Vitalizing Community against Non-communicable diseases (V-CaN): Protocol of a hybrid type II effectiveness/ implementation cluster field trial for health promotion against Non-communicable diseases risk factors in rural India (Preprint)

BACKGROUND Low-and-Middle income countries are facing the emerging burden of chronic non-communicable diseases (NCDs). Apart from high costs to the health system, NCDs also afflict high out of pocket expenditure. The risk factors for NCDs are initiated at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. OBJECTIVE To develop, implement and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanism of Village Health Nutrition and Sanitation Committees (VHNSCs), Women’s Self-help Groups (SHGs) and Schools on modifiable risk factors for NCDs among young people (10-30 years). METHODS The proposed type II hybrid effectiveness/ implementation cluster randomized field trial will be conducted in the catchment area of four Primary Health Centers (PHCs) in Wardha district of India each representing one arm of the study. Each of the four PHCs will be randomly allocated to one of the three intervention arms or to the control arm. The primary strategy under the study would be health promotion by creating change agents which would be different for each of the intervention arms viz. VHNSC members, SHG members, or school students. The study will be implemented in 3 phases from January 2022-December 2024. First, the preparatory phase for baseline assessment of practices related to modifiable risk factors of NCDs and participatory development of the health promotion modules. Second, the implementation phase for implementing the participatory health promotion initiative based on appropriate behavior change models. This will also include concurrent monitoring of implementation, organization of community-based events and preparation of a sustainability and exit plan towards the end of this phase. Third, assessment/ evaluation phase for studying the effectiveness of each of the intervention in reduction of risk factor prevalence at the population level. RESULTS From each arm, 3000 randomly selected individuals will be assessed for behavioral risk factors and 400 (randomly selected subset from the 3000) will be assessed for biochemical risk factors during baseline as well endline assessments (total 12000 for behavioral and 1600 for biochemical risk factors). Difference in difference, ANOVA/MANCOVA, and regression analysis will be used to find out the effectiveness of all the interventions. Qualitative methods like FGDs and stories of change will be documented and analyzed using thematic content analysis. The implementation outcomes will be reported using the PRISM RE-AIM framework. CONCLUSIONS The study will help to find the magnitude of risk factors for NCDs, its determinants, feasibility and effectiveness of a community-based trial for its prevention. The findings will help to develop a community-based health promotion model for prevention of NCDs through the life cycle approach. Thus, the proposed research has every chance of leading directly to improvements in population health. CLINICALTRIAL The study has been registered with the Clinical Trials Registration India (CTRI) prospectively on 28/10/2020. The registry number: CTRI/2020/10/028700