Clinical trial NCT06801691: The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
Official title: The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iodine Deficiency
Keywords: Prevention
Iodine Deficiency
Intervention Study
Complex Intervention
Adaptation to context
Awareness
Iodine intake
Nutrition education
Lead sponsor: EUthyroid
Sponsor class: OTHER
Collaborators: name: EU Horizon
name: UK Research and Innovation
First posted: 2025-01-30
Enrollment: 4500
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in awareness
timeFrame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)
Secondary outcomes:
measure: Changes between teaching modalities
timeFrame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
measure: Changes in vocational schools, high- and secondary schools
timeFrame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
measure: Change between age groups and gender distinctions
timeFrame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
measure: Change in iodine intake
timeFrame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangladesh University of Health
city: Limassol
country: Cyprus
facility: Cyprus University of Technology
city: Greifswald
country: Germany
facility: University Medicine Greifswald
city: Peshawar
country: Pakistan
facility: Islamia College Peshawar
state: Khyber Pakhtunkhwa
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Guildford
country: United Kingdom
facility: University of Surrey; Queen's University Belfast
Study officials:
References: