Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Primary Prevention of Cardiovascular Diseases
- Sponsor
- Monash University Malaysia
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Framingham Risk Score for Cardiovascular Disease Risk
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Body weight(20 weeks)
- Low-density lipoprotein cholesterol (LDL-C) level(20 weeks)
- High-density lipoprotein cholesterol (HDL-C) level(20 weeks)
- Blood pressure(20 weeks)
- Triglycerides level(20 weeks)
- Fasting blood glucose level(20 weeks)
- Total cholesterol level(20 weeks)
- Body height(Baseline)
- Attitude and Beliefs about Cardiovascular Risk(20 weeks)
- Dietary intakes(20 weeks)
- Waist circumference(20 weeks)
- Nutrient intakes(20 weeks)
- Smoking habit(20 weeks)
- Body mass index(20 weeks)
- Medication Understanding and Taking Self-Efficacy(20 weeks)
- Alcohol consumption(20 weeks)
- Physical activity level(20 weeks)
- Stress level(20 weeks)