Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)

November 27, 2025 updated by: Monash University Malaysia

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Selangor
      • Subang Jaya, Selangor, Malaysia, 47500
        • Monash University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

  • 0-13 = low stress
  • 14-26 = moderate stress
  • 27-40 = high 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amutha Ramadas, PhD, Monash University Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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