Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Leicester | OTHER |
| Associacao Protectora dos Diabeticos de Portugal | OTHER |
| The Algarve Regional Health Administration | OTHER |
| University of Leipzig |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UK (Lead Site) | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic disease risk factor - Body mass index (BMI) | Height and weight will be measured to calculated BMI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic disease risk factor - waist circumference | 12 months | |
| Chronic disease risk factor - blood pressure | 12 months | |
| Chronic disease risk factor - glycated haemoglobin (HbA1c) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk tool refinement | 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis of type 1 or type 2 diabetes.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melanie J Davies, MD | University Hospitals, Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester | Leicester | LE4 5pW | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| OTHER |
| Technische Universität Dresden | OTHER |
| Alexander Technological Educational Institute, Thessaloniki, Greece | OTHER |
| Diabetes Centre of Paediatrics P&A | UNKNOWN |
| Athens General Children's Hospital "Pan. & Aglaia Kyriakou" | OTHER |
| Primary Care Centre Egia, San Sebastian, Spain | UNKNOWN |
| Basque Government Department of Public Health | OTHER |
| Health Department of the Alto/Bajo Deba | OTHER |
Not provided
Not provided
Not provided
| 12 months |
| Chronic disease risk factor - high density lipoprotein cholesterol | 12 months |
| Chronic disease risk factor - glucose | Fasted and/or unfasted | 12 months |
| Chronic disease risk factor - low density lipoprotein cholesterol | Calculated | 12 months |
| Chronic disease risk factor - triglycerides | 12 months |
| Chronic disease risk factor - total cholesterol | 12 months |
| 18 months |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |