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

2000 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Lifestyle Interventions for Heart Disease Risk Reduction?

Research shows that lifestyle interventions, including diet and exercise, can effectively reduce risk factors for heart disease, such as high cholesterol and blood pressure. Multifactorial approaches, which combine several lifestyle changes, are particularly effective in reducing cardiovascular disease risk, especially in individuals with multiple risk factors. ^{1 2 3 4 5}

Is it safe to participate in lifestyle interventions for heart disease risk reduction?

Lifestyle interventions like exercise, healthy eating, and quitting smoking are generally safe and can help reduce the risk of heart disease. These approaches are supported by research and are recommended as first-line interventions for conditions like high blood pressure and high cholesterol. ^{4 6 7 8 9}

How does the usual care treatment for heart disease risk reduction differ from other treatments?

Usual care for heart disease risk reduction often involves community-based lifestyle interventions, which are unique because they focus on education and support through exercise, diet, and smoking cessation programs, often delivered in partnership with organizations like the YMCA. These programs are designed to be accessible and cost-effective, providing alternatives for those who may not have access to traditional healthcare settings. ^{10 11 12 13 14}

What is the purpose of this trial?

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify disparities in cardiovascular risk based on race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations. These goals, which are designed to eliminate ethnic and racial health disparities, are closely tied to the National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's health promotion and disease prevention agenda established in Healthy People 2010. This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with approximately equal representation of white and African American subjects. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate racial, socioeconomic and geographic disparities in cardiovascular risk. All participants will undergo long-term follow-up for cardiovascular events.

Research Team

Steven E Reis, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Internet programs targeting multiple lifestyle interventions in primary and secondary care are not superior to usual care alone in improving cardiovascular risk profile: a systematic review. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improving lifestyle and risk perception through patient involvement in nurse-led cardiovascular risk management: a cluster-randomized controlled trial in primary care. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of individual lifestyle interventions in reducing cardiovascular disease and risk factors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Lifestyle therapy changes and hypercholesterolemia: identifying risk groups in a community sample of Blacks and Whites. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular disease: optimal approaches to risk factor modification of diet and lifestyle. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Use of lifestyle interventions in primary care for individuals with newly diagnosed hypertension, hyperlipidaemia or obesity: a retrospective cohort study. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[Prognostic effects of cardiac rehabilitation in patients with acute coronary syndrome]. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A Swedish primary healthcare prevention programme focusing on promotion of physical activity and a healthy lifestyle reduced cardiovascular events and mortality: 22-year follow-up of 5761 study participants and a reference group. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Community-Based Healthy Living Interventions. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Best practices in implementing lifestyle interventions in the WISEWOMAN program: adaptable strategies for public health programs. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial. [2021]

13. France pubmed.ncbi.nlm.nih.gov

[Therapeutic education in primary cardiovascular prevention. Interests and limits]. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Efficacy of multifactorial lifestyle interventions in patients with established cardiovascular diseases and high risk groups. [2012]