Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan

NCT06981247 | Not Yet Recruiting

• 2 other identifiers: ERC No. 2025-9680-291435D43TW011625
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 (%)

  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 (%)

  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 (%)

  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)

  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 (6)

• Change in waist circumference

  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

  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

  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).

Study Arms (2)

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.

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.

Other: Routine care arm

Interventions

m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet. BEHAVIORAL

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.

m-LIfE

Routine care arm OTHER

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.

Routine care arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months of job experience in any bank

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 37316940 BACKGROUND

Related Links

• This URL links to the World Health Organization website, which provides the latest facts about cardiovascular disease (CVD) and its risk factors.

MeSH Terms

Conditions

Motor Activity; Feeding Behavior; Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Aysha Almas, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samina Akhtar

CONTACT

+923314312920; samina.yousanaf@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

PA (1)