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.