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

NCT06769009 | Recruiting DMC

• 1 other identifier: 101095643
• Study Type: interventional
• Target: 1,000
• Locations: 5 countries
• Sites: 6

Brief Summary

In EUthyroid2 intervention measures are to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of iodine deficiency among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan. A cluster-randomized controlled trial with three points of measurements will be applied in each participating country. The intervention will be adapted to the different contextual characteristics of the implementation sites. A process evaluation with a convergent parallel mixed methods design will be conducted. For this, participants and healthcare professionals will be surveyed and semi-structured interviews will be carried out.

Conditions

Iodine Deficiency

Keywords

prevention; iodine deficiency; intervention study; cluster-randomized controlled trial; complex intervention; adaption to context; awareness; urinary iodine status; iodine intake; nutrition; education

Outcome Measures

Primary Outcomes (1)

• Significant change in awareness of iodine in women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) and compared to women (18-24 years) in the control group.

  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. The difference in iodine awareness in women (18-24 years) is examined: 1. within the intervention group from: * T1 (baseline) compared to T2 (2-4 weeks after the intervention) * T1 (baseline) compared to T3 (6-8 months after the intervention) 2. in the intervention compared to the control group at: * T2 (2-4 weeks after the intervention) * T3 (6-8 months after the intervention)

  T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)

Secondary Outcomes (4)

• Significant change in the urinary iodine status of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group

  T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)

• Significant change in intake of dietary iodine sources of women (18-24 years) within the intervention group from T1 (baseline) to T2 (2-4 weeks) or T3 (6-8 months) and compared to women (18-24 years) in the control group

  T1 = baseline (before the intervention); T2 = first follow-up (2-4 weeks after the intervention); T3 = second follow-up (6-8 months after the intervention)

• Significant change in awareness of iodine of healthcare professionals before (T1) and after the training (T2)

  T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)

• Significant change in intake of dietary iodine sources of the healthcare professional before (T1) and after the training (T2)

  T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Educational intervention measures on iodine, iodine deficiency and iodine intake

Control group

NO INTERVENTION

Interventions

Educational intervention measures on iodine, iodine deficiency and iodine intake BEHAVIORAL

The intervention consist of an educational intervention which will educate the young women on the importance of iodine, the consequences of iodine deficiency, dietary iodine sources and the iodine in pregnancy. The educational intervention consist of four intervention components: an iodine feedback tool, and educational iodine conversation with a healthcare professional, an iodine factsheet and an iodine video. The healthcare professionals who carry out the educational conversation will receive a specially designed training program.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-pregnant Female
• Age 18-24 years at the time point of recruitment
• Attending the specified settings
• Sufficient language skills to understand the study information, informed consent and the questionnaire

You may not qualify if:

• Having a thyroid disease
• Pregnancy at the timepoint of recruitment and during the intervention period
• Lactation

Sponsors & Collaborators

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

Study Sites (6)

Bangladesh University of Health

Dhaka, 1216, Bangladesh

NOT YET RECRUITING

Institute of Marine Research

Bergen, Bergen, 5817, Norway

RECRUITING

Islamia College Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

NOT YET RECRUITING

Jagiellonian University

Krakow, 31-007, Poland

NOT YET RECRUITING

The Queen's University of Belfast

Belfast, BT7 1NN, United Kingdom

NOT YET RECRUITING

University of Surrey

Guildford, GU2 7XH, United Kingdom

NOT YET RECRUITING

Central Study Contacts

Henry Völzke

CONTACT

0049 3834 86 75 41; euthyroid2@uni-greifswald.de

Study Design

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

Model Details: Cluster-randomized controlled trial

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 10, 2025
• Study Start: November 18, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

NO (1); PA (1); BA (1); PL (1); GB (2)