m-Lifestyle Intervention for Employees (m-LIfE): Protocol for a Pilot Cluster Randomized Controlled Trial on Cardiovascular Disease Prevention Strategies

Cardiovascular diseases (CVD) are the leading cause of mortality globally, with developing countries bearing a disproportionate burden of associated risk factors. Alarmingly, the age of onset of CVD is decreasing in these settings. Despite the significant burden, preventive strategies targeting modifiable risk factors often receive insufficient attention. Pakistan, as the fifth most populous country in the world and a low and middle-income country (LMIC) with a fragile healthcare system, relies heavily on out-of-pocket payments for healthcare (73% of the population). In this context, addressing CVD risk factors at the population level and targeting high-risk populations becomes an essential strategy for combating CVD.

The banking sector in particular has been facing a tremendous change for several years due to the increasing number of new entrants, which has increased competition among the banks. Economic uncertainties and political instability have also affected the industry and consequently the health outcomes of its employees who are considered high risk urban sedentary workers as they spend more than 8 hours of their daytime sitting with minimal physical activity (PA) and consuming high lipid diet. This behavior predisposes them to CVD unless they take preventive health behaviors (engage in regular PA, increase fruit and vegetable intake, and reduce fatty meals, sugar, and salt intake). Lifestyle modification aimed at improving PA and dietary habits is the first-line approach to reducing cardiovascular risk. However, the feasibility of implementing such strategies in urban environments needs to be examined. Currently, little is known about which intervention components would be most effective in improving the lifestyle behaviors of bank employees.

Pertinently, the workspaces of most bank branches in Pakistan lack suitable areas for relaxation or PA, further exacerbating the sedentary nature of their work. Consequently, this high-risk group requires targeted efforts to increase their knowledge and address their lifestyle behaviors for effective CVD prevention. Therefore, the development and testing of strategies specifically tailored to this occupational group are of utmost importance.

The overall aim of this research project is to develop and assess the feasibility of m-LIfE (mHealth-based Lifestyle Intervention for Employees) to improve lifestyle in high-risk urban sedentary employees (bank employees) from Karachi, Pakistan. The specific objectives are (1) To explore awareness (perception and preferences) about CVD and its prevention among high-risk sedentary employees, and design m-LIfE (2) To assess feasibility of m-LIfE versus routine care among high-risk sedentary employees. The secondary objective is to report potential efficacy on lifestyle (PA and dietary intake) in both m-LIfE and routine arm.

This study will employ a mixed-methods approach, beginning with an exploratory qualitative phase and followed by a pilot cluster randomized controlled trial (cRCT). The qualitative component will explore awareness, perceptions, and preferences regarding CVD and its prevention. Following this, m-LIfE app will be developed using human centered design approach.