- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02545140
Prevention Strategies for Adolescents at Risk of Diabetes (PRE-STARt)
Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Leicester, Storbritannien, LE4 5pW
- University Hospitals of Leicester
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Chronic disease risk factor - Body mass index (BMI)
Tidsram: 12 months
|
Height and weight will be measured to calculated BMI
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Chronic disease risk factor - waist circumference
Tidsram: 12 months
|
12 months
|
|
Chronic disease risk factor - blood pressure
Tidsram: 12 months
|
12 months
|
|
Chronic disease risk factor - glycated haemoglobin (HbA1c)
Tidsram: 12 months
|
12 months
|
|
Chronic disease risk factor - high density lipoprotein cholesterol
Tidsram: 12 months
|
12 months
|
|
Chronic disease risk factor - glucose
Tidsram: 12 months
|
Fasted and/or unfasted
|
12 months
|
Chronic disease risk factor - low density lipoprotein cholesterol
Tidsram: 12 months
|
Calculated
|
12 months
|
Chronic disease risk factor - triglycerides
Tidsram: 12 months
|
12 months
|
|
Chronic disease risk factor - total cholesterol
Tidsram: 12 months
|
12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Risk tool refinement
Tidsram: 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.
|
18 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Melanie J Davies, MD, University Hospitals, Leicester
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 173431
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