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Идёт набор NCT06801691

The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe

Без фазы С лечением Iodine Deficiency

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: Experimental: Intervention group.
Кому может быть актуально
Состояния в реестре: Iodine Deficiency. Базовые параметры: 13 лет — 17 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
Bangladesh, Cyprus, Германия, Пакистан, Словения +1
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In the EUthyroid2 intervention, measures are being developed and implemented in educational settings across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan to effectively raise awareness of the risks associated with iodine deficiency. Each participating country will employ three measurement points. The intervention will be tailored to the specific contextual characteristics of each implementation site. A process evaluation utilizing a convergent parallel mixed methods design will be conducted, involving surveys of students and teachers, as well as semi-structured interviews.

Подробное описание

Detailed Description:

BACKGROUND: Iodine deficiency (ID) is a leading risk factor for thyroid disorders and developmental impairments in offspring. It is recognized as one of the most preventable causes of mental impairment in children. The EUthyroid2 project aims to contribute to the prevention of ID and its associated symptoms and disease burden in adolescents across Europe and beyond.

AIM: This project seeks to develop and implement an educational intervention in various educational settings, effectively raising awareness of the risks associated with iodine deficiency.

METHODS: The intervention will be conducted in each participating country, with three clusters (secondary schools, high schools, and vocational schools) per country. The goal is to achieve a final sample of 4500 study participants in all countries combined, involving one baseline measurement and two follow-up assessments (2-4 weeks and 6-8 months post-intervention). Data will be collected at all measurement points, with variations in implementation accounted for due to differences between countries. To ensure the intervention's functionality and effectiveness, the project will consider recommendations for developing complex interventions, appropriate theoretical frameworks, and conduct a context analysis. Outcome measures will include a newly developed iodine awareness questionnaire (primary outcome) and an iodine-specific food frequency questionnaire. Additionally, socio-demographic characteristics will be measured. Descriptive analyses will be performed on all variables, with subgroup and country-specific analyses computed. A process evaluation will assess the implementation process using a convergent parallel mixed methods design, inviting teachers and students to participate in an online questionnaire. Semi-structured interviews will further enrich this evaluation.

CONCLUSION/OUTLOOK: The results of the EUthyroid2 project may assist health authorities across participating countries in implementing effective strategies to reduce iodine deficiency and its associated risks. Ultimately, this could lead to a sustainable decrease in the disease burden induced by iodine deficiency.

Вмешательства

  • Другое Experimental: Intervention group
    Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage This is a pre/post intervention with no control group.

Первичные конечные точки

  • Change in awareness [Срок оценки: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)]
Вторичные конечные точки (4)
  • Changes between teaching modalities [Срок оценки: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
  • Changes in vocational schools, high- and secondary schools [Срок оценки: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
  • Change between age groups and gender distinctions [Срок оценки: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
  • Change in iodine intake [Срок оценки: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]

Критерии участия

Критерии включения

  • sufficient language skills to understand the study information, informed consent

Критерии исключения

  • none

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Bangladesh · 1 центр
  • Bangladesh University of Health — Dhaka
Cyprus · 1 центр
  • Cyprus University of Technology — Limassol
Германия · 1 центр
  • University Medicine Greifswald — Greifswald
Пакистан · 1 центр
  • Islamia College Peshawar — Peshawar
Словения · 1 центр
  • University Medical Centre Ljubljana — Ljubljana
Великобритания · 1 центр
  • University of Surrey; Queen's University Belfast — Guildford

Идентификаторы

NCT: NCT06801691 · 101095643_2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗