Cardiovascular Disease Prevention Strategies for High-risk Urban Sedentary Employees in Karachi, Pakistan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorAga Khan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
m-LIfE: mobile based lifestyle intervention for employees to increase their physical activity and promote healthy diet.
BehavioralThe 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 arm
Other interventionParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: m-LIfEExperimental treatment 1 intervention
Group B: Routine care armOther 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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)3
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)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
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).Other outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Source ClinicalTrials.gov