Chronic Disease, Type 2 Diabetes
Conditions
Keywords
risk factors, screening, adolescents
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.
Interventions
OTHERNo intervention
Sponsors
University of Leicester
Associacao Protectora dos Diabeticos de Portugal
The Algarve Regional Health Administration
University of Leipzig
Technische Universität Dresden
Alexander Technological Educational Institute, Thessaloniki, Greece
Diabetes Centre of Paediatrics P&A
Athens General Children's Hospital Pan. & Aglaia Kyriakou
Primary Care Centre Egia, San Sebastian, Spain
Basque Government Department of Public Health
Health Department of the Alto/Bajo Deba
University Hospitals, Leicester
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic disease risk factor - Body mass index (BMI) | 12 months | Height and weight will be measured to calculated BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic disease risk factor - waist circumference | 12 months | — |
| Chronic disease risk factor - blood pressure | 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 - low density lipoprotein cholesterol | 12 months | Calculated |
| Chronic disease risk factor - triglycerides | 12 months | — |
| Chronic disease risk factor - total cholesterol | 12 months | — |
| Chronic disease risk factor - glucose | 12 months | Fasted and/or unfasted |
Other
| Measure | Time frame | Description |
|---|---|---|
| Risk tool refinement | 18 months | A draft risk tool to identify those children with a 'higher risk' of developing type 2 diabetes in the future that has been developed systematic review results and a Delphi procedure. Each adolescent will complete a diet and lifestyle questionnaire about their physical activity, sedentary behaviour and dietary habits and the parent/guardian will complete a questionnaire about their family health history and about their child's early years (including gestational period, birth weight, whether they were breast or bottle fed). This draft tool will be evaluated and refined using these data and the data from the assessments mentioned in 1-9. The draft risk tool will then be refined based on data from the 500 adolescents using appropriate statistical methods resulting in an externally validated risk tool that can be used to screen young people aged between 12-14 years for being at risk of developing of type 2 diabetes in the future. |
Countries
United Kingdom
Outcome results
None listed