the scoring procedure used.

次要结局

未报告次要终点

研究者

发起方
Burdur Mehmet Akif Ersoy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Sezer Balci

Assistant Professor, PhD, RN - Department of Public Health Nursing, Burdur Mehmet Akif Ersoy University

Burdur Mehmet Akif Ersoy University

研究点 (1)

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