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

NCT06801691 | Recruiting DMC

• 1 other identifier: 101095643_2
• Study Type: interventional
• Target: 4,500
• Locations: 6 countries
• Sites: 6

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.

Conditions

Iodine Deficiency

Keywords

Prevention; Iodine Deficiency; Intervention Study; Complex Intervention; Adaptation to context; Awareness; Iodine intake; Nutrition education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes between teaching modalities

  T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

• Changes in vocational schools, high- and secondary schools

  T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

• Change between age groups and gender distinctions

  T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

• Change in iodine intake

  T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

Study Arms (1)

Teaching programme on iodine

EXPERIMENTAL

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

Other: Experimental: Intervention group

Interventions

Experimental: Intervention group 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.

Teaching programme on iodine

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• EUthyroid: lead
• EU Horizon: collaborator
• UK Research and Innovation: collaborator

Study Sites (6)

Bangladesh University of Health

Dhaka, 1216, Bangladesh

RECRUITING

Cyprus University of Technology

Limassol, 3041, Cyprus

RECRUITING

University Medicine Greifswald

Greifswald, 17475, Germany

RECRUITING

Islamia College Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

University of Surrey; Queen's University Belfast

Guildford, GU2 7XH, United Kingdom

RECRUITING

Central Study Contacts

Henry Völzke

CONTACT

0049 3834 86 75 41; henry.voelzke@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 30, 2025
• Study Start: December 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-01

Locations

CY (1); SL (1); GB (1); PA (1); BA (1); DE (1)