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

9. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

128

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • Primary School Health Literacy Program (PS-HLP)
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health literacy
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Burdur Mehmet Akif Ersoy University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. april 2026

Primær fullføring (Faktiske)

30. mai 2026

Studiet fullført (Faktiske)

30. mai 2026

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MAKU-HL-2026-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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