Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)
- Conditions
- Primary Prevention of Cardiovascular Diseases
- Interventions
- Behavioral: MYCardio-PEER
- Registration Number
- NCT06408493
- Lead Sponsor
- Monash University Malaysia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention MYCardio-PEER Participants will attend the 8-weeks MYCardio-PEER program with their peer leaders, supplemented with face-to-face components.
- Primary Outcome Measures
Name Time Method Framingham Risk Score for Cardiovascular Disease Risk 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 Outcome Measures
Name Time Method Body weight 20 weeks Body weight will be assessed in kilograms.
Low-density lipoprotein cholesterol (LDL-C) level 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.
High-density lipoprotein cholesterol (HDL-C) level 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.
Blood pressure 20 weeks The blood pressure will be measured in mmHg. Blood pressure more than 140/90 mmHg is considered high blood pressure.
Triglycerides level 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.
Fasting blood glucose level 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.
Total cholesterol level 20 weeks Total cholesterol will be measured in mmol/L. Total cholesterol more than 5.2 mmol/L is considered high.
Body height Baseline Body height will be assessed in meters.
Attitude and Beliefs about Cardiovascular Risk 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.
Dietary intakes 20 weeks The usual dietary intakes will be assessed using the short food frequency questionnaire. It provides details on daily intake of food groups.
Waist circumference 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.
Nutrient intakes 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.
Smoking habit 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?
Body mass index 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.
Medication Understanding and Taking Self-Efficacy 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.
Alcohol consumption 20 weeks Participants will be asked if they are non-drinker, past drinker or current drinker; how long (years) have you been consuming alcohol?
Physical activity level 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).
Stress level 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
Trial Locations
- Locations (1)
Monash University
🇲🇾Subang Jaya, Selangor, Malaysia