Abstract
BackgroundType 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. However, implementing lifestyle modification programmes to high risk groups is expensive and alternative cheaper methods are needed. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. The aim of the study is to assess the efficacy and user acceptability of text messaging employed in this way for people with pre-diabetes (HbA1c 6.0% to ≤6.4%; 42–47 mmol/mol) in the UK and India.Methods/designThis is a randomised, controlled trial with participants followed up for 2 years. After being screened and receiving a structured education programme for prediabetes, participants are randomised to a control or intervention group. In the intervention group, text messages are delivered 2–3 times weekly and contain educational, motivational and supportive content on diet, physical activity, lifestyle and smoking. The control group undergoes monitoring only. In India, the trial involves 5 visits after screening (0, 6, 12, 18 and 24 months). In the UK there are 4 visits after screening (0, 6, 12 and 24 months). Questionnaires (EQ-5D, RPAQ, Transtheoretical Model of Behavioural Change, and food frequency (UK)/24 h dietary recall (India)) and physical activity monitors (Actigraph GT3X+ accelerometers) are assessed at baseline and all follow-up visits. The SMS acceptability questionnaires are evaluated in all follow-up visits. The primary outcome is progression to type 2 diabetes as defined by an HbA1c of 6.5% or over(India) and by any WHO criterion(UK). Secondary outcomes are the changes in body weight, body mass index, waist circumference, blood pressure, fasting plasma glucose; lipids; proportion of participants achieving HbA1c ≤6.0%; HOMA-IR; HOMA-β; acceptability of SMS; dietary parameters; physical activity and quality of life.DiscussionThe study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries.Trial registrationClinicalTrials.gov; NCT01570946, 4th April 2012 (India); NCT01795833, 21st February 2013 (UK).
Highlights
Type 2 diabetes is a serious clinical problem in both India and the UK
The study is designed to assess the efficacy of tailored text messaging in addition to standard lifestyle advice to reduce the progression from prediabetes to type 2 diabetes in the two different countries
A major challenge in applying high risk individuallevel diabetes prevention strategies to large sub-groups within the population is that the successful lifestyle modification interventions employed in clinical trials are labour intensive and expensive and difficult to operationalise at scale
Summary
Type 2 diabetes is a serious clinical problem in both India and the UK. Adoption of a healthy lifestyle through dietary and physical activity modification can help prevent type 2 diabetes. We are using a short messaging service (SMS) programme in our study as a tool to provide healthy lifestyle advice and an aid to motivation. A large proportion of both populations have intermediate levels of hyperglycaemia, or so-called pre-diabetes, and this constitutes an identifiable subgroup who are at high risk of progression to diabetes [5,6,7] and in whom preventive interventions have been shown to be effective [8,9,10,11,12]. A major challenge in applying high risk individuallevel diabetes prevention strategies to large sub-groups within the population is that the successful lifestyle modification interventions employed in clinical trials are labour intensive and expensive and difficult to operationalise at scale. Our intervention strategy attempts to overcome this issue of scalability by employing a lifestyle modification programme delivered by short messaging service (SMS) in both India and the UK. Text messaging is cheap and feasible and has been successfully used to modify behaviour in other contexts such as smoking cessation [13, 14]
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