Prevention Strategies for Adolescents at Risk of Diabetes (PRE-STARt)

NHS Trust

Status: Completed

Conditions: Chronic Disease; Type 2 Diabetes

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02545140

173431

Details and patient eligibility

About

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).

Full 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.

Enrollment: 634 patients

Sex: All

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

634 participants in 1 patient group

UK (Lead Site)

Description:

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)

Treatment:

Other: No intervention