What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease that focus on behavioral modification, such as dietary changes, increased physical activity, and smoking cessation, generally have minimal side effects. Dietary changes may sometimes lead to gastrointestinal discomfort as the body adjusts to new foods. Increased physical activity can result in muscle soreness or injury if not done properly. Smoking cessation often leads to withdrawal symptoms like irritability, anxiety, and increased appetite. Overall, these side effects are typically mild and temporary compared to the significant benefits of reducing cardiovascular risk.

What prior FDA approvals exist?

The FDA has approved various treatments for cardiovascular disease that align with behavioral modification strategies, such as lifestyle interventions and pharmacotherapy. While specific FDA approvals for interactive multi-media health behavior interventions are not detailed, the general approach includes medications like statins for cholesterol management, antihypertensives for blood pressure control, and antiplatelet agents for preventing blood clots. These pharmacologic treatments are often complemented by behavioral strategies such as dietary changes, physical activity, smoking cessation, and patient education programs, which are integral to comprehensive cardiovascular disease management.

What other types of research exist?

Promising, novel alternatives for cardiovascular disease patients include: 1) Telehealth-based Cognitive Behavioral Therapy (CBT) for lifestyle changes, which has shown efficacy in improving health outcomes; 2) Mobile health (mHealth) applications that offer personalized feedback and real-time monitoring of health metrics; 3) Wearable technology integrated with AI to provide continuous health monitoring and personalized recommendations; 4) Genetic risk assessment tools combined with tailored lifestyle interventions to motivate behavior change; 5) Virtual reality (VR) programs for stress reduction and physical activity engagement.

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Multimedia Lifestyle Improvement for Cardiovascular Disease (SAHARA Trial)

N/A

Waitlist Available

Led By Sonia Anand, MD, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than or equal to 30 years of age

No previous cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months from randomization

Awards & highlights

Summary

This trial aims to help South Asians in Canada who are at higher risk for heart disease. Participants will use a digital program to set health goals and receive regular advice on improving their diet, exercise, and smoking habits. The goal is to see if this approach can reduce their heart disease risk.

Who is the study for?

The SAHARA-Trial is for South Asian individuals aged 30 or older living in Ontario or British Columbia, who have not had cardiovascular disease and are not currently pregnant. Participants must be able to use the internet, email, and multimedia devices.

What is being tested?

This trial tests a 12-month interactive multimedia program designed to improve smoking habits, diet, and physical activity against usual care. It also examines if knowing one's genetic risk for heart attack affects behavior change and cardiac risk factors.

What are the potential side effects?

Since this trial involves lifestyle improvements through an educational intervention rather than medication, side effects are minimal but may include the stress of lifestyle changes or discomfort from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or older.

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I have never had heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness of a 12 Month Culturally-Specific Multi-media Intervention on Heart Health Risk

Secondary study objectives

Change in Diabetes Status

Change in Hypertension Status

Myocardial Infarction

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Multimedia Lifestyle ImprovementActive Control1 Intervention

Includes goal setting, self monitoring and participants will receive regular health messaging using electronic media regarding smoking, dietary habits \& physical activity

Group II: Usual CarePlacebo Group1 Intervention

Includes usual advice and no regular health messaging.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions for cardiovascular disease (CVD) focus on modifying lifestyle factors such as smoking, diet, and physical activity through goal setting, health messaging, and feedback. These mechanisms work by encouraging patients to set specific, achievable health goals, providing continuous health education and reminders, and offering feedback to reinforce positive changes. This approach helps patients adopt and maintain healthier behaviors, thereby reducing risk factors like hypertension, high cholesterol, and obesity, which are pivotal in the progression of CVD.