Monash University
Subang Jaya, Selangor, 47500, Malaysia
NCT Number: NCT06408493
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.
Looking for future studies?
Notify Me30 year–74 year
All sexes
Interventional
Not applicable
Subang Jaya, Selangor, 47500, Malaysia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 20 weeks
The blood pressure will be measured in mmHg. Blood pressure more than 140/90 mmHg is considered high blood pressure.
Time frame: 20 weeks
Total cholesterol will be measured in mmol/L. Total cholesterol more than 5.2 mmol/L is considered high.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 weeks
Body weight will be assessed in kilograms.
Time frame: Baseline
Body height will be assessed in meters.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 20 weeks
The usual dietary intakes will be assessed using the short food frequency questionnaire. It provides details on daily intake of food groups.
Time frame: 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.
Time frame: 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.
Time frame: 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?
Time frame: 20 weeks
Participants will be asked if they are non-drinker, past drinker or current drinker; how long (years) have you been consuming alcohol?
Monash University Malaysia
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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