NCT02545140

Prevention Strategies for Adolescents at Risk of Diabetes

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 634 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 12 Years – 14 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Type 2 Diabetes
• Chronic Disease

Interventions

Type	Name	Description
OTHER	No intervention

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-09
• Last updated: 2019-01-15

Locations

1 site across 1 country: United Kingdom