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Набор скоро начнётся NCT07601815

MEST : A School- Based Health Literacy Intervention Trial

Без фазы С лечением Health Literacy Adolescent Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MEST Work Strategy.
Кому может быть актуально
Состояния в реестре: Health Literacy, Adolescent Health. Базовые параметры: 16 лет — 24 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое MEST Work Strategy
    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 sc

Первичные конечные точки

  • General Health Literacy [Срок оценки: Baseline, 4 months, 9 months]
Вторичные конечные точки (2)
  • Mental Health Literacy [Срок оценки: Baseline, 4 months, 9 months]
  • Mental Well-Being [Срок оценки: Baseline, 4 months, 9 months]

Критерии участия

Критерии включения

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

Критерии исключения

\- Students <16 years and > 24 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Норвегия · 1 центр
  • Norwegian Institute of Public Health (NIPH) — Levanger

Публикации

  • Bjornsen HN, Ringdal R, Espnes GA, Eilertsen MB, Moksnes UK. Exploring MEST: a new universal teaching strategy for school health services to promote positive mental health literacy and mental wellbeing among Norwegian adolescents. BMC Health Serv Res. 2018 Dec 29;18(1):1001. doi: 10.1186/s12913-018-3829-8. PMID 30594201

Идентификаторы

NCT: NCT07601815 · SDAM_FOR555624 /NIPH 6107-6107

Первоисточники (государственные реестры)

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