- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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).
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hanne N Bjørnsen, RN, MS, MPH, PhD
- Номер телефона: 004790107526
- Электронная почта: hanne.nissen.bjornsen@fhi.no
Учебное резервное копирование контактов
- Имя: Hilde E Toreid, RN, MS
- Номер телефона: 004790874102
- Электронная почта: hilde.elisabeth.toreid@fhi.no
Места учебы
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Trøndelag
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Levanger, Trøndelag, Норвегия, 7600
- Norwegian Institute of Public Health (NIPH)
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Контакт:
- Hilde E Toreid, RN, MS
- Номер телефона: 004790874102
- Электронная почта: hilde.elisabeth.toreid@fhi.no
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Контакт:
- Boye Welde, Dr.Philos
- Номер телефона: 004799357696
- Электронная почта: boye.welde@fhi.no
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Главный следователь:
- Hilde E Toreid, RN, MS
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Students 16-24 years
- Students enrolled in upper secondary school classes
- Provided informed consent
Exclusion Criteria:
- Students <16 years and > 24 years
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Без вмешательства: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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General Health Literacy
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mental Health Literacy
Временное ограничение: 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.
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Baseline, 4 months, 9 months
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Mental Well-Being
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Главный следователь: Hanne N Bjørnsen, RN, MS, MPH, PhD, Norwegian Institute of Public Health
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- SDAM_FOR555624 /NIPH 6107-6107
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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