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