The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe (EUthyroid2)

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.

Study Overview

• Status: Recruiting
• Conditions: Iodine Deficiency
• Intervention / Treatment: Other: Experimental: Intervention group

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.

• Study Type: Interventional
• Enrollment (Estimated): 4500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henry Völzke; Phone Number: 0049 3834 86 75 41; Email: henry.voelzke@med.uni-greifswald.de

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1216
    • Recruiting
    • Bangladesh University of Health
    • Contact: Mithila Faruque, Dr; Phone Number: +880 1791-042087; Email: mithilafaruque@buhs.ac.bd
• Cyprus
  • Limassol, Cyprus, 3041
    • Recruiting
    • Cyprus University of Technology
    • Contact: Konstantinos C. Makris, PhD; Phone Number: +357 25002398; Email: konstantinos.makris@cut.ac.cy
• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • University Medicine Greifswald
    • Contact: Henry Völzke, Prof. Dr. med.; Phone Number: 0049 3834 86 75 41; Email: euthyroid2@uni-greifswald.de
• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Recruiting
      • Islamia College Peshawar
      • Contact: Rehman Mehmood Khattak, Dr.; Phone Number: +92 91 9222227; Email: rehman.mehmood@icp.edu.pk
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: Simona Gaberšček, MD; Phone Number: +38 615 223 551; Email: simona.gaberscek@kclj.si
• United Kingdom
  • Guildford, United Kingdom, GU2 7XH
    • Recruiting
    • University of Surrey; Queen's University Belfast
    • Contact: Sarah Bath, PhD, RD, FHEA; Phone Number: +44 1483 300800; Email: s.bath@surrey.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teaching programme on iodine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

Collaborators and Investigators

• Sponsor: EUthyroid
• Collaborators: UK Research and Innovation; EU Horizon

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Intervention Study; Awareness; Nutrition education; Complex Intervention; Iodine Deficiency; Iodine intake; Adaptation to context
• Other Study ID Numbers: 101095643_2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No