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Completed

NCT Number: NCT02545140

Prevention Strategies for Adolescents at Risk of Diabetes

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).

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Key information

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Leicester

Leicester, LE4 5pW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Chronic disease risk factor - Body mass index (BMI)

    Time frame: 12 months

    Height and weight will be measured to calculated BMI

Secondary outcomes

  1. Chronic disease risk factor - waist circumference

    Time frame: 12 months

  2. Chronic disease risk factor - blood pressure

    Time frame: 12 months

  3. Chronic disease risk factor - glycated haemoglobin (HbA1c)

    Time frame: 12 months

  4. Chronic disease risk factor - high density lipoprotein cholesterol

    Time frame: 12 months

  5. Chronic disease risk factor - glucose

    Time frame: 12 months

    Fasted and/or unfasted

  6. Chronic disease risk factor - low density lipoprotein cholesterol

    Time frame: 12 months

    Calculated

  7. Chronic disease risk factor - triglycerides

    Time frame: 12 months

  8. Chronic disease risk factor - total cholesterol

    Time frame: 12 months

Other outcomes

  1. Risk tool refinement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

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

Registry information

Official study title

Prevention Strategies for Adolescents at Risk of Diabetes - Validation of a Risk Tool for Young People Aged 12 - 14 Years

Acronym: PRE-STARt

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2015
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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