Prevention Strategies for Adolescents at Risk of Diabetes
- Conditions
- Type 2 DiabetesChronic Disease
- Interventions
- Other: No intervention
- Registration Number
- NCT02545140
- Lead Sponsor
- University Hospitals, Leicester
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
- Young people aged between 12-14 years of age
- be willing and able to give assent
- have obtained written parent/guardian consent.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UK (Lead Site) No intervention 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)
- Primary Outcome Measures
Name Time Method Chronic disease risk factor - Body mass index (BMI) 12 months Height and weight will be measured to calculated BMI
- Secondary Outcome Measures
Name Time Method 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 Fasted and/or unfasted
Chronic disease risk factor - triglycerides 12 months Chronic disease risk factor - blood pressure 12 months Chronic disease risk factor - low density lipoprotein cholesterol 12 months Calculated
Chronic disease risk factor - total cholesterol 12 months
Trial Locations
- Locations (1)
University Hospitals of Leicester
🇬🇧Leicester, United Kingdom