Theory-Based School Program to Improve Health Literacy Among Primary School Children (HEALTH-KIDS)

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

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.

Study Overview

• Status: Completed
• Conditions: Health Literacy
• Intervention / Treatment: Behavioral: Theory-Based School Health Literacy Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Burdur, Turkey, Turkey (Türkiye), 15030
      • Public Primary School, Burdur, Türkiye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Theory-Based Health Literacy Program; 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.	Behavioral: Theory-Based School Health Literacy Program; A six-week classroom-based educational intervention designed to improve health literacy among children aged 9-10 years. The program was developed based on Nutbeam's Health Literacy Model and Piaget's Theory of Cognitive Development and consisted of six weekly 40-minute sessions using educational games, storytelling, role-playing, problem-solving activities, classroom discussions, visual materials, and real-life scenarios to strengthen functional, interactive, and critical health literacy.; Other Names: Primary School Health Literacy Program (PS-HLP)
No Intervention: Standard School Curriculum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	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.	Baseline and one week after completion of the 6-week intervention

Collaborators and Investigators

• Sponsor: Burdur Mehmet Akif Ersoy University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2026
• Primary Completion (Actual): May 30, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Children; Health education; Health literacy; Nutbeam model; Piaget theory
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Health Education
• Other Study ID Numbers: MAKU-HL-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and/or analyzed during the current study are not publicly available because they contain potentially identifiable information from child participants but are available from the corresponding author upon reasonable request and with permission from the relevant ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No