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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-24
SponsorEUthyroid

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Having a thyroid disease

Pregnancy at the timepoint of recruitment and during the intervention period

Lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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)

Time frame
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

1

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: 1. 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) 2. in the intervention group compared to the control group at: * T2 (2-4 weeks after the intervention) * T3 (6-8 months after the intervention)

Time frame
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)
2

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: 1. 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) 2. 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.

Time frame
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)
3

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)

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

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EUthyroid

Lead sponsor

EU Horizon

Collaborator

UK Research and Innovation

Collaborator