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Prevention Strategies for Adolescents at Risk of Diabetes (PRE-STARt)

2019年1月14日 更新者:University Hospitals, Leicester

Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years

The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes).

研究概览

地位

完全的

干预/治疗

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

观察性的

注册 (实际的)

634

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Leicester、英国、LE4 5pW
        • University Hospitals of Leicester

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 14年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis of type 1 or type 2 diabetes.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
Chronic disease risk factor - Body mass index (BMI)
大体时间:12 months
Height and weight will be measured to calculated BMI
12 months

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
12 months
Chronic disease risk factor - blood pressure
大体时间:12 months
12 months
Chronic disease risk factor - glycated haemoglobin (HbA1c)
大体时间:12 months
12 months
Chronic disease risk factor - high density lipoprotein cholesterol
大体时间:12 months
12 months
Chronic disease risk factor - glucose
大体时间:12 months
Fasted and/or unfasted
12 months
Chronic disease risk factor - low density lipoprotein cholesterol
大体时间:12 months
Calculated
12 months
Chronic disease risk factor - triglycerides
大体时间:12 months
12 months
Chronic disease risk factor - total cholesterol
大体时间:12 months
12 months

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
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.
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2015年9月7日

首先提交符合 QC 标准的

2015年9月7日

首次发布 (估计)

2015年9月9日

研究记录更新

最后更新发布 (实际的)

2019年1月15日

上次提交的符合 QC 标准的更新

2019年1月14日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

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.

2型糖尿病的临床试验

无干预的临床试验

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