跳至主要内容
临床试验/NCT06801691
NCT06801691招募中不适用

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

EUthyroid6 个研究点 分布在 6 个国家目标入组 4,500 人开始时间: 2024年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,500
试验地点
6
主要终点
Change in awareness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Teaching programme on iodine

Experimental

Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage

干预措施: Experimental: Intervention group (Other)

结局指标

主要结局

Change in awareness

时间窗: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)

1. Change in awareness of iodine and iodine deficiency: Difference in iodine awareness is measured by an iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.

次要结局

  • Changes between teaching modalities(T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months))
  • Changes in vocational schools, high- and secondary schools(T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months))
  • Change between age groups and gender distinctions(T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months))
  • Change in iodine intake(T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months))

研究者

发起方
EUthyroid
申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验