Theory-Based School Program to Improve Health Literacy Among Primary School Children

NCT07702591 | Completed

• 1 other identifier: MAKU-HL-2026-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Literacy

Keywords

Health literacy; Nutbeam model; Piaget theory; Children; Health education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Theory-Based School Health Literacy Program

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.

Interventions

Theory-Based School Health Literacy Program BEHAVIORAL

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.

Also known as: Primary School Health Literacy Program (PS-HLP)

Theory-Based Health Literacy Program

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Public Primary School, Burdur, Türkiye

Burdur, Turkey, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD, RN - Department of Public Health Nursing, Burdur Mehmet Akif Ersoy University

Model Details: Public primary schools were randomized at the school (cluster) level to either the intervention or control group. Third- and fourth-grade classrooms were randomly selected within each school. Students in the intervention group received a six-week theory-based school health literacy program, while those in the control group continued with the standard school curriculum during the study period. Outcome assessments were conducted at baseline and immediately after completion of the intervention.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: April 2, 2026
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)