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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Educational intervention measures on iodine, iodine deficiency and iodine intake
BehavioralThe 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
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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.
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)
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.