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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Chronic Disease
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 634

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE4 5pW
    • University Hospitals of Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic disease risk factor - Body mass index (BMI)	Height and weight will be measured to calculated BMI	12 months

Secondary Outcome Measures

Outcome Measure	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)		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

Other Outcome Measures

Outcome Measure	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.	18 months

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester
• Collaborators: University of Leipzig; Technische Universität Dresden; University of Leicester; The Algarve Regional Health Administration; Alexander Technological Educational Institute, Thessaloniki, Greece; Diabetes Centre of Paediatrics P&A; Primary Care Centre Egia, San Sebastian, Spain; Basque Government Department of Public Health; Health Department of the Alto/Bajo Deba; Athens General Children's Hospital "Pan. & Aglaia Kyriakou"; Associacao Protectora dos Diabeticos de Portugal
• Investigators: Principal Investigator: Melanie J Davies, MD, University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: risk factors; adolescents; screening
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Chronic Disease
• Other Study ID Numbers: 173431