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临床试验/NCT02545140
NCT02545140已完成不适用

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

University Hospitals, Leicester1 个研究点 分布在 1 个国家目标入组 634 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
634
试验地点
1
主要终点
Chronic disease risk factor - Body mass index (BMI)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Young people aged between 12-14 years of age
  • be willing and able to give assent
  • have obtained written parent/guardian consent.

排除标准

  • 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

结局指标

主要结局

Chronic disease risk factor - Body mass index (BMI)

时间窗: 12 months

Height and weight will be measured to calculated BMI

次要结局

  • Chronic disease risk factor - blood pressure(12 months)
  • Chronic disease risk factor - waist circumference(12 months)
  • Chronic disease risk factor - glycated haemoglobin (HbA1c)(12 months)
  • Chronic disease risk factor - high density lipoprotein cholesterol(12 months)
  • Chronic disease risk factor - glucose(12 months)
  • Chronic disease risk factor - triglycerides(12 months)
  • Chronic disease risk factor - low density lipoprotein cholesterol(12 months)
  • Chronic disease risk factor - total cholesterol(12 months)

研究者

发起方
University Hospitals, Leicester
申办方类型
Other
责任方
Sponsor

研究点 (1)

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