Clinical trial NCT06981247: Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan
Official title: m-Lifestyle Intervention for Employees (m-LIfE): Protocol for a Pilot Cluster Randomized Controlled Trial on Cardiovascular Disease Prevention Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Activity
Life Style
Dietary Habits
Cardiovascular Diseases
Keywords: Primary care
Cardiology
Preventive medicine
risk perception
cardiovascular health
CVD
Sedentary lifestyle
mHealth
Digital health
Feasibility
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2025-05-20
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heart diseases and other non-communicable diseases are serious health issues in countries like Pakistan. Many people who work in offices, like bank employees, sit for more than 8 hours a day. This is called a sedentary lifestyle, and it increases the risk of heart diseases.

This research project aims to find out if a newly developed context specific mobile phone application can help these sedentary employees to improve their lifestyle. The app, called m-LIfE (mHealth-based Lifestyle Intervention for Employees), will be designed to help employees to move more during the day and eat healthier food like fruits and vegetables.

The study will involve bank employees in urban Karachi, Pakistan. They will be divided into two arms:

Intervention arm: Participants in this arm will use the m-LIfE app for 12 weeks. They will get reminders and tips to take breaks, exercise, and eat healthy.

Routine care arm: Participants in this arm will receive printed basic educational material about prevention of risk factors of heart diseases and improving lifestyle.

After the 12 weeks of intervention, there will be a follow-up period at 4th week to check if participants are maintaining healthy habits.

This study could help find simple and affordable ways to improve the health of office workers and reduce pressure on the healthcare system.

Detailed description: 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.

The pilot cRCT will evaluate the feasibility and potential efficacy of the m-LIfE over a 12-week intervention period, with a 4-week follow-up. Eight clusters (bank branches) will be randomly selected out of 313 branches across Karachi, out of which four will be randomized to the m-LIfE intervention, and four clusters will serve as the routine care arm. The study will be conducted in branches of three commercial banks (one public and two private) located in urban Karachi, Pakistan.

Eligibility criteria: Inclusion Criteria:

• At least 6 months of job experience in any bank

Exclusion Criteria:

* Diagnosed case of myocardial infarction, stroke, coronary heart disease, cerebrovascular disease, or peripheral arterial diseases
* Pregnant women
* Individuals with acute illnesses that limit physical activity

Primary outcomes:
measure: Feasibility of m-LIfE application (Recruitment Rate)
timeFrame: Recruitment rate will be measured at baseline.
measure: Feasibility of m-LIfE application (Retention Rate)
timeFrame: Retention rate will be measured at post-intervention (Week 12, immediately after the intervention ends)
measure: Feasibility of m-LIfE application (Treatment Fidelity)
timeFrame: Treatment fidelity will be measured at post-intervention (Week 12, immediately after the intervention ends)
Secondary outcomes:
measure: Potential efficacy of m-LIfE application (Physical activity duration)
timeFrame: Data will be collected at three time points: baseline (Week 0), post-intervention (Week 12), and follow-up (Week 16, four weeks after the intervention ends).
measure: Potential efficacy of m-LIfE application (Physical activity frequency)
timeFrame: Data will be collected at three time points: baseline (Week 0), post-intervention (Week 12), and follow-up (Week 16, four weeks after the intervention ends).
measure: Potential efficacy of m-LIfE application (Physical activity intensity)
timeFrame: Data will be collected at three time points: baseline (Week 0), post-intervention (Week 12), and follow-up (Week 16, four weeks after the intervention ends).
measure: Potential efficacy of m-LIfE application (Fruits intake)
timeFrame: Data will be collected at three time points: baseline (Week 0), post-intervention (Week 12), and follow-up (Week 16, four weeks after the intervention ends).
measure: Potential efficacy of m-LIfE application (Vegetables intake)
timeFrame: Data will be collected at three time points: baseline (Week 0), post-intervention (Week 12), and follow-up (Week 16, four weeks after the intervention ends).
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Aysha Almas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elahi A, Ali AA, Khan AH, Samad Z, Shahab H, Aziz N, Almas A. Challenges of managing hypertension in Pakistan - a review. Clin Hypertens. 2023 Jun 15;29(1):17. doi: 10.1186/s40885-023-00245-6.