Virtual Lifestyle Intervention for Cardiovascular Disease

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Truemedicine Inc
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?

The trial aims to evaluate how a virtual lifestyle program, known as the Virtual Lifestyle Intervention, can enhance weight management and heart health. Participants will engage in a 90-day program that includes exercise via the Peloton platform, daily supplements, and educational content. This study suits individuals who exercise less than 60 minutes per week and meet specific heart health criteria, such as a larger waist size or high blood pressure. Participants must have or be willing to obtain a Peloton membership and own a compatible fitness tracker. The remote nature of the trial allows easy participation from home. As an unphased trial, it provides a unique opportunity to explore innovative lifestyle interventions in a convenient setting.

What prior data suggests that this virtual lifestyle intervention is safe for cardiovascular health?

Research has shown that lifestyle changes, like those in this study, are generally safe and manageable. These changes can help control weight and reduce heart disease risk without causing major issues. For instance, improving diet and exercise can enhance blood pressure and cholesterol levels, which are crucial for heart health.

Other studies on similar lifestyle programs have not reported serious side effects. The supplements used in this trial, including Omega-3s, Vitamin D3, Magnesium Malate, and fiber, are also typically safe when taken as directed. However, following dosage guidelines and consulting healthcare providers if concerns arise is always important.12345

Why are researchers excited about this trial?

Most treatments for cardiovascular disease focus on medication, surgery, or lifestyle changes like diet and exercise, often managed separately. But this Virtual Lifestyle Intervention is unique because it combines structured aerobic exercise via the Peloton platform with daily supplements like Omega-3, Vitamin D3, Magnesium Malate, and fiber, all in one comprehensive program. The use of wearable technology for tracking activity and sleep, along with structured educational content, makes it a holistic approach. Researchers are excited because this integrated method could make it easier for patients to adopt and stick with heart-healthy habits, potentially leading to better outcomes.

What evidence suggests that this virtual lifestyle intervention is effective for cardiovascular disease?

Research has shown that lifestyle changes can greatly improve heart health. One study found that these changes help control blood sugar and cholesterol, which are important for preventing heart disease. Other research has discovered that online lifestyle programs can lower heart risks by promoting healthier habits. Supplements like Omega-3 and Vitamin D3 also support heart health. This trial will test a combined approach through a virtual lifestyle program, which includes structured aerobic exercise, daily supplementation, wearable-based activity and sleep tracking, and structured educational content, to effectively improve heart health and aid in weight management.25678

Are You a Good Fit for This Trial?

Inclusion Criteria

Stable body weight, defined as no change of more than 5 pounds (2.3 kg) in the three months prior to enrollment
Sedentary lifestyle, defined as fewer than 60 minutes of structured exercise per week
Willing and able to collect at-home dried blood spot (DBS) samples using a provided kit at three designated timepoints
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Exclusion Criteria

Pregnant or breastfeeding individuals
I am able to understand and agree to participate in the study.
I am not willing to use Peloton equipment or get a Peloton digital membership.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 90-day multicomponent lifestyle intervention including structured aerobic exercise via Peloton, daily supplementation, wearable-based monitoring, and educational content

12 weeks
Fully virtual

Follow-up

Participants are monitored for changes in body weight, waist circumference, cardiovascular biomarkers, and quality of life after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Lifestyle Intervention

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Multicomponent Lifestyle InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Truemedicine Inc

Lead Sponsor

Citations

Virtual Lifestyle Intervention for Weight Management and ...

Secondary outcomes include cardiovascular biomarkers measured through dried blood spot sampling, quality of life assessments, body composition ...

Impact of lifestyle-based interventions on absolute ... - PMC

The objective of the review was to synthesize the evidence on the effectiveness of lifestyle-based interventions in mitigating absolute cardiovascular disease ...

Digital lifestyle interventions for cardiovascular risk reduction

This study aimed to assess the effectiveness of various digital lifestyle interventions in improving cardiovascular risk factors.

Effect of Intensive Lifestyle Intervention on Cardiovascular ...

Intensive lifestyle intervention was significantly associated with lower long‐term variability of fasting blood glucose, total cholesterol, and ...

The Effectiveness of Lifestyle Physical Activity Interventions to ...

The lifestyle intervention prevented development of type 2 diabetes in 58% of those individuals compared to placebo and was also more effective than metformin.

Virtual Lifestyle Intervention for Weight Management and ...

Secondary outcomes include cardiovascular biomarkers measured through dried blood spot sampling, quality of life assessments, body composition ...

Virtual Lifestyle Intervention for Weight Management and ...

Primary outcomes include changes in body weight and waist circumference measured at baseline and day 90. Secondary outcomes include ...

A systematic review and meta-analysis testing the effect ... - PMC

Lifestyle modification and medication optimization interventions had a significant effect on monitoring blood pressure and serum cholesterol; ...