A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial

Abstract

Aims/hypothesis: This 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.

Methods: The 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.

Results: At 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/interpretation: This 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 registration: The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833).

Funding: The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.

Keywords: Behavioural change; Diabetes prevention; Glycosylated haemoglobin A1c; Lifestyle modification; Mobile technology; Prediabetes; Screening; Short message service.

Figures

Fig. 1

CONSORT diagram of trial profile. FPG, fasting plasma glucose

Fig. 2

Cumulative percentage of individuals with type 2 diabetes at each follow-up visit

Fig. 3

Effect of intervention on primary outcome (the development of type 2 diabetes) overall (p = 0.22) and by pre-specified subgroups (intervention × country interaction: p = 0.33; intervention × sex interaction: p = 0.12)

Fig. 4

Overall effect of intervention on secondary outcomes (n = 2062). Intervention effects represent differences between intervention and control groups, estimated from a linear regression model with random intercepts at the individual level, using measures of the outcome at all follow-up times, and including baseline value of the outcome, country, randomised group and time (months of follow-up). Intervention effects are presented in units of baseline SD of each outcome. Triacylglycerol results are presented using log-transformed values. MVPA, moderate-to-vigorous physical activity