Title: The PRmotion Of Physical activity through structured Education with differing Levels of ongoing Support for those with prediabetes (PROPELS): randomised controlled trial in a diverse multi-ethnic community
Funder: Department of Health and Social Care

Abstract: BACKGROUND Type 2 diabetes exerts a huge health and economic burden within the United Kingdom. Increasing levels of physical inactivity are one of the main causes of the growing prevalence of type 2 diabetes. However, evidenced-based approaches to promoting increased physical activity in the prevention diabetes are lacking. This study aims to bridge this gap in the evidence. DESIGN Randomized controlled trial; follow-up at 12 & 48 months. METHODS 1308 individuals aged 40-75 years and identified with impaired glucose regulation will be recruited from the community and primary care settings in the East-Midlands and East Anglia. Around 25% of recruited participants will be from a south Asian ethnic origin. Individuals will be randomized (1:1:1) to: 1) Detailed advice leaflet (control). 2) A 3.5-hour group-based structured education programme followed by annual group-based or telephone support up to 36 months. The initial structured education session is delivered by two trained educators and aimed at targeting perceptions of IGR and promoting physical activity with pedometer use. South Asian individuals will receive the option of attending a version specifically tailored to their language and cultural needs. 3) The same behaviour change intervention as group 2, including annual group sessions, plus ongoing support delivered by telephone contact, text messaging, email, and web-based action planning facilities: weekly in the first 6 months and monthly thereafter. RESULTS and ANALYSIS Outcomes will include: objectively measured physical activity, fasting and 2-h post-challenge glucose, progression to type 2 diabetes, HbA1c, lipids, standard anthropometric measurements, diet, quality of life and depression. Detailed cost-effectiveness modelling will also be undertaken using an adaptation of the Sheffield Diabetes Model. Analysis will involve two comparisons; both intervention groups will be compared to the control group. Should any of these comparisons reveal a significant difference then a third a priori comparison will be undertaken by directly comparing intervention groups. Data will be analysed using a robust predefined plan. CONCLUSIONS This study is one of the most rigorous long-term physical activity intervention ever undertaken globally in a high risk population. It will help ensure that pragmatic evidenced-based behaviour change interventions, evaluated to the same rigorous standards as pharmaceutical products, are available for consideration by regulatory bodies and primary care organisations.

Lay abstract: BACKGROUND One of the main reasons that more people are getting diabetes is that people are not getting enough exercise (physical activity). However, we still don’t know enough about the best way to get people – especially people who are at most risk of developing diabetes – to be more physically active. The aim of this study is to test alternative versions of an intervention designed to increase physical activity within a diverse multi-ethnic population who have a high risk of diabetes. METHODS We will identify and recruit 1308 individuals with a high risk of diabetes from the East-Midlands and East Anglia. Recruited participants will be randomly allocated (a bit like tossing a coin) to one of the following three intervention conditions; (i) Receive a detailed advice leaflet (the control group). (ii) Receive a specifically developed 3.5 hour group-based intervention to provide participants with an accurate understand of some of the key issues involved with having a high risk of diabetes and to help them find ways of increasing their physical activity levels in their own environments. It includes a version that has been specifically tailored to the language and cultural needs of South Asians. This programme will be supplemented with annual telephone or group-based support (depending on the preferences of the individual). (iii) Receive the same intervention as group 2; however, the programme will be supplemented with monthly support via telephone and multimedia sources (i.e. interne and, mobile phone technology). Physical activity level (measured objectively using best practice by a small accelerometer worn around the waist) and the risk of developing type 2 diabetes (measured through blood glucose levels) and other important outcomes will then be assessed within each group at 12 and 36 months. This will help establish how effective each programme is at promoting physical activity and improving health. In addition, we will establish whether each programme provides good value for money when run within the NHS. CONCLUSIONS If successful, this programme will have important implications for the NHS as it will provide an evidence-based approach to promoting physical activity in those with a high risk of type 2 diabetes.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: METABOLIC AND ENDOCRINE