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MEST : A School- Based Health Literacy Intervention Trial

18 de mayo de 2026 actualizado por: Norwegian Institute of Public Health

A Cluster- Randomized Controlled Trial Evaluating the MEST Work Strategy to Improve Health Literacy Among Upper Secondary School Students

The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. The study assesses whether implementation of the MEST work strategy results in improved health literacy and mental well being compared with usual school health services.

This study is a cluster randomized superiority trial in which upper secondary schools are assigned either to an intervention group implementing the MEST work strategy or to a control group continuing with school health services as usual. Student reported outcomes are collected using digitally administered questionnaires during school hours at baseline, prior to initiation of the intervention, and at 4 and 9 months following intervention initiation (end of the school year).

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

This study is a cluster randomized controlled trial conducted in upper secondary schools, with schools serving as the unit of randomization to minimize contamination between students. A matched pair allocation design is used to ensure balance between trial arms. The anticipated enrollment is 12 schools (clusters).

Simulation based power analyses indicated that the primary analytic models yielded approximately 0.62-0.72 power to detect an effect size of d = 0.30 and were generally close to or exceeded 0.80 when the post test effect size was larger (d = 0.40).

The MEST work strategy is implemented during regular school hours by school health services and is designed to enhance students' ability to access, understand, evaluate, and apply health related information, with a specific focus on health literacy and mental well being. Data are collected using digitally administered questionnaires at baseline (T0), 4 months (T1), and 9 months (T2) following initiation of the intervention.

The primary outcome is general health literacy. Secondary outcomes include mental health literacy and mental well being. Prespecified secondary subgroup/moderator analyses will examine potential effect modification by gender, socioeconomic status, and minority, Indigenous, or immigrant background. Additional exploratory analyses will assess whether the dose of the MEST work strategy delivered is associated with outcomes. Outcome data are reported by students, while information on intervention dose is obtained from the school health services.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1800

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Trøndelag
      • Levanger, Trøndelag, Noruega, 7600
        • Norwegian Institute of Public Health (NIPH)
        • Contacto:
        • Contacto:
          • Boye Welde, Dr.Philos
          • Número de teléfono: 004799357696
          • Correo electrónico: boye.welde@fhi.no
        • Investigador principal:
          • Hilde E Toreid, RN, MS

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Students 16-24 years
  • Students enrolled in upper secondary school classes
  • Provided informed consent

Exclusion Criteria:

- Students <16 years and > 24 years

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MEST Work Strategy
Schools assigned to the intervention arm receive the MEST work strategy delivered by school health services during regular school hours over one school year. The intervention is designed to strengthen students' general health literacy through structured learning activities, facilitated discussions, and individual follow up when needed.
The MEST work strategy is needs based and adaptive. An anonymous, digitally administered MEST survey conducted prior to intervention initiation informs the selection and tailoring of intervention topics throughout the school year. This survey is used solely to guide intervention delivery and is not included in the outcome evaluation. Intervention activities may include classroom based sessions, school wide seminars, small thematic group activities, and individual consultations provided by the school health services, depending on identified student needs. All activities are conducted on school premises using existing school facilities and digital infrastructure.
Sin intervención: Control- School Health Servics as usual
Schools assigned to the control arm continue with school health services as usual throughout the study period. Usual care includes routine health promotion activities and access to individual consultations provided within the existing school health services. Schools in the control arm are not exposed to the MEST work strategy during the study period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
General Health Literacy
Periodo de tiempo: Baseline, 4 months, 9 months

General health literacy assessed using the Health Literacy Survey 2019 - Young Persons 12-item scale (HLS19 YP12).

The instrument consists of 12 items, each rated on a 4 point scale. Total scores range from 12 to 48, with higher scores indicating higher (better) levels of health literacy.

Baseline, 4 months, 9 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mental Health Literacy
Periodo de tiempo: Baseline, 4 months, 9 months
Mental health literacy using the Mental Health Learning Scale (MHLS-9). The instrument consists of 9 items, each rated on a 5- point likert scale, giving a total score from 9 to 45, with higher scores indicating higher (better) levels of mental health literacy.
Baseline, 4 months, 9 months
Mental Well-Being
Periodo de tiempo: Baseline, 4 months, 9 months
Mental well-being assessed using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). The instrument consist of 7 items, each rated on a 5- point scale. It ranges from 7 to 35 points, with higher scores indicating better mental well- being.
Baseline, 4 months, 9 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hanne N Bjørnsen, RN, MS, MPH, PhD, Norwegian Institute of Public Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

17 de agosto de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SDAM_FOR555624 /NIPH 6107-6107

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

We collect sensitive information about health litearcy, mental health litearcy and mental well- being, hence we will not share IPD.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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