An interventional study of m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. and Routine care arm in Physical Activity, Life Style and Dietary Habits, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
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.
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. Ten clusters (bank branches) will be randomly selected out of 313 branches across Karachi, out of which five will be randomized to the m-LIfE intervention, and five clusters will serve as the routine care arm. The study will be conducted in branches of two commercial private banks located in urban Karachi, Pakistan.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 84 is close to the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
Compared within Feeding Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the intervention arm will receive mHealth application (m-LIfE). The application will be installed on participants' personal mobile phones, and each participant will be provided with a unique user ID and password.
Behavioral: m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet.
Participants in the routine care arm will receive basic educational material in the form of paper-based pamphlets without any active intervention by the study team.
Other: Routine care arm
The m-LIfE will primarily deliver healthy lifestyle educational content, provide customized strategies for PA, and offer participants the option to enter their daily intake of fruits and vegetables through Food Log feature. m-LIfE will track PA and diet, send tailored reminders, and provide motivational messages. Participants will receive two text messages daily: a goal reminder in the morning and feedback or reflection on their progress in the evening. Additionally, they will receive one motivational message at the end of each week to sustain their motivation. Personalized feedback will also be provided through the application, featuring graphs to illustrate daily, weekly, and monthly progress. To support participants further, the application will enable two-way communication, allowing users to seek assistance and ask questions from the research team. A dedicated contact number will be made available within the app to facilitate direct communication.
Participants in the routine care arm will receive educational material in the form of paper-based pamphlets to ensure they still benefit from basic health information on CVD risk prevention. They will continue their usual work routines without access to the app, but their PA and dietary habits will be assessed at baseline, post-intervention and at follow-up for comparative purposes.
Feasibility of m-LIfE application (Recruitment Rate)
Recruitment rate will be measured as the percentage of participants enrolled out of the total number of eligible participants invited to receive m-LIfE intervention. The trial will be considered feasible if recruitment rate exceeds 70%. Units of Measure: Percentage (%)
Time frame: Recruitment rate will be measured at baseline.
Feasibility of m-LIfE application (Retention Rate)
Retention rate will be measured as the percentage of participants who complete the post-intervention assessment at 12 weeks, out of those who were initially enrolled. The intervention will be considered feasible if the retention rate exceeds 70%. Units of Measure: Percentage (%)
Time frame: Retention rate will be measured at post-intervention (Week 12, immediately after the intervention ends)
Feasibility of m-LIfE application (Treatment Fidelity)
The treatment fidelity rate will be measured as the percentage of planned health-promoting sessions successfully delivered during the 12-week intervention period. The intervention will be considered feasible if the treatment fidelity rate exceeds 70%. Units of Measure: Percentage (%)
Time frame: Treatment fidelity will be measured at post-intervention (Week 12, immediately after the intervention ends)
Potential efficacy of m-LIfE application (Physical activity)
The duration of physical activity will be measured as the mean change in the daily step count. Unit of Measure: Step count
Time frame: 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).
Change in waist circumference
It will be measured as the mean change in the waist circumference. Unit of Measure: Centimeters (cm)
Time frame: 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).
Change in body mass index
It will be measured as the mean change in the body mass index. Unit of Measure: kilograms per meter squared (kg/m²)
Time frame: 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).
Changes in vegetable intake
It will be measured as the mean change in the number of servings of vegetables consumed per week by participants. Unit of Measure: Servings per week
Time frame: 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).
Changes in fruits intake
It will be measured as the mean change in the number of servings of fruits consumed per week by participants. Unit of Measure: Servings per week
Time frame: 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).
Change in diastolic blood pressure
It will be measured as the mean change in the Diastolic blood pressure reading. Unit of Measure: Millimeters of mercury (mmHg)
Time frame: 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).
Change in systolic blood pressure
It will be measured as the mean change in the systolic blood pressure reading. Unit of Measure: Millimeters of mercury (mmHg)
Time frame: 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).
Plan to share: Yes — We plan to share deidentified IPD with other researchers. The shared data will include deidentified participant behavioral risk factors, and other relevant variables collected during the study. Access to the data will be granted upon reasonable request. A data-sharing agreement that outlines the intended use of the data will be signed. Researchers requesting the data will need to adhere to ethical guidelines and data protection policies.
Supporting information: Study protocol
Time frame: Soon after the publication of trial with no end date
Access criteria: Researchers will need to submit a formal request to the PI, explaining the purpose of their request and how they plan to use the data. Access will be granted primarily for the purpose of verifying the results presented in the study. Any secondary analyses or additional studies using the IPD will require explicit permission from the PI.
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