Prevention Strategies for Adolescents at Risk of Diabetes (PRE-STARt)
Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
研究概览
详细说明
Data will be collected in 5 European Commission countries (500 adolescents in total). A range of biological and lifestyle measures will be collected in order to investigate the adolescent's lifestyle and will include body weight and other anthropometric measurements, blood pressure, blood capillary sample, self-reported physical activity, sedentary behaviour and dietary habits. Their parent/guardian will complete a number of questions to gather information about variables that have been associated with chronic disease (including type 2 diabetes) and include peri-natal history (birth weight, gestational diabetes), socioeconomic status, family health and medical history.
A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future has been developed systematic review results and a Delphi procedure. This draft tool will be evaluated and refined. This draft risk tool will be evaluated by independent clinical reviewers against the data collected from the 500 adolescent data sets. The results for each adolescent will be independently reviewed by clinicians who will assign either a "lower" or "higher" risk to each case. The results will be compared to the results from the draft 'PRE-START tool', used to further refine this identification tool using appropriate statistical methods.
The outputs of this study will be a fit for purpose 'PRE-STARt tool' that can be used for recruitment to interventional studies whose primary objective is to reduce the risk of developing chronic disease (including type 2 diabetes) in the future.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Leicester、英国、LE4 5pW
- University Hospitals of Leicester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Young people aged between 12-14 years of age
- be willing and able to give assent
- have obtained written parent/guardian consent.
Exclusion Criteria:
- are outside the age range of interest (i.e. aged less than 12 years or greater than 14 years of age)
- do not have parental consent or do not give assent
- have an existing diagnosis of type 1 or type 2 diabetes
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
UK (Lead Site)
Data will be collected from 100 adolescents from each participating site providing clinical data for 500 adolescents providing a cross-sectional cohort from each of the following countries: UK (Lead Site) Germany Portugal Greece Spain (Basque Country) |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Chronic disease risk factor - Body mass index (BMI)
大体时间:12 months
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Height and weight will be measured to calculated BMI
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Chronic disease risk factor - waist circumference
大体时间:12 months
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12 months
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Chronic disease risk factor - blood pressure
大体时间:12 months
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12 months
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Chronic disease risk factor - glycated haemoglobin (HbA1c)
大体时间:12 months
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12 months
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Chronic disease risk factor - high density lipoprotein cholesterol
大体时间:12 months
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12 months
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Chronic disease risk factor - glucose
大体时间:12 months
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Fasted and/or unfasted
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12 months
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Chronic disease risk factor - low density lipoprotein cholesterol
大体时间:12 months
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Calculated
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12 months
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Chronic disease risk factor - triglycerides
大体时间:12 months
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12 months
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Chronic disease risk factor - total cholesterol
大体时间:12 months
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12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Risk tool refinement
大体时间:18 months
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A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future that has been developed systematic review results and a Delphi procedure.
Each adolescent will complete a diet and lifestyle questionnaire about their physical activity, sedentary behaviour and dietary habits and the parent/guardian will complete a questionnaire about their family health history and about their child's early years (including gestational period, birth weight, whether they were breast or bottle fed).
This draft tool will be evaluated and refined using these data and the data from the assessments mentioned in 1-9.
The draft risk tool will then be refined based on data from the 500 adolescents using appropriate statistical methods resulting in an externally validated risk tool that can be used to screen young people aged between 12-14 years for being at risk of developing of type 2 diabetes in the future.
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18 months
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合作者和调查者
合作者
调查人员
- 首席研究员:Melanie J Davies, MD、University Hospitals, Leicester
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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