Physical Activitym-LIfENCT06981247
Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan
A study testing m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. and Routine care arm in people with Physical Activity and Life Style, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Life Style, Dietary Habits
- What is being tested?
- m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. and Routine care arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 6 months of job experience in any bank
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Samina Akhtar, 00923314312920, samina.yousanaf@aku.edu
About this study
Official title: m-Lifestyle Intervention for Employees (m-LIfE): Protocol for a Pilot Cluster Randomized Controlled Trial on Cardiovascular Disease Prevention Strategies
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.
Read more
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.
Read the 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. 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.
- Conditions
- Physical Activity, Life Style, Dietary Habits, Cardiovascular Diseases
- Being tested
- m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet., Routine care arm
- Keywords
- Primary care, Cardiology, Preventive medicine, risk perception, cardiovascular health, CVD, Sedentary lifestyle, mHealth, Digital health, Feasibility
- Medical subject headings
- Motor Activity, Feeding Behavior, Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet.Behavioural
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.
Routine care armOther
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.
| Study group | Role | What they receive |
|---|---|---|
| m-LIfE | Experimental | 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. Receives: Behavioral: m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. |
| Routine care arm | Other | 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. Receives: Other: Routine care arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: Treatment fidelity will be measured at post-intervention (Week 12, immediately after the intervention ends)
Secondary outcomes (1)
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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start22 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Aysha Almas, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981247
- Sponsor's protocol ID
- ERC No. 2025-9680-29143
- Acronym
- m-LIfE
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37316940Akhtar S, Samad Z, Bloomfield GS, Ajani K, Virani SS, Awan S, Almas A. m-Lifestyle Intervention for Employees (m-LIfE): protocol for a pilot cluster randomized controlled trial on cardiovascular disease prevention strategies. Pilot Feasibility Stud. 2026 Apr 7;12(1):82. doi: 10.1186/s40814-026-01815-9.
PubMed 41947180
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- m-Lifestyle Intervention for Employees (m-LIfE): Protocol for a Pilot Cluster Randomized Controlled Trial on Cardiovascular Disease Prevention Strategies
- ClinicalTrials.gov ID
- NCT06981247
- Acronym / sponsor ID
- m-LIfE / ERC No. 2025-9680-29143
- Conditions
- Physical Activity, Life Style, Dietary Habits, Cardiovascular Diseases
- Keywords
- Primary care, Cardiology, Preventive medicine, risk perception, cardiovascular health, CVD, Sedentary lifestyle, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-LIfE | Experimental | Behavioral: m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet.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. |
| Routine care arm | Other | Other: Routine care armParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 6 months of job experience in any bank
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet.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. | Behavioural | m-LIfE |
| Routine care armParticipants 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. | Other | Routine care arm |
Primary outcome
Feasibility of m-LIfE application (Recruitment Rate)
Time frame: Recruitment rate will be measured at baseline.
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 (%)
Feasibility of m-LIfE application (Retention Rate)
Time frame: Retention rate will be measured at post-intervention (Week 12, immediately after the intervention ends)
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 (%)
Feasibility of m-LIfE application (Treatment Fidelity)
Time frame: Treatment fidelity will be measured at post-intervention (Week 12, immediately after the intervention ends)
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 (%)
1 secondary outcome
Potential efficacy of m-LIfE application (Physical activity)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 37316940Elahi 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.
- Derived from this study: PubMed 41947180Akhtar S, Samad Z, Bloomfield GS, Ajani K, Virani SS, Awan S, Almas A. m-Lifestyle Intervention for Employees (m-LIfE): protocol for a pilot cluster randomized controlled trial on cardiovascular disease prevention strategies. Pilot Feasibility Stud. 2026 Apr 7;12(1):82. doi: 10.1186/s40814-026-01815-9.
- This URL links to the World Health Organization website, which provides the latest facts about cardiovascular disease (CVD) and its risk factors.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aysha Almas, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. and Routine care arm in people with Physical Activity and Life Style, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samina Akhtar (+923314312920, samina.yousanaf@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of m-LIfE application (Recruitment Rate) (time frame: Recruitment rate will be measured at baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.