An interventional study of Experimental: Intervention group in Iodine Deficiency, sponsored by EUthyroid. Recruiting at 6 sites in 6 countries. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by EUthyroid · Not applicable, Interventional, and Prevention
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:
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.
This is the only study on the registry with EUthyroid as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage
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.
Change in awareness
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.
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)
Changes between teaching modalities
Differences in iodine awareness between students taught module A vs module A+B vs module A+C vs module A+B+C. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Changes in vocational schools, high- and secondary schools
Differences in iodine awareness between students in vocational schools vs high schools vs secondary schools. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change between age groups and gender distinctions
Differences in iodine awareness between girls vs boys. Changes in iodine awareness are assessed by the iodine awareness questionnaire. Differences in iodine awareness between 13-year-olds vs 14-year-olds vs 15-year-olds vs 16-year-olds vs 17-year-olds. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness. Gender and age will be self-reported in a socio-demographic questionnaire.
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Change in iodine intake
Dietary iodine intake is assessed through a food frequency questionnaire (FFQ), covering five main categories (cow's milk, fish, eggs, supplements, and salt) and regional components in each country. Each category is scored based on frequency (portions per day, week, or month), and individual sources are analyzed for iodine intake. For example, taking supplements 5-7 times a week or consuming a combination of multiple sources of cow's milk, fish and eggs a week may suggest sufficient intake. Regional differences are also considered, as salt is an iodine source in countries like Pakistan and Bangladesh, but not in the UK or Norway. The number of iodine sources will be compared before and after the intervention within each country, with a higher number of sources indicating a higher iodine intake). The number will differ according to the number of sources in each country.
Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
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