Reducing cardiovascular risk through Community Action for Lifestyle Modification (CALM) in a high-burden non-communicable disease setting: A type 3 Hybrid Effectiveness -Implementation study

Much is known about the benefits of lifestyle change for prevention of chronic disease, but there is an evidence-action gap in implementation and scale up to achieve population goals. Health care workers encounter operational difficulties such as excessive workloads, time limitations, inadequate decision-making tools, and poor assistance for community mobilization initiatives. Our goal is to assess the adaptation and implementation of community lifestyle clinics in primary care setting of Puducherry using a type 3 Hybrid Effectiveness -Implementation study with a stepped wedge cluster randomised design.

Initially a stakeholder workshop will be organised to adapt the ongoing lifestyle intervention. We will randomise 2400 participants from eight PHCs in a stepped wedge fashion across five time periods. The intervention entails app-based risk stratification and personalized counseling by lifestyle counselors and HCWs at community lifestyle clinics. Other components include patient risk tracking charts, motivational interviewing, community mobilization using self-help group-based programs and community events. Endline assessment after two years of intervention will include anthropometry and blood investigations. Mixed methods approach will be employed to gather data at the system, organizational and individual level using interview guides and observation checklists.

Data management will be done using REDCap. Data analysis will be done using Generalized linear mixed models on STATA 17 and NVivo software. This intervention will be guided by the CFIR 2.0 and reported using STaRI and CONSORT guidelines. Implementation outcomes will be based on the five dimensions of the RE AIM framework. Data from observation checklists and review of medical records will be analyzed using frequencies, percentages, mean and median. Generalized linear mixed models (binomial distribution, logit link) with random effects for PHCs will be used to compare the effect of the intervention with routine practice. This model will incorporate independent variables (fixed effects), consider the general time trend, and allow for the intervention effect to grow over time.

This project will develop need-based tools and simplified workflows for effective counselling by Health care workers. The research will generate evidence on the effectiveness of community lifestyle clinics in terms of individual and community engagement in LSM and offer valuable insights into how best to implement evidence-based practices that address cardiovascular risk reduction in primary care. This implementation research will demonstrate scalability by extending CALM intervention beyond the developing institution to primary care settings after adapting it to the end users and workflows in the health system and community and help identify contextual factors to inform strategies for large-scale dissemination.