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

9 juillet 2026 mis à jour par: Ayse Sezer Balci, Burdur Mehmet Akif Ersoy University

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

128

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Autres noms:
  • Primary School Health Literacy Program (PS-HLP)
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Health literacy
Délai: 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.
Baseline and one week after completion of the 6-week intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 avril 2026

Achèvement primaire (Réel)

30 mai 2026

Achèvement de l'étude (Réel)

30 mai 2026

Dates d'inscription aux études

Première soumission

8 juillet 2026

Première soumission répondant aux critères de contrôle qualité

9 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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