- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408493
Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)
The goal of this interventional study is to develop and assess the effectiveness of a peer-led digital health program (MYCardio-PEER) for primary prevention of cardiovascular disease (CVD) in a low-income community at-risk of CVD.
The main questions it aims to answer are:
- Is MYCardio-PEER effective in improving knowledge, lifestyle behaviors and CVD biomarkers of a low-income community at-risk for CVD?
- Is there an association between MYCardio-PEER participants' adherence and satisfaction, with effectiveness and sustainability of the program?
Participants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components. Participants will then be followed up for another 12 weeks, during which peer leaders and researchers will have minimal contact with the participants. Participants who have been allocated into the control group will receive printed documents with standard tips on dietary and lifestyle management for CVD, where they will be encouraged to maintain regular calorie intake and expenditure and perform regular exercise.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Subang Jaya, Selangor, Malaysia, 47500
- Monash University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mentally sound man/woman of at least 30 years old
- Monthly household income of less than RM3,710 or receiving government aid for low-income community
- Literate with a fair command of the Malay language
- Have mobile device connected to the Internet
- Willing to attend 8 weeks of intervention and be followed up for another 12 weeks during the maintenance phase.
- Have been confirmed to have a moderate or high risk for CVD based on the Framingham General CVD Risk Score
Exclusion Criteria:
- Pregnant, lactating or intend to become pregnant during the study period.
- Any other pre-existing conditions or severe complications that could compromise the ability to adhere to the study program.
- Enrolled in other studies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components.
|
MYCardio-PEER participants will attend an 8-weeks intervention program delivered over the social networking application.
Bite-sized videos and infographic posters on healthy diet and lifestyle for primary prevention of CVD will be delivered weekly, supplemented by interactive peer-group activities to encourage behavior change.
|
|
No Intervention: Control
Participants will receive printed documents with standard tips on dietary and lifestyle management for CVD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Framingham Risk Score for Cardiovascular Disease Risk
Time Frame: 20 weeks
|
The score is based on a person's age, sex, blood pressure, cholesterol levels, smoking status, and diabetes status.
The calculated score will be converted into 10-year risk percentage whereby the higher the percentage means higher cardiovascular disease risk.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 20 weeks
|
The blood pressure will be measured in mmHg.
Blood pressure more than 140/90 mmHg is considered high blood pressure.
|
20 weeks
|
|
Total cholesterol level
Time Frame: 20 weeks
|
Total cholesterol will be measured in mmol/L.
Total cholesterol more than 5.2 mmol/L is considered high.
|
20 weeks
|
|
High-density lipoprotein cholesterol (HDL-C) level
Time Frame: 20 weeks
|
High-density lipoprotein cholesterol (HDL-C) will be measured in mmol/L.
The healthy cut-off points of HDL-C in male is more than 1.0 mmol/L and in female more than 1.3 mmol/L.
|
20 weeks
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Time Frame: 20 weeks
|
Low-density lipoprotein cholesterol (LDL-C) will be measured in mmol/L.
The healthy cut-off point of LDL-C is less than 2.6 mmol/L.
|
20 weeks
|
|
Triglycerides level
Time Frame: 20 weeks
|
Triglycerides level will be measured in mmol/L.
The healthy cut-off point of triglycerides level is less than 1.7 mmol/L.
|
20 weeks
|
|
Fasting blood glucose level
Time Frame: 20 weeks
|
Fasting blood glucose level will be measured in mmol/L.
The healthy cut-off point of fasting blood glucose level is less than 6.1 mmol/L.
|
20 weeks
|
|
Body weight
Time Frame: 20 weeks
|
Body weight will be assessed in kilograms.
|
20 weeks
|
|
Body height
Time Frame: Baseline
|
Body height will be assessed in meters.
|
Baseline
|
|
Body mass index
Time Frame: 20 weeks
|
Body mass index (BMI) is derived from body weight in kilograms (kg) and body height in meters (m).
BMI is expressed as kg/m^2.
|
20 weeks
|
|
Waist circumference
Time Frame: 20 weeks
|
Waist circumference will be assessed in centimeters (cm).
The healthy cut-off point of waist circumference for male is less than or equal to 90cm and for female less than or equal to 80cm.
|
20 weeks
|
|
Attitude and Beliefs about Cardiovascular Risk
Time Frame: 20 weeks
|
Attitude and Beliefs about Cardiovascular Risk will be assessed using the Attitude and Beliefs about Cardiovascular Risk - Malay questionnaire.
The overall score was calculated from all item scores by the domains.
The higher the score, the higher the awareness and the readiness to change the behavior.
|
20 weeks
|
|
Physical activity level
Time Frame: 20 weeks
|
The physical activity level will be assessed using the International Physical Activity Questionnaire.
The intensity of self-reported physical activity lasting at least 10 minutes per bout was measured in metabolic equivalent (MET).
The accumulated MET-minutes per week will be calculated to categorize into low, moderate (at least 600 MET-minutes per week) or high physical activity level (at least 3000 MET-minutes per week).
|
20 weeks
|
|
Medication Understanding and Taking Self-Efficacy
Time Frame: 20 weeks
|
The Medication Understanding and Taking Self-Efficacy will be assessed using the Medication Understanding and Taking Self-Efficacy scale.
The scores ranged from 8 to 32, with higher scores indicating greater levels of medication understanding.
|
20 weeks
|
|
Dietary intakes
Time Frame: 20 weeks
|
The usual dietary intakes will be assessed using the short food frequency questionnaire.
It provides details on daily intake of food groups.
|
20 weeks
|
|
Nutrient intakes
Time Frame: 20 weeks
|
Nutrient intakes will be assessed using the 2-day 24-hour diet recalls.
The participants will be asked about all details of the foods and beverages consumed in the past 24 hours, including the types of food, cooking methods, estimated portion size and brands.
Nutrient intakes from 24-hour dietary recalls will be analyzed with Nutritionist Pro software (Axxya Systems, USA) to yield total energy, macronutrient and micronutrient intakes.
|
20 weeks
|
|
Stress level
Time Frame: 20 weeks
|
The stress level will be assessed using the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
20 weeks
|
|
Smoking habit
Time Frame: 20 weeks
|
Participants will be asked if they are non-smoker, past smoker or current smoker; how long have you been smoking; and how many cigarettes did/do you smoke per day?
|
20 weeks
|
|
Alcohol consumption
Time Frame: 20 weeks
|
Participants will be asked if they are non-drinker, past drinker or current drinker; how long (years) have you been consuming alcohol?
|
20 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amutha Ramadas, PhD, Monash University Malaysia
Publications and helpful links
General Publications
- Lim GP, Appalasamy JR, Ahmad B, Quek KF, Ramadas A. Peer-Led Digital Health Lifestyle Intervention in a Low-Income Community at Risk for Cardiovascular Disease (MYCardio-PEER): Mixed Methods Development and Process Evaluation Study. J Med Internet Res. 2025 Nov 12;27:e77063. doi: 10.2196/77063.
- Lim GP, Appalasamy JR, Ahmad B, Quek KF, Shaharuddin S, Ramadas A. Peer-led digital health lifestyle intervention for a low-income community at risk for cardiovascular diseases (MYCardio-PEER): a quasi-experimental study protocol. Prim Health Care Res Dev. 2025 Mar 3;26:e20. doi: 10.1017/S1463423625000192.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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