Indians carry a disproportionate burden of cardiometabolic disease, developing coronary heart disease roughly a decade earlier than Western populations and with distinct metabolic risk profiles. Whether a structured, non-pharmacological lifestyle program can meaningfully move the needle when two or more conditions — diabetes, hypertension, stroke, or coronary disease — co-exist in the same patient remains poorly tested in this demographic context. That gap is precisely what the SHRADDHA-CMM protocol is designed to address.
The trial is a two-arm, non-blinded cluster randomised controlled trial embedded in the ENDIRA cohort in Ernakulam, Kerala, enrolling adults aged 18 and older who meet the definition of cardiometabolic multimorbidity (CMM) — concurrent diagnosis of at least two of the four target conditions. The SHRADDHA lifestyle toolkit integrates five behavioral domains: dietary guidance, structured physical activity, stress management, tobacco and alcohol cessation, and medication adherence. Delivery relies on trained frontline community health workers and a supporting digital health platform, with outcomes captured using point-of-care devices over a 24-month trial window. Notably, the protocol adopts a Type III effectiveness-implementation hybrid design, meaning it is powered to evaluate implementation fidelity and barriers alongside clinical outcomes.
This protocol paper, not a results paper, means no efficacy data are yet available — a critical caveat for readers seeking actionable evidence. The trial's value, if completed as designed, will lie in its implementation science contribution: understanding how culturally adapted, worker-delivered lifestyle programs perform at scale in rural South Asian primary care, where pharmacological multimorbidity management is often the default. The WHO-HEARTS framework underpinning the toolkit has global validation, but its translation into an Indian rural context with intergenerational preventive components is genuinely novel. The digital-plus-human delivery model also reflects a pragmatic hybrid worth watching as a scalable template for low- and middle-income country non-communicable disease programs. Overall, this is incremental-to-confirmatory until results emerge.