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

NCT ID: NCT06801691

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Iodine Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Teaching programme on iodine

Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage

Group Type EXPERIMENTAL

Experimental: Intervention group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EU Horizon

UNKNOWN

Sponsor Role collaborator

UK Research and Innovation

OTHER

Sponsor Role collaborator

EUthyroid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bangladesh University of Health

Dhaka, , Bangladesh

Site Status RECRUITING

Cyprus University of Technology

Limassol, , Cyprus

Site Status RECRUITING

University Medicine Greifswald

Greifswald, , Germany

Site Status RECRUITING

Islamia College Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

University of Surrey; Queen's University Belfast

Guildford, , United Kingdom

Site Status RECRUITING

Countries

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Bangladesh Cyprus Germany Pakistan Slovenia United Kingdom

Central Contacts

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Henry Völzke

Role: CONTACT

0049 3834 86 75 41

Facility Contacts

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Mithila Faruque, Dr

Role: primary

+880 1791-042087

Konstantinos C. Makris, PhD

Role: primary

+357 25002398

Henry Völzke, Prof. Dr. med.

Role: primary

0049 3834 86 75 41

Rehman Mehmood Khattak, Dr.

Role: primary

+92 91 9222227

Simona Gaberšček, MD

Role: primary

+38 615 223 551

Sarah Bath, PhD, RD, FHEA

Role: primary

+44 1483 300800

Other Identifiers

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101095643_2

Identifier Type: -

Identifier Source: org_study_id

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