跳至主要内容
临床试验/NCT06769009
NCT06769009招募中不适用

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

EUthyroid6 个研究点 分布在 5 个国家目标入组 1,000 人开始时间: 2024年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
6
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Intervention Group

Experimental

干预措施: Educational intervention measures on iodine, iodine deficiency and iodine intake (Behavioral)

Control group

No Intervention

结局指标

主要结局

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.

时间窗: 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)

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)

次要结局

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

研究者

发起方
EUthyroid
申办方类型
Other
责任方
Sponsor

研究点 (6)

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