Type 2 Diabetes Clinical Trial
Official title:
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).
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.
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