Abstract
Aims/hypothesisThis randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes.MethodsThe study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35–55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40–74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2–3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life.ResultsAt the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes.Conclusions/interpretationThis trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging.Trial registrationThe primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833).FundingThe study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.
Highlights
The public health challenge of type 2 diabetes is set to worsen as the prevalence rises from 425 million people globally in 2017 to 629 million by 2045 [1]
In a previous RCT in India, we demonstrated that the delivery of a package of customised, tailored short message service (SMS) messages based on the transtheoretical model (TTM) of behaviour change was effective compared with standard care, reducing the incidence of type 2 diabetes by 36% over 2 years [9]
Mobile technology is being widely applied in clinical management of a variety of long-term chronic disorders [6, 7, 10, 11, 24, 25] and in modifying behaviour patterns such as smoking [26], the number of randomised intermediate and long-term studies in prevention of diabetes is limited
Summary
The public health challenge of type 2 diabetes is set to worsen as the prevalence rises from 425 million people globally in 2017 to 629 million by 2045 [1]. The interventions in the initial diabetes prevention RCTs were labour intensive and difficult to scale up to reach large numbers of people at risk. In a previous RCT in India, we demonstrated that the delivery of a package of customised, tailored SMS messages based on the transtheoretical model (TTM) of behaviour change was effective compared with standard care, reducing the incidence of type 2 diabetes by 36% over 2 years [9]. In that RCT we recruited working Asian Indian men with persistent prediabetes defined as impaired glucose tolerance on two OGTTs. In that RCT we recruited working Asian Indian men with persistent prediabetes defined as impaired glucose tolerance on two OGTTs This method for defining prediabetes (and for assessing progression to diabetes) is time consuming for participants and the healthcare system and is difficult to scale up at societal level
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