m-Lifestyle Intervention for Employees (m-LIfE): protocol for a pilot cluster randomized controlled trial on cardiovascular disease prevention strategies

INTRODUCTION: Cardiovascular diseases (CVDs) are the leading cause of mortality globally. Developing countries, including Pakistan, face a significant burden of CVD risk factors. Mobile health (mHealth) interventions have shown potential in promoting physical activity (PA) and reducing sedentary behavior; however, their use in CVD risk prevention, particularly among high-risk, urban sedentary employees remains underexplored. This study aims to develop and evaluate the feasibility and potential efficacy of a mobile-based Lifestyle Intervention for Employees (m-LIfE) to improve PA among sedentary bank employees in Karachi, Pakistan. METHODS AND ANALYSIS: A multiphase-sequential design will be conducted in two phases across branches of three commercial banks (one public and two private) in Karachi. In phase 1, a cross-sectional study will be conducted to estimate 10-year and lifetime risk for CVD events among bank employees, followed by focus groups discussions and interviews to explore employees' awareness, perceptions, and preferences regarding CVD prevention. These findings will inform the development of the m-LIfE app using a human-centered design (HCD) approach. In phase 2, a pilot cluster randomized controlled trial will be conducted to assess the feasibility (primary outcome) and potential efficacy of m-LIfE on PA (secondary outcome) over 12 weeks, with a 4-week post-intervention follow-up. Bank branches will serve as clusters, with four randomized to m-LIfE and four to routine care. The m-LIfE app will deliver healthy lifestyle content for behavior change, and routine-care participants will receive paper-based educational pamphlets on CVD prevention. DISCUSSION: m-LIfE will use an HCD approach to co-create the intervention with participants, ensuring contextual relevance and addressing barriers faced by sedentary employees. This approach complements global evidence while accounting for unique cultural, organizational, and individual factors shaping lifestyle behaviors in Pakistan. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov on 20th May 2025 (Identifier: NCT06981247).