Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)

Primary Prevention of Cardiovascular Diseases Clinical Trial

Official title:

Peer-led Digital Health Lifestyle Intervention for a Low Income Community at Risk for Cardiovascular Diseases (MYCardio-PEER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06408493
• Other study ID #: 36440
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Monash University Malaysia
• Contact: Lim Geok Pei, MSc
• Phone: +60163938743
• Email: geok.lim[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Prevention of Cardiovascular Diseases

Intervention

Behavioral:
• MYCardio-PEER
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.

Locations

Country	Name	City	State
Malaysia	Monash University	Subang Jaya	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Monash University Malaysia	Ministry of Higher Education, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure	The blood pressure will be measured in mmHg. Blood pressure more than 140/90 mmHg is considered high blood pressure.	20 weeks
Secondary	Total cholesterol level	Total cholesterol will be measured in mmol/L. Total cholesterol more than 5.2 mmol/L is considered high.	20 weeks
Secondary	High-density lipoprotein cholesterol (HDL-C) level	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.	20 weeks
Secondary	Low-density lipoprotein cholesterol (LDL-C) level	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.	20 weeks
Secondary	Triglycerides level	Triglycerides level will be measured in mmol/L. The healthy cut-off point of triglycerides level is less than 1.7 mmol/L.	20 weeks
Secondary	Fasting blood glucose level	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.	20 weeks
Secondary	Body weight	Body weight will be assessed in kilograms.	20 weeks
Secondary	Body height	Body height will be assessed in meters.	Baseline
Secondary	Body mass index	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.	20 weeks
Secondary	Waist circumference	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.	20 weeks
Secondary	Attitude and Beliefs about Cardiovascular Risk	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.	20 weeks
Secondary	Physical activity level	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).	20 weeks
Secondary	Medication Understanding and Taking Self-Efficacy	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.	20 weeks
Secondary	Dietary intakes	The usual dietary intakes will be assessed using the short food frequency questionnaire. It provides details on daily intake of food groups.	20 weeks
Secondary	Nutrient intakes	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.	20 weeks
Secondary	Stress level	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	20 weeks
Secondary	Smoking habit	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?	20 weeks
Secondary	Alcohol consumption	Participants will be asked if they are non-drinker, past drinker or current drinker; how long (years) have you been consuming alcohol?	20 weeks