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

Last updated: February 27, 2025
Sponsor: EUthyroid
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Experimental: Intervention group

Clinical Study ID

NCT06801691
101095643_2
  • Ages 13-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 4500
Treatment Group(s): 1
Primary Treatment: Experimental: Intervention group
Phase:
Study Start date:
December 30, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Bangladesh University of Health

    Dhaka, 1216
    Bangladesh

    Active - Recruiting

  • Cyprus University of Technology

    Limassol, 3041
    Cyprus

    Active - Recruiting

  • University Medicine Greifswald

    Greifswald, 17475
    Germany

    Active - Recruiting

  • Islamia College Peshawar

    Peshawar, Khyber Pakhtunkhwa
    Pakistan

    Active - Recruiting

  • University Medical Centre Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • University of Surrey; Queen's University Belfast

    Guildford, GU2 7XH
    United Kingdom

    Active - Recruiting

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