BASIC-S Intervention for Cardiovascular Risk

(BASIC-S Trial)

AJ
AA
Overseen ByAbolfazl Avan, MD, PhD.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a lifestyle program called BASIC-S can help reduce the risk of stroke, heart disease, and dementia by encouraging gradual changes in daily habits. The program focuses on improving blood pressure, physical activity, sleep, social interactions, and nutrition, supported by motivational coaching, video check-ins, texts, and a digital workbook. Participants will either receive the BASIC-S program or continue with their usual care for comparison. Individuals who work at or recently retired from London Health Sciences Centre or Western University and can engage in light-to-moderate exercise might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to healthier lifestyle strategies.

What prior data suggests that the BASIC-S protocol is safe for participants?

A previous study showed that lifestyle changes focused on behavior are safe and well-received by participants. The BASIC-S Intervention includes motivational coaching, secure video check-ins, automated text messages, and a digital workbook to help people gradually change their lifestyles. Since this approach doesn't use medication or involve medical procedures, the risk of negative effects remains generally low. Participants in similar programs reported few side effects, mostly related to the time commitment or adjusting to new habits. Therefore, people considering joining this trial can expect the BASIC-S Intervention to be a safe option that supports healthy lifestyle changes.12345

Why are researchers excited about this trial?

Researchers are excited about the BASIC-S Intervention for cardiovascular risk because it uses a multicomponent behavioral lifestyle program based on the Information-Motivation-Behavioral Skills (IMB) model. Unlike standard care, which typically focuses on medication and routine healthcare, this intervention aims to empower individuals by enhancing their knowledge, motivation, and skills to make healthier lifestyle choices. This approach is unique because it targets behavior change directly, which could lead to more sustainable long-term improvements in cardiovascular health. The personalized and comprehensive nature of the intervention holds the promise of addressing root causes of cardiovascular issues, potentially reducing risk more effectively than conventional methods.

What evidence suggests that the BASIC-S Intervention is effective for cardiovascular risk?

Research has shown that community programs like the BASIC-S program, which participants in this trial may receive, can improve heart health. Studies have found that these programs increase knowledge about heart disease and promote healthier habits, such as better eating and more exercise. One study found that efforts to lower blood pressure reduced the risk of dying from heart disease by 21%. Another study showed a small but positive decrease in the risk of heart problems over ten years. These findings suggest that programs like BASIC-S, which focus on lifestyle changes, can help prevent heart-related issues.678910

Are You a Good Fit for This Trial?

This trial is for adults 18+ who work at or recently retired from LHSC or Western University, especially those over 50. Participants need to be able to use a smartphone, do light exercise, and understand English. People with unstable heart problems, severe memory issues, or recent serious psychiatric events can't join.

Inclusion Criteria

Access to a mobile device capable of receiving short message service (SMS) communications and viewing PDF documents
I am 18 or older and work at or recently retired from LHSC or Western University.
I am able to understand and agree to participate in this study.
See 2 more

Exclusion Criteria

Medical conditions precluding safe exercise without physician clearance, including unstable angina, uncontrolled arrhythmia, severe heart failure
I do not have severe cognitive problems that stop me from consenting or using study tools.
Inability to read and understand English
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 months
1 visit (in-person)

Treatment

Participants receive either the BASIC-S intervention or standard care for six months

6 months
Monthly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Final assessment at 6 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

  • BASIC-S Intervention

Trial Overview

The study compares the BASIC-S program—which uses coaching, video check-ins, texts, and a digital workbook to encourage healthy habits—to usual care. Households are randomly assigned to one of these groups in this small pilot trial.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BASIC-S Intervention GroupExperimental Treatment1 Intervention
Group II: Standard Care (Usual Care) GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Andrew Appleton

Lead Sponsor

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials
17
Recruited
1,600+

Citations

Type and effectiveness of community-based interventions ...

Overall, most studies showed that CBIs significantly improved knowledge related to CVDs. Conclusion: Community-based CVD preventive interventions are effective ...

Community-Based Interventions for Cardiovascular Disease ...

Community-based interventions successfully improved population knowledge on CVD and risk factors and influenced physical activity and dietary practices.

Implementation of Evidence-Based Behavioral ...

Extending cardiovascular disease prevention beyond health care settings is needed to improve population health and to advance health equity.

Identifying optimal primary prevention interventions for major ...

BP-lowering interventions were associated with a 21% reduction in the risk of CVD mortality (estimate = 0.79, CI 0.66 to 0.94; p = 0.007), ...

CVD Prevention | What We Do

An estimated 80% of cardiovascular disease, including heart disease and stroke, is preventable. The main elements of CVD prevention are healthy diet, physical ...

BASIC Definition & Meaning

The meaning of BASIC is of, relating to, or forming the base or essence : fundamental. How to use basic in a sentence.

Basic (2003)

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en.wikipedia.org

en.wikipedia.org/wiki/BASIC

Basic

BASIC is a family of general-purpose, high-level programming languages designed for ease of use. The original version was created by John G. Kemeny and ...

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BASIC: Home

BASIC provides an HR ecosystem to employers and health insurance agents nationwide, with a suite of HR Benefit, Compliance, Payroll, and Leave Management ...

BASIC | definition in the Cambridge English Dictionary

simple and not complicated, so able to provide the base or starting point from which something can develop: I really need to get some basic financial advice.