- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07601815
MEST : A School- Based Health Literacy Intervention Trial
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
Condiciones
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hanne N Bjørnsen, RN, MS, MPH, PhD
- Número de teléfono: 004790107526
- Correo electrónico: hanne.nissen.bjornsen@fhi.no
Copia de seguridad de contactos de estudio
- Nombre: Hilde E Toreid, RN, MS
- Número de teléfono: 004790874102
- Correo electrónico: hilde.elisabeth.toreid@fhi.no
Ubicaciones de estudio
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Trøndelag
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Levanger, Trøndelag, Noruega, 7600
- Norwegian Institute of Public Health (NIPH)
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Contacto:
- Hilde E Toreid, RN, MS
- Número de teléfono: 004790874102
- Correo electrónico: hilde.elisabeth.toreid@fhi.no
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Contacto:
- Boye Welde, Dr.Philos
- Número de teléfono: 004799357696
- Correo electrónico: boye.welde@fhi.no
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Investigador principal:
- Hilde E Toreid, RN, MS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
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
¿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 |
|---|---|
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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General Health Literacy
Periodo de tiempo: Baseline, 4 months, 9 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental Health Literacy
Periodo de tiempo: Baseline, 4 months, 9 months
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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.
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Baseline, 4 months, 9 months
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Mental Well-Being
Periodo de tiempo: Baseline, 4 months, 9 months
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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.
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Baseline, 4 months, 9 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hanne N Bjørnsen, RN, MS, MPH, PhD, Norwegian Institute of Public Health
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
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)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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