The PRE-STARt Study
Research type
Research Study
Full title
PREvention STrategies for Adolescents at Risk of diabetes - A pilot study across 5 European countries.
IRAS ID
163346
Contact name
Melanie Davies
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The study aims to evaluate and refine a screening tool that is able to identify young people between the ages of 12 and 14 years who may be at a higher risk of developing Type 2 Diabetes Mellitus in the future. Diabetes (and more specifically, Type 2 diabetes) is a serious health condition normally associated with older age, but increases in unhealthy diets and the modern sedentary lifestyle are thought to be major contributing factors to the sharp increase in the number of young people being diagnosed with this disease. The disease can cause problems with the eyes (retinopathy), heart (cardiovascular disease), kidneys (nephropathy), and nerves and feet (neuropathy) and is a significant health care burden because it accounts for between 7% and 14% of the total health care expenditure across the UK. Therefore, the ability to screen for, and identify, those who may be at risk of developing this disease as early as possible is important if we are going to help reduce its incidence and prevent it. We have developed a screening tool but it needs to be evaluated and refined before it is used to identify ‘at risk’ adolescents to participate in an interactive lifestyle and diabetes prevention programme consisting of 8 one hour sessions delivered in a group setting. The content of the sessions will vary to cover food swaps, label reading, increasing physical activity. We wish to find out whether this programme will help to reduce their initial risk over a period of 12 months. We hope to see an increase in physical activity, less sedentary behaviour, healthier food choices and a reduction in clinically significant signs (i.e., blood glucose levels). We will measure these factors 6 and 12 months after participants have entered the study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1251
Date of REC Opinion
28 Nov 2014
REC opinion
Unfavourable Opinion