Diabetes and Endocrinology, Imperial College London St Mary’s Hospital Campus, Norfolk Place, London, W2 1PG, UK
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Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK
- Published on Sept. 10, 2018
Background: 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. 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/Design: This 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.
Discussion: 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.
- Hazel Thomson 1
- Nick Oliver 1
- Ian F. Godsland 1
- Ara Darzi 2
- Weerachai Srivanichakorn 1,3
- Azeem Majeed 4
- Desmond G. Johnston 1
- Arun Nanditha 5
- Chamukuttan Snehalatha 5
- Arun Raghavan 5
- Priscilla Susairaj 5
- Mary Simon 5
- Krishnamoorthy Satheesh 5
- Ambady Ramachandran 5
- Stephen Sharp 6
- Kate Westgate 6
- Søren Brage 6
- Nick Wareham 6
Department of Surgery and Cancer, Imperial College London, St Mary’s Hospital Campus, Norfolk Place, London, W2 1PG, UK
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand
Primary Care and Public Health, Imperial College London Charing Cross Hospital Campus, Reynolds Building, Hammersmith, London, w6 8RP, UK
India Diabetes Research Foundation and Dr. A. Ramachandran’s Diabetes Hospitals, Chennai, 28 Marshalls Road, Egmore, Chennai, 600 008, India
MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0SL, UK
BMC Endocrine Disorders