Rationale, design, analysis plan and baseline characteristics of a cluster randomized controlled trial for management of salt intake and salt procurement in hypertensive individuals and households in rural Central India through a Community Health Worker delivered Behavior Change Communication Intervention

Background Cardiovascular diseases (CVD) contribute to highest number of non-communicable diseases associated morbidity and mortality. Uncontrolled hypertension has been linked to development and progression of CVDs. The global age-standardized prevalence of hypertension in 30-79 years age group is 32% for women and 34% for men. Hypertension is a metabolic risk factor that is drastically affected by dietary salt. Excessive dietary salt consumption is a behavioral risk factor and has been a WHO global target for hypertension and CVD management. The per capita global and national dietary salt consumption estimates exceed the recommended cut-off of 5g/day. Apart from policy changes, dietary salt consumption reduction through health promotion activities has been mandated by WHO and initiated in many countries. Community health workers (CHWs) have been identified as a target cadre for successful implementation of health promotion interventions. We aim to ascertain the effectiveness of various counseling modes on relative reduction of per capita dietary salt intake and household salt procurement. Methods An open label, factorial, cluster-RCT was executed in rural central India. Intervention arms were individual, group and mixed (group followed by individual) counseling and one standard care arm. Results A total of 127 adult hypertensive individuals were recruited in the study. One CHW was considered as one cluster and a total of eight (8) clusters were randomized for the study. The baseline characteristics of the participants have been presented. Conclusion The results of this trial will inform up on effectiveness of different modes of behavior change communication intervention on reducing dietary salt-intake and procurement.