Vitalis Cardio for Cardiovascular Risk

Overseen By Lucas J Carr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lucas Carr

Disqualifiers: Unstable psychiatric disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 12-week program called Vitalis Cardio, designed to help individuals with at least one heart disease risk factor, such as high blood pressure or obesity, improve their health. The trial evaluates whether counseling and health coaching can enhance habits like exercise, healthy eating, and good sleep. Participants will wear activity monitors to track their progress. It suits adults who wish to become more active, own a smartphone, and seek support to improve their lifestyle. As an unphased trial, it offers a unique opportunity for participants to receive personalized support and potentially enhance their health habits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral counseling and lifestyle changes, so it's best to discuss your medications with the trial team.

What prior data suggests that this behavioral counseling intervention is safe for adults with CVD risk factors?

Research has shown that programs like Vitalis Cardio, which focus on lifestyle changes, are generally safe for adults with heart health concerns. Two studies found that home-based heart health programs, including health coaching and tracking physical activity, are safe and yield outcomes similar to regular medical care, with no increase in deaths or heart problems. This suggests that the Vitalis Cardio program, which also includes coaching and activity tracking, is well-received. Participants in similar programs have not experienced major health issues, making this a promising option for improving heart health through lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vitalis Cardio because it combines health coaching, health education, and wearable activity monitoring to manage cardiovascular risk. Unlike standard treatments that often rely solely on medication, this approach promotes lifestyle changes through personalized guidance and real-time feedback from wearable technology. This unique combination empowers individuals to actively participate in their health management, potentially leading to more sustainable long-term results.

What evidence suggests that this behavioral counseling intervention is effective for cardiovascular risk?

Research shows that the Vitalis Cardio program, which participants in this trial will receive, might help people with heart health risks improve their well-being by changing their habits. Past studies found that people in similar programs started exercising more and eating better, reducing the risk of heart disease. Participants in these studies often had lower blood pressure and lost weight. Many reported feeling better overall and having a smaller waist size. This evidence suggests that joining the Vitalis Cardio program could lead to healthier habits and improved health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The Vitalis Cardio Pilot trial is for adults with at least one cardiovascular disease (CVD) risk factor. It's designed to see if a 12-week counseling program in primary care can help improve their mental well-being, lifestyle habits like exercise and diet, and physical health measures such as blood pressure and weight.

Inclusion Criteria

I have a risk factor for heart disease (like high blood pressure or diabetes).

Own a smartphone with a data plan

Physically able to become more active

Exclusion Criteria

Pregnant or plan to become pregnant in the next 2 months

Does not own a smartphone with a data plan

Inability to read, complete, or sign the consent form and survey

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in a 12-week behavioral counseling intervention, including 5 meetings with a health coach, daily activity monitoring, and watching health education videos

12 weeks

5 visits (in-person or virtual)

Follow-up

Participants are monitored for psychosocial, behavioral, and health outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitalis Cardio

Trial Overview This study tests the 'Vitalis Cardio' intervention, which involves behavioral counseling over a period of 12 weeks. The goal is to enhance psychosocial outcomes, encourage healthier behaviors including increased physical activity, better diet, improved sleep patterns, and ultimately improve overall health indicators.

How Is the Trial Designed?

Group I: Vitalis Cardio Intervention Experimental Treatment 1 Intervention

The intervention includes health coaching, health education, and wearable activity monitoring.

Who Is Running the Clinical Trial?

Lucas Carr

Lead Sponsor

Trials

1

Recruited

10+

Google LLC.

Industry Sponsor

Trials

12

Recruited

31,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07001774

Study Details | NCT07001774 | Vitalis Cardio Pilot The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been ...

2. medrxiv.org medrxiv.org/content/10.1101/2025.09.17.25335262v1

The Vitalis Cardio Study Efficacy outcomes are assessed at baseline, post-intervention, with a subset of outcomes assessed after 12 weeks of post-intervention follow-up.

3. withpower.com withpower.com/trial/phase-cardiovascular-risk-8-2023-58017

Vitalis Cardio for Cardiovascular Risk The Vitalis Cardio Pilot trial is for adults with at least one cardiovascular disease (CVD) risk factor. It's designed to see if a 12-week counseling program ...

4. researchgate.net researchgate.net/publication/395685764_Methods_of_an_Exercise_is_Medicine-Mediated_Behavioral_Counseling_Intervention_in_Patients_At-Risk_for_Cardiovascular_Disease_The_Vitalis_Cardio_Study

Methods of an Exercise is Medicine-Mediated Behavioral ... Efficacy outcomes are assessed at baseline, post-intervention, with a subset of outcomes assessed after 12 weeks of post-intervention follow-up.

5. medrxiv.org medrxiv.org/content/10.1101/2025.09.17.25335262v1.full.pdf

Methods of an Exercise is Medicine-Mediated Behavioral ... Methods of an Exercise is Medicine-Mediated Behavioral Counseling Intervention in. Patients At-Risk for Cardiovascular Disease: The Vitalis ...

6. vitalishealth.in vitalishealth.in/facilities/

Advanced facilities for a comprehensive evaluation Our risk profiling considers factors like cholesterol levels, blood pressure, and lifestyle habits. Diabetes Prevention and Risk Reduction. Knowledge is power.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11367104/

Cardiac (tele)rehabilitation in routine clinical practice for ... Two systematic reviews suggest that home-based CR was safe, as no important differences in mortality, cardiac events, exercise capacity, ...

8. academic.oup.com academic.oup.com/ehjdh/article/6/5/1084/8178216

'Advancing Cardiovascular Risk Identification with Structured ... The ACRIBiS project presents an innovative concept to harmonize clinical data documentation and integrate ECG data, ultimately facilitating ...