NCT06408493

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

March 18, 2024

Last Update Submit

November 27, 2025

Conditions

Keywords

Peer-ledPrimary preventionCardiovascular diseasesDigital healthLifestyle interventionPeer supportCommunity

Outcome Measures

Primary Outcomes (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.

    20 weeks

Secondary Outcomes (18)

  • Blood pressure

    20 weeks

  • Total cholesterol level

    20 weeks

  • High-density lipoprotein cholesterol (HDL-C) level

    20 weeks

  • Low-density lipoprotein cholesterol (LDL-C) level

    20 weeks

  • Triglycerides level

    20 weeks

  • +13 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components.

Behavioral: MYCardio-PEER

Control

NO INTERVENTION

Participants will receive printed documents with standard tips on dietary and lifestyle management for CVD.

Interventions

MYCardio-PEERBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age30 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University

Subang Jaya, Selangor, 47500, Malaysia

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Amutha Ramadas, PhD

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

May 10, 2024

Study Start

March 1, 2024

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations