Phase III Cluster-Randomised Community Study of Stroke RiskometerBased Lifestyle Intervention across Five Indian States for Stroke Risk Reduction at 12 Months - PROMOTE India Study
Rajinder Dhamija1, PN Sylaja2, Balakrishnan Nair3, Rita Krishnamurthi3, Michael Kravchenko3, Valery Feigin3
1Department of neurology, Institute of Human Behavior and Allied Sciences New Delhi, 2Department of neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, 3Faculty of Health, National Institute for Stroke and Applied Neurosciences, Auckland University of Technology
Objective:
To assess the effectiveness of a Stroke Riskometer based digital lifestyle intervention in reducing systolic blood pressure and improving behavioural and physiological stroke risk indicators among 15,000 adults aged 40 to 75 years out of 50,000 screened across five Indian states.
Background:
Stroke is a major cause of death and disability in India, often occurring in individuals with low to borderline cardiovascular disease (CVD) risk groups missed by current high-risk-focused strategies. Despite growing global evidence on digital lifestyle tools like the Stroke Riskometer, there is limited implementation evidence on their feasibility and effectiveness across all CVD risk levels in diverse Indian settings. This will be the first large-scale, community-based implementation study in India evaluating a validated Stroke Riskometer digital tool for primary stroke prevention in adults at any level of increased CVD risk. The approach integrates personalised risk assessment and lifestyle guidance into a scalable, digital-first model embedded within the public health system.
Design/Methods:
A cluster randomised, community level implementation trial will be conducted across 20 clusters (4 clusters per state), allocated in a 3:1 ratio to intervention and control. Health care workers will deliver digital risk profiling, lifestyle counselling, and follow-up support. Outcomes will be evaluated at 12 months using Life’s Simple 7 and Life Essential 8 scores, clinical data, and behavioural indicators.
Results:
The Promote India cluster RCT study will generate critical evidence on the feasibility, scalability, and effectiveness of a digital lifestyle intervention within India's public health system, with anticipated benefits extending to stroke and other major non-communicable diseases.
Conclusions:
This study is positioned to deliver actionable evidence that a digital first, clinician led, community delivered prevention model can measurably reduce modifiable stroke risk at scale and provide a transferrable template for broader brain-health prevention initiatives.
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