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

Hazel Thomson, Nick Oliver, Ian F Godsland, Ara Darzi, Weerachai Srivanichakorn, Azeem Majeed, Desmond G Johnston, Arun Nanditha, Chamukuttan Snehalatha, Arun Raghavan, Priscilla Susairaj, Mary Simon, Krishnamoorthy Satheesh, Ambady Ramachandran, Stephen Sharp, Kate Westgate, Søren Brage, Nick Wareham, Hazel Thomson, Nick Oliver, Ian F Godsland, Ara Darzi, Weerachai Srivanichakorn, Azeem Majeed, Desmond G Johnston, Arun Nanditha, Chamukuttan Snehalatha, Arun Raghavan, Priscilla Susairaj, Mary Simon, Krishnamoorthy Satheesh, Ambady Ramachandran, Stephen Sharp, Kate Westgate, Søren Brage, Nick Wareham

Abstract

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.

Trial registration: ClinicalTrials.gov ; NCT01570946 , 4th April 2012 (India); NCT01795833 , 21st February 2013 (UK).

Keywords: Diabetes prevention; HbA1c; Prediabetes; Randomised controlled trial; Short messaging service.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approvals were received from Westminster Ethics Committee (12/LO/1322) in the UK and from the Ethics Committee of the India Diabetes Research Foundation (ECR/254/Inst/TN/2013) in India. Study protocol amendments are reviewed for approval by ethics committees when necessary. Written consent is obtained from each participant after full explanation, an information leaflet offered and time allowed for consideration. The right of the participant to refuse to participate, or continue participating, without giving reasons and without prejudicing further treatment is respected. The Chief Investigator in each country ensures that participant confidentiality is respected and local data protection requirements are met.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Recruitment flowchart in India and the UK
Fig. 2
Fig. 2
Clinical assessments and other activities at each visit

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