Clinical trial NCT02545140: Prevention Strategies for Adolescents at Risk of Diabetes
Official title: Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Chronic Disease
Keywords: risk factors
screening
adolescents
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: Associacao Protectora dos Diabeticos de Portugal
name: The Algarve Regional Health Administration
name: University of Leipzig
name: Technische Universität Dresden
name: Alexander Technological Educational Institute, Thessaloniki, Greece
name: Diabetes Centre of Paediatrics P&A
name: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
name: Primary Care Centre Egia, San Sebastian, Spain
name: Basque Government Department of Public Health
name: Health Department of the Alto/Bajo Deba
First posted: 2015-09-09
Enrollment: 634
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chronic disease risk factor - Body mass index (BMI)
timeFrame: 12 months
Secondary outcomes:
measure: Chronic disease risk factor - waist circumference
timeFrame: 12 months
measure: Chronic disease risk factor - blood pressure
timeFrame: 12 months
measure: Chronic disease risk factor - glycated haemoglobin (HbA1c)
timeFrame: 12 months
measure: Chronic disease risk factor - high density lipoprotein cholesterol
timeFrame: 12 months
measure: Chronic disease risk factor - glucose
timeFrame: 12 months
measure: Chronic disease risk factor - low density lipoprotein cholesterol
timeFrame: 12 months
measure: Chronic disease risk factor - triglycerides
timeFrame: 12 months
measure: Chronic disease risk factor - total cholesterol
timeFrame: 12 months
Other outcomes:
measure: Risk tool refinement
timeFrame: 18 months
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: University Hospitals, Leicester
name: Melanie J Davies, MD
role: PRINCIPAL_INVESTIGATOR
References: