The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Intervention group.
- Who it may be relevant to
- Registry conditions: Iodine Deficiency. Basic parameters: 13 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh, Cyprus, Germany, Pakistan, Slovenia +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Change in awareness [Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)]
Secondary outcome measures (4)
- Changes between teaching modalities [Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
- Changes in vocational schools, high- and secondary schools [Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
- Change between age groups and gender distinctions [Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
- Change in iodine intake [Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)]
Eligibility criteria
Inclusion criteria
- sufficient language skills to understand the study information, informed consent
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Bangladesh · 1 center
- Bangladesh University of Health — Dhaka
Cyprus · 1 center
- Cyprus University of Technology — Limassol
Germany · 1 center
- University Medicine Greifswald — Greifswald
Pakistan · 1 center
- Islamia College Peshawar — Peshawar
Slovenia · 1 center
- University Medical Centre Ljubljana — Ljubljana
United Kingdom · 1 center
- University of Surrey; Queen's University Belfast — Guildford
Identifiers
NCT: NCT06801691 · 101095643_2