Lifestyle Interventions for Heart Disease Risk Reduction

(HeartSCORE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Limited life expectancy, pregnancy, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand and reduce heart disease risk by comparing usual care with a special program focused on improving habits like nutrition, exercise, and stress management. Researchers will sort participants into groups to determine if lifestyle changes significantly lower heart disease risk compared to receiving advice alone. The trial is ideal for Pennsylvania residents who have been informed by a doctor of a moderate to high heart disease risk affecting their daily life. As an unphased trial, it offers participants a unique opportunity to contribute to groundbreaking research that could enhance heart health strategies.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lifestyle changes like exercising, eating healthy, and managing stress can safely reduce the risk of heart disease. Studies indicate that regular moderate activities, such as walking or cycling, improve heart health and lower the chance of heart attacks when done consistently and not excessively.

Eating a balanced diet that's good for the heart, such as the Mediterranean or DASH diet, links to a lower risk of heart disease. These diets emphasize fruits, vegetables, and whole grains while reducing processed foods, proving effective and safe for most people.

Managing stress is another key factor. Techniques like meditation and yoga have shown to reduce stress and improve heart health without major side effects.

In summary, these lifestyle changes are generally safe and can significantly lower the risk of heart disease. Research suggests they are well-tolerated and beneficial for heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for heart disease risk reduction because they take a holistic approach, focusing on individualized advice for nutrition, exercise, and stress management. Unlike standard treatments that often rely on medication, these interventions aim to empower individuals to make sustainable lifestyle changes, potentially reducing the need for medication and its associated side effects. This approach could lead to more personalized care, addressing not just the symptoms but the root causes of cardiovascular disease risk. By offering tailored guidance, the intervention has the potential to be more effective in promoting long-term heart health.

What evidence suggests that this trial's treatments could be effective for reducing cardiovascular risk?

This trial will compare different lifestyle interventions for reducing heart disease risk. Research has shown that physical activity can significantly lower heart disease risk. Regular exercise contributes to a healthier heart, better blood sugar control, and lower blood pressure. A diet rich in fruits and vegetables also helps lower blood pressure and improve cholesterol levels. Managing stress is crucial as well; programs that reduce stress have improved health outcomes for people with heart disease. Participants in this trial may receive individualized advice on nutrition, exercise, and stress management counseling, which together can promote a healthier heart and reduce the risk of heart problems. ^{2 5 6 7 8}

Who Is on the Research Team?

Steven E Reis, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for Pennsylvania residents aged 45-75 who may be at risk of heart disease. It's not suitable for those with a life expectancy under 5 years, unable to attend regular visits, or pregnant women (excluded from X-ray studies).

Inclusion Criteria

I am between 45 and 75 years old.

Exclusion Criteria

Pregnancy (exclude women from X-ray studies)

I have a health condition that may shorten my life to under 5 years.

Inability to undergo baseline or annual follow-up visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive 6 months of individualized advice regarding Nutrition, Exercise, and Stress Management Counseling

6 months

Regular visits for counseling sessions

Usual Care

Participants receive usual care without active counseling

6 months

Follow-up

Participants are monitored for cardiovascular events

20 years

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Nutrition
• Stress Management Counseling
• usual care

Trial Overview The study tests if better risk identification and community programs like nutrition advice, exercise routines, and stress management can reduce heart disease risks in high-risk groups. Participants will either receive usual care or join the intervention program.

How Is the Trial Designed?

Group I: 1 Active Control 1 Intervention

Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1

Group II: 3 Active Control 1 Intervention

No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling

Group III: 2 Placebo Group 1 Intervention

Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Pennsylvania Department of Health

Collaborator

Trials

42

Recruited

999,000+

Published Research Related to This Trial

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2022.07.004

Exercise for Primary and Secondary Prevention of ... Regular exercise that meets or exceeds the current physical activity guidelines is associated with a reduced risk of cardiovascular disease (CVD) and mortality.

3. escardio.org escardio.org/Councils/Council-for-Cardiology-Practice-(CCP)/Cardiopractice/physical-activity-for-cardiovascular-prevention

Physical activity for cardiovascular prevention Engaging in physical activity is essential for everybody and has a substantial impact on cardiovascular health, contributing to a 27% reduction ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460131/

The Effectiveness of Exercise in Reducing Cardiovascular ... This study aimed to assess the effectiveness of various forms of physical activity in reducing CVD risk factors among adults.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481017/

Exercise for Prevention and Relief of Cardiovascular Disease Physical activity can improve insulin sensitivity, alleviate plasma dyslipidemia, normalize elevated blood pressure, decrease blood viscosity, ...

6. nhlbi.nih.gov nhlbi.nih.gov/health/heart/physical-activity/benefits

Physical Activity and Your Heart - Benefits | NHLBI, NIH Physical activity reduces heart attack risk​​ For people who have coronary heart disease, regular aerobic activity helps the heart work better. ...

7. heart.org heart.org/en/healthy-living/fitness/fitness-basics/aha-recs-for-physical-activity-in-adults

AHA Physical Activity Recommendations ... Get at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination ...

8. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active. Regular physical ...