Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University Hospitals, Leicester
- Enrollment
- 634
- Locations
- 1
- Primary Endpoint
- Chronic disease risk factor - Body mass index (BMI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Chronic disease risk factor - Body mass index (BMI)
Time Frame: 12 months
Height and weight will be measured to calculated BMI
Secondary Outcomes
- 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)