Clinical trial NCT06408493: Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)
Official title: Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Prevention of Cardiovascular Diseases
Keywords: Peer-led
Primary prevention
Cardiovascular diseases
Digital health
Lifestyle intervention
Peer support
Community
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education, Malaysia
First posted: 2024-05-10
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Framingham Risk Score for Cardiovascular Disease Risk
timeFrame: 20 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 20 weeks
measure: Total cholesterol level
timeFrame: 20 weeks
measure: High-density lipoprotein cholesterol (HDL-C) level
timeFrame: 20 weeks
measure: Low-density lipoprotein cholesterol (LDL-C) level
timeFrame: 20 weeks
measure: Triglycerides level
timeFrame: 20 weeks
measure: Fasting blood glucose level
timeFrame: 20 weeks
measure: Body weight
timeFrame: 20 weeks
measure: Body height
timeFrame: Baseline
measure: Body mass index
timeFrame: 20 weeks
measure: Waist circumference
timeFrame: 20 weeks
measure: Attitude and Beliefs about Cardiovascular Risk
timeFrame: 20 weeks
measure: Physical activity level
timeFrame: 20 weeks
measure: Medication Understanding and Taking Self-Efficacy
timeFrame: 20 weeks
measure: Dietary intakes
timeFrame: 20 weeks
measure: Nutrient intakes
timeFrame: 20 weeks
measure: Stress level
timeFrame: 20 weeks
measure: Smoking habit
timeFrame: 20 weeks
measure: Alcohol consumption
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Monash University
state: Selangor
Study officials:
affiliation: Monash University Malaysia
name: Amutha Ramadas, PhD
role: PRINCIPAL_INVESTIGATOR
References: