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Primary Prevention of Cardiovascular DiseasesNCT06408493

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

A study testing MYCardio-PEER in people with Primary Prevention of Cardiovascular Diseases, run by Monash University Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 74 years
What is being tested?
MYCardio-PEER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteMalaysia
Study dates
1 Mar 2024to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 30 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Monash University

    Subang Jaya, Selangor, 47500

Other trials in Malaysia

About this study

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:

Read more
  • 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.

Being tested
MYCardio-PEER
Keywords
Peer-led, Primary prevention, Cardiovascular diseases, Digital health, Lifestyle intervention, Peer support, Community
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYCardio-PEERBehavioural

    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.

Study groups in NCT06408493
Study groupRoleWhat they receive
InterventionExperimentalParticipants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components.
Receives: Behavioral: MYCardio-PEER
ControlNo interventionParticipants will receive printed documents with standard tips on dietary and lifestyle management for CVD.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Framingham Risk Score for Cardiovascular Disease Risk

    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.

    Measured: 20 weeks

Secondary outcomes (18)

  1. Blood pressure

    The blood pressure will be measured in mmHg. Blood pressure more than 140/90 mmHg is considered high blood pressure.

    Measured: 20 weeks

  2. Total cholesterol level

    Total cholesterol will be measured in mmol/L. Total cholesterol more than 5.2 mmol/L is considered high.

    Measured: 20 weeks

  3. High-density lipoprotein cholesterol (HDL-C) level

    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.

    Measured: 20 weeks

  4. Low-density lipoprotein cholesterol (LDL-C) level

    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.

    Measured: 20 weeks

  5. Triglycerides level

    Triglycerides level will be measured in mmol/L. The healthy cut-off point of triglycerides level is less than 1.7 mmol/L.

    Measured: 20 weeks

  6. Fasting blood glucose level

    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.

    Measured: 20 weeks

  7. Body weight

    Body weight will be assessed in kilograms.

    Measured: 20 weeks

  8. Body height

    Body height will be assessed in meters.

    Measured: Baseline

  9. Body mass index

    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.

    Measured: 20 weeks

  10. Waist circumference

    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.

    Measured: 20 weeks

  11. Attitude and Beliefs about Cardiovascular Risk

    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.

    Measured: 20 weeks

  12. Physical activity level

    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).

    Measured: 20 weeks

  13. Medication Understanding and Taking Self-Efficacy

    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.

    Measured: 20 weeks

  14. Dietary intakes

    The usual dietary intakes will be assessed using the short food frequency questionnaire. It provides details on daily intake of food groups.

    Measured: 20 weeks

  15. Nutrient intakes

    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.

    Measured: 20 weeks

  16. Stress level

    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

    Measured: 20 weeks

  17. Smoking habit

    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?

    Measured: 20 weeks

  18. Alcohol consumption

    Participants will be asked if they are non-drinker, past drinker or current drinker; how long (years) have you been consuming alcohol?

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start1 Mar 2024
  3. Primary completion30 Oct 2024
  4. Study completion31 Dec 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06408493
Sponsor's protocol ID
36440
Status last verified
Nov 2025
First submitted
18 Mar 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lim GP, Appalasamy JR, Ahmad B, Quek KF, Ramadas A. Cardiovascular risk reduction through a peer-led digital health lifestyle intervention in a low-income community: outcomes from the MYCardio-PEER program. Nutr Metab Cardiovasc Dis. 2026 Sep;36(9):104723. doi: 10.1016/j.numecd.2026.104723. Epub 2026 Apr 5.

    PubMed 42002507

  • 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.

    PubMed 41222971

  • 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.

    PubMed 40025749

Questions about this trial

What is this clinical trial studying?

A study testing MYCardio-PEER in people with Primary Prevention of Cardiovascular Diseases, run by Monash University Malaysia at 1 site in Malaysia.

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 6 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: finished, as of the sponsor's last update on 5 Dec 2025. 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 Malaysia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Framingham Risk Score for Cardiovascular Disease Risk (time frame: 20 weeks). 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 NCT06408493, which also lists 3 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 5 Dec 2025.

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