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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Iodine Deficiency
• Intervention / Treatment: Behavioral: Educational intervention measures on iodine, iodine deficiency and iodine intake

Detailed Description

BACKGROUND: Iodine deficiency (ID) is a leading risk factor for the development of thyroid disorders, of which in particular women are affected. During pregnancy, ID can increase the risk of developmental disorders in the offspring, however, it is considered as one of the most preventable causes of mental impairment in children. Therefore, the EUthyroid2 project aims to contribute to the prevention of ID and associated symptom and disease burden in adolescence and young women in Europe and beyond.

AIM: An educational intervention is to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of ID among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan.

METHODS: A cluster-randomised controlled trial is to be conducted in each of the five countries. 10 clusters per country (5 intervention group clusters and 5 control group clusters) are planned to achieve a final sample size of 200 study participants per implementing country with one baseline (before the intervention) and two follow-up measurements (2-4 weeks and 6-8 months after the intervention). In all, 1000 participants are to be recruited and data for all measurement points collected. Due to differences in the healthcare systems, the ambulatory care units, where the intervention will be implemented, may vary across the countries. Before recruiting the women, the healthcare professionals who carry out the intervention will receive a specially designed training program. To assure the intervention's functionality and effectiveness, recommendations for the development of complex interventions, appropriate theories and frameworks will be considered and a context analysis will be conducted. The primary outcome of the study is iodine awareness and knowledge measured by a newly developed questionnaire. Other outcomes includes measurement of iodine status (urinary iodine concentration), intake of dietary iodine sources (measured by a food frequency questionnaire), and iodine related behaviours. Sociodemographic characteristics and general dietary habits will also be measured. Descriptive analyses for all variables will be performed. Intervention groups will be compared to control groups over time to test effectiveness. Subgroup and country-specific analyses will also be computed. A process evaluation will be conducted to evaluate the implementation process with a convergent parallel mixed methods design. For this, healthcare professionals in the ambulatory care settings and the women who received the intervention will be invited to participate in an online survey. Further, ca. 20-30 semi-structured interviews will be conducted with women and healthcare professionals.

CONCLUSION / OUTLOOK: The project results may support health authorities across countries to implement effective measures to reduce ID and associated risks. This may sustainably reduce the disease burden induced by ID for young women, pregnant women and their offspring.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henry Völzke; Phone Number: 0049 3834 86 75 41; Email: euthyroid2@uni-greifswald.de

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1216
    • Not yet recruiting
    • Bangladesh University of Health
    • Contact: Mithila Faruque, Dr.; Phone Number: +880 1791-042087; Email: mithilafaruque@buhs.ac.bd
• Norway
  • Bergen, Norway, 5817
    • Recruiting
    • Institute of Marine Research
    • Contact: Lisbeth Dahl, Dr.; Phone Number: +47 472 91 689; Email: lisbeth.dahl@hi.no
• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Not yet recruiting
      • Islamia College Peshawar
      • Contact: Rehman Mehmood Khattak, Dr.; Phone Number: +92 91 9222227; Email: rehman.mehmood@icp.edu.pk
• Poland
  • Krakow, Poland, 31-007
    • Not yet recruiting
    • Jagiellonian University
    • Contact: Małgorzata Trofimiuk-Müldner, MD PhD; Phone Number: +48 12 4002300; Email: malgorzata.trofimiuk@uj.edu.pl
• United Kingdom
  • Belfast, United Kingdom, BT7 1NN
    • Not yet recruiting
    • The Queen's University of Belfast
    • Contact: Jayne Woodside, Prof.; Phone Number: +44 28 909 78942; Email: j.woodside@qub.ac.uk
  • Guildford, United Kingdom, GU2 7XH
    • Not yet recruiting
    • University of Surrey
    • Contact: Sarah Bath, PhD, RD, FHEA; Phone Number: +44 1483 300800; Email: s.bath@surrey.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Behavioral: Educational intervention measures on iodine, iodine deficiency and iodine intake; 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.
No Intervention: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The urinary iodine concentration will be measured on a scale from 0- to n (there is no maximum value). The median UIC will be compared against the WHO classification of adequate iodine intake of a median UIC ≥100 µg/L and will be compared within the interention group and at each time-point between the intervention and control group. Difference in iodine status (measured by UIC in µg/L) of women (18-14 years) is examined: within the intervention group before and after the intervention:T1 (baseline) compared to T2 (2-4 weeks after the intervention)T1 (baseline) compared to T3 (6-8 months after the intervention); in the intervention group 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)
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	Differences in intake of dietary iodine sources is measured by a food frequency questionnaire (FFQ).Dietary iodine intake is assessed through a food frequency questionnaire (FFQ), covering five main categories (cow's milk, fish, eggs, supplements, and salt) and regional components in each country. Each category is scored based on frequency (portions per day, week, or month), and individual sources are analyzed for iodine intake. Difference in the FFQ of women (18-24 years) is examined: within the intervention group before and after the intervention:T1 (baseline) compared to T2 (2-4 weeks after the intervention)T1 (baseline) compared to T3 (6-8 months after the intervention); in the intervention group compared to the control group at:T2 (2-4 weeks after the intervention)T3 (6-8 months after the intervention) The outcomes will be analyzed statistically based on the different answers in the questionnaire and regional differences.	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)	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. Difference in iodine awareness of the healthcare professional is examined before and after the training: - T1 (baseline) compared to T2 (2-4 weeks after the intervention)	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)	Dietary iodine intake is assessed through a food frequency questionnaire (FFQ), covering five main categories (cow's milk, fish, eggs, supplements, and salt) and regional components in each country. Each category is scored based on frequency (portions per day, week, or month), and individual sources are analyzed for iodine intake. Difference in the FFQ of healthcare professional is compared before and after the training: - T1 (baseline) compared to T2 (2-4 weeks after the intervention)	T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)

Collaborators and Investigators

• Sponsor: EUthyroid
• Collaborators: UK Research and Innovation; EU Horizon

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: nutrition; prevention; education; intervention study; awareness; complex intervention; cluster-randomized controlled trial; iodine deficiency; adaption to context; urinary iodine status; iodine intake
• Additional Relevant MeSH Terms: Anti-Infective Agents; Physiological Effects of Drugs; Trace Elements; Micronutrients; Anti-Infective Agents, Local; Iodine
• Other Study ID Numbers: 101095643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No