HeartBeet Clinic for High Cholesterol and High Blood Pressure

Overseen By Stephanie Hooker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Must be taking: Statins, Anti-obesity, Antihypertensives

Disqualifiers: Coronary artery disease, Stroke, Dementia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of two programs for individuals with high cholesterol or high blood pressure. One group will participate in a 16-week lifestyle program with virtual coaching at the HeartBeet Clinic, while the other will engage in an online self-paced learning program. The trial aims to assess the programs' appeal and ease of use, which will inform the planning of a larger study. HealthPartners patients with high cholesterol or high blood pressure who can attend weekly online group sessions may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to research that could influence future health programs.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires participants to maintain their current doses of statin, anti-obesity medication, and/or antihypertensive medication during the study.

What prior data suggests that this lifestyle medicine program is safe?

Research has shown that many studies on lifestyle programs like the HeartBeet Clinic have not fully reported negative effects, complicating a complete understanding of the program's safety. However, since this trial involves lifestyle changes rather than medication or surgery, it is likely manageable for most people. Lifestyle programs typically emphasize diet and exercise, which generally pose fewer risks than medical treatments. Participants will follow a structured plan with online group coaching, which should be safe for most individuals. Consulting a doctor is essential to determine if this type of program is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for high cholesterol and high blood pressure, which often rely on medication, the HeartBeet Clinic offers a 16-week group-based lifestyle intervention. This approach emphasizes lifestyle changes, such as diet and exercise, which can empower individuals to manage their health actively and sustainably. Researchers are excited about this method because it utilizes community support and education to potentially achieve long-lasting improvements without the side effects associated with medication. Additionally, there's an active comparator involving self-paced online learning, allowing participants to engage with lifestyle medicine at their own pace, offering flexibility and convenience.

What evidence suggests that this trial's treatments could be effective for high cholesterol and high blood pressure?

Studies have shown that lifestyle changes can effectively manage high cholesterol and high blood pressure. For instance, research indicates that 85% of people in an online heart health program reached their target blood pressure. Another study found that 71% of participants achieved their goal for LDL cholesterol, the "bad" cholesterol linked to heart disease. This trial will compare two approaches: the HeartBeet Clinic, a 16-week group-based lifestyle intervention, and a self-paced education program through online learning. These findings suggest that lifestyle programs like the HeartBeet Clinic might improve heart health by lowering blood pressure and cholesterol levels, potentially reducing the risk of heart-related issues, such as hospital visits, by more than half. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for HealthPartners patients with high cholesterol or blood pressure, willing to attend weekly virtual coaching for 16 weeks and pay any related costs not covered by insurance. Participants must have had a clinician visit in the past year, be able to use technology for the intervention, and agree to keep their medication doses constant.

Inclusion Criteria

I can attend weekly group sessions for 4 months.

I have access to a computer, smartphone, and internet.

I have seen a HealthPartners or Park Nicollet doctor in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the HeartBeet Clinic group will undergo a 16-week lifestyle medicine program with virtual, small-group coaching, including 12 group coaching sessions, 6 skills sessions, and 6 deep dives. The self-paced education group will access an online course and workbook.

16 weeks

2 visits (in-person), multiple virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of acceptability and cardiovascular health.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• HeartBeet Clinic
• Self-paced education

Trial Overview

The HeartBeet Clinic's pilot study tests a 16-week lifestyle program with group coaching against self-paced online education. It aims to assess how acceptable and feasible these methods are before launching a larger trial focused on effectiveness.

How Is the Trial Designed?

Group I: HeartBeet Clinic Experimental Treatment 1 Intervention

16 week group based lifestyle intervention

Group II: Self-paced education Active Control 1 Intervention

Online learning of lifestyle medicine

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Published Research Related to This Trial

In a study involving 40 moderately hypercholesterolemic participants, a yogurt drink containing 4g of plant stanol esters (Benecol®) significantly reduced total cholesterol by 7.2% and LDL cholesterol by 10.3%.

The study suggests that higher doses of plant stanol esters can effectively lower cholesterol levels, which is important since reducing LDL cholesterol can decrease the risk of coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of yogurt drink with added plant stanol esters (Benecol®, Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798. Vásquez-Trespalacios, EM., Romero-Palacio, J.[2021]

Group medical clinics significantly improved lipid management in patients with uncontrolled diabetes and hypertension, resulting in lower total cholesterol and LDL-C levels compared to usual care, with reductions of 14.2 mg/dL and 9.2 mg/dL respectively.

Patients in group medical clinics were more likely to meet LDL-C goals (76% vs. 61% in usual care) and experienced greater intensification of cholesterol-lowering medications, suggesting that this model of care may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can group medical clinics improve lipid management in diabetes? Crowley, MJ., Melnyk, SD., Ostroff, JL., et al.[2022]

The HeartBeat Connections (HBC) telemedicine program effectively engaged one-third of high-risk individuals aged 40-79, leading to significant improvements in tobacco cessation and achieving LDL cholesterol goals, indicating its potential to reduce cardiovascular disease (CVD) risk.

Participants with higher engagement in the HBC program showed more favorable improvements in total and LDL cholesterol levels, suggesting that increased interaction with health coaches can enhance the effectiveness of primary prevention strategies for CVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reach and effectiveness of the HeartBeat Connections telemedicine pilot program. Benson, GA., Sidebottom, A., Sillah, A., et al.[2018]

Risk assessment algorithms, like those from the Adult Treatment Panel III, help classify patients' cardiovascular risk and guide the intensity of treatment needed, especially for those at highest risk.

The presence of metabolic syndrome increases the risk of diabetes and cardiovascular disease, highlighting the importance of both pharmacotherapy and lifestyle changes for all patients, regardless of their risk level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular and metabolic risk factors: how can we improve outcomes in the high-risk patient? Grundy, SM.[2019]

In a screening of 629 adults aged 45-64 in Lede, Belgium, significant cardiovascular risk factors were identified, including high cholesterol (38%), elevated blood pressure (22% for systolic and 8% for diastolic), and increased fasting glucose (8.6%).

Among those receiving treatment, only 13% of women and 34% of men achieved the LDL cholesterol target of 115 mg/dl, while 40% reached the target for systolic blood pressure and 75% for diastolic blood pressure, indicating challenges in meeting treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a cardiovascular prevention campaign in persons aged 45-64 years. Devroey, D., de Swaef, N., Coigniez, P., et al.[2013]

A study at a tertiary medical center found that 69% of patients receiving statins for primary prevention and 47% for secondary prevention were overtreated, indicating a significant misalignment with national guidelines.

Conversely, 88% of patients with established coronary heart disease were found to be undertreated, highlighting a critical gap in statin therapy for those at high cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and monitoring of "statin" lipid-lowering drugs compared with guidelines. Abookire, SA., Karson, AS., Fiskio, J., et al.[2019]

Elevated levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) are major risk factors for coronary heart disease (CHD), while high levels of high-density lipoprotein cholesterol (HDL-C) are protective against it.

Recent studies highlight the potential of nutraceuticals and functional foods as alternative therapies for lowering plasma TC, particularly for patients with marginally high cholesterol levels (200-240 mg/dL) who may not require medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholesterol-lowering nutraceuticals and functional foods. Chen, ZY., Jiao, R., Ma, KY.[2017]

The Healthy Heart Community Prevention Project (HHCPP) effectively uses community venues like barbershops and beauty salons for blood pressure screenings, targeting African American populations in New Orleans who face higher cardiovascular risks.

The program includes educational initiatives for health professionals and community engagement through church sermons and sports events, demonstrating a comprehensive approach to reducing cardiovascular disease in low socioeconomic status groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from the Healthy Heart Community Prevention Project in reaching the African American population. Ferdinand, KC.[2022]

The National Cholesterol Education Program recommends that all adults have their cholesterol checked at least once every 5 years, similar to the successful hypertension program.

For individuals with cholesterol levels above 200 mg/dl, dietary changes are advised, and those with levels above 240 mg/dl may require more intensive treatment, including medication, but only after confirming low-density lipoprotein cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national program for lowering high blood cholesterol. Hulley, SB.[2019]

In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health products (NHPs) concurrently, which significantly increased their risk of experiencing adverse events (AEs).

Patients using both prescription drugs and NHPs were 6.4 times more likely to report an AE compared to those using only prescription drugs, highlighting the importance of monitoring concurrent use for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. Necyk, C., Tsuyuki, RT., Boon, H., et al.[2022]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

In a study of 359 adults with mild hypercholesterolemia, the nutraceutical LopiGLIK® was found to be significantly more effective than Armolipid Plus® in achieving therapeutic targets for LDL cholesterol, with 72% of LopiGLIK® users reaching the target compared to only 43% for Armolipid Plus® (p < 0.0001).

Both treatments improved lipid profiles and reduced blood pressure, but LopiGLIK® showed greater reductions in total cholesterol, LDL cholesterol, triglycerides, and other metabolic parameters, indicating it may be a superior option for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single blind, multicentre, randomized, controlled trial testing the effects of a novel nutraceutical compound on plasma lipid and cardiovascular risk factors: Results of the interim analysis. Trimarco, V., Battistoni, A., Tocci, G., et al.[2022]

A review of 48 studies on plant food supplements for cardiovascular health revealed that most studies were of low methodological quality, primarily due to poor reporting of adverse events and patient withdrawals.

The studies mainly focused on short-term effects (less than one month) and evaluated cardiovascular risk factors like lipid levels, heart function, and blood pressure, indicating a need for longer and more rigorously designed trials to better assess the safety and efficacy of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of existing experimental approaches for the clinical evaluation of the benefits of plant food supplements on cardiovascular function. Meoni, P., Restani, P., Mancama, DT.[2013]

A survey of 67 Austrian physicians revealed that nearly all recommend dietary changes for patients with total cholesterol levels above 250 mg/dl and prescribe lipid-lowering medications for levels above 300 mg/dl, indicating a strong emphasis on dietary intervention in coronary prevention.

Most physicians spend limited time (up to 5 minutes) with patients suffering from hyperlipidemia, suggesting a need for more time and specialized education to improve patient care and outcomes in coronary prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of coronary risk factors by general practitioners in Austria]. Schwarz, B., Hartl, H., Rieder, A., et al.[2019]

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