Clinical trial NCT06769009: EUthyroid2: 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
cluster-randomized controlled trial
complex intervention
adaption to context
awareness
urinary iodine status
iodine intake
nutrition
education
Lead sponsor: EUthyroid
Sponsor class: OTHER
Collaborators: name: EU Horizon
name: UK Research and Innovation
First posted: 2025-01-10
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Significant change in awareness of iodine of healthcare professionals before (T1) and after the training (T2)
timeFrame: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
measure: Significant change in intake of dietary iodine sources of the healthcare professional before (T1) and after the training (T2)
timeFrame: T1 = baseline (before the training); T2 = follow-up (2-4 weeks after the training)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangladesh University of Health
city: Bergen
country: Norway
facility: Institute of Marine Research
city: Peshawar
country: Pakistan
facility: Islamia College Peshawar
state: Khyber Pakhtunkhwa
city: Krakow
country: Poland
facility: Jagiellonian University
city: Belfast
country: United Kingdom
facility: The Queen's University of Belfast
city: Guildford
country: United Kingdom
facility: University of Surrey
Study officials:
References: