m-Health intervention for physical activity among patients with type 2 diabetes mellitus in India: a randomized controlled trial

Physical Inactivity is a modifiable risk factor for Type 2 Diabetes Mellitus (T2DM). Promoting physical activity (PA) through recent behaviour change communication (BCC) strategies like Nudge Theory (NT) can lead to better glycaemic control and hence prevent complications of uncontrolled diabetes in patients of T2DM. Moreover, m-health intervention can offer innovative solutions to ensure adherence to physical activity at affordable cost and meagre resources, especially in resource constraint country like India. This research aimed to study the effect of m-health intervention using NT for delivery of PA among patients visiting Non-Communicable Diseases (NCD) health clinic in a rural secondary care level health facility in Delhi, India. This 1 year-long research was a 4-month intervention, single-centre, single blinded, parallel-group randomized controlled trial among patients of T2DM of age group 30 to 59 years. Consecutive enrolment was done till the required sample size was reached and then the participants were randomized into control and intervention group. The control group received Information, Education and Communication (IEC) messages while the intervention group received personalized, tailored nudge messages, twice a week on WhatsApp sent by the principal investigator. The step counts were recorded using Google-fit app installed in the personal smartphones of the participants. Random Blood Sugar (RBS) and HbA1C were measured before and after intervention to correlate the effect of PA on glycaemic control of the participants. An intention-to-treat analysis was done. After 4 months of intervention, the control group showed an increment of 319.84 ± 259.34 (+ 8.3%) mean steps per day while the intervention group showed an increment of 1452.10 ± 717.25 (39.3%) steps per day. Post intervention, there was no significant change in RBS and HbA1C of the control group however in the intervention group there was mean decline in the RBS level by -15.64 ± 33.17 mg/dL ( p = 0.002) and HbA1C level by -0.90 ± 0.77% [9.36%] ( p < 0.001). m-health was effective in delivering behaviour change intervention to increase PA among the intervention group. Thus, it also helped in lowering the glycaemic levels in the intervention group. Diabetes being a chronic disease requires long term monitoring and medication for proper management of the disease. In this context, m-health can provide novel solutions in the form of provision of remote healthcare management. The trial was prospectively registered at the Clinical Trial Registry of India (CTRI) on 11th September, 2023. The registration number is CTRI/2023/09/057429.