200 Participants Needed

CVD-FIT for Cardiovascular Disease

(CVD-FIT Trial)

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Overseen ByRebekah J Walker, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
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?

This trial aims to determine if a new program, CVD-FIT, can help African Americans with food insecurity reduce their risk of heart disease. The program provides extra monthly income, a weekly incentive for purchasing healthy foods, and phone-based education on lowering heart disease risk. Participants will receive either the full package or just the education component. The trial seeks African Americans who have experienced food insecurity in the past year and have conditions such as diabetes, high blood pressure, or are overweight.

As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to innovative solutions for heart disease prevention in underserved communities.

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

What prior data suggests that this intervention is safe for cardiovascular disease risk reduction in African Americans with food insecurity?

A previous study demonstrated that physical activity and good heart and lung fitness improve health, including reducing the risk of heart disease. This approach is generally considered safe and beneficial for heart health.

The CVD-FIT program provides financial support, healthy food incentives, and education through phone calls. These activities focus on improving lifestyle habits and are unlikely to cause harm. Although specific data on negative effects is not available, these non-invasive methods are generally regarded as safe based on their purpose and design.

While researchers continue to test the CVD-FIT treatment, its emphasis on diet, financial support, and education suggests it is low-risk. Participants can expect interventions designed to support heart health in a practical and safe manner.12345

Why are researchers excited about this trial?

Researchers are excited about CVD-FIT for cardiovascular disease because it combines financial incentives with education to encourage healthier lifestyle choices, which is quite different from traditional treatments like medication or surgery. Unlike standard care, which often focuses on managing symptoms with drugs, CVD-FIT provides monthly income supplements and reimburses the purchase of healthy foods, actively encouraging participants to make heart-healthy choices. This approach is designed to not only reduce cardiovascular risk but also empower individuals through education and direct support, potentially leading to more sustainable lifestyle changes.

What evidence suggests that CVD-FIT could be an effective treatment for cardiovascular disease?

Research has shown that regular physical activity and exercise can greatly reduce the risk of heart disease and improve overall health. People who exercise frequently are less likely to develop heart problems and tend to live longer. In this trial, the CVD-FIT program, which participants may receive, offers rewards for healthy food choices and provides education on reducing health risks. These features aim to boost heart health by promoting better lifestyle habits, a strategy strongly supported by research.678910

Are You a Good Fit for This Trial?

This trial is for African American adults with food insecurity who are at risk of cardiovascular disease, including those with sleep apnea. Participants should be interested in receiving additional income, buying healthy foods, and learning about heart health over the phone.

Inclusion Criteria

I am over 40 and have diabetes, high blood pressure, high cholesterol, am overweight, or smoke.
Self-report as African American/non-Hispanic Black
Screen positive for food insecurity over the past 12 months using a food insecurity risk tool developed through completion of the research team's current NIH funded R01 (R01MD013826)
See 1 more

Exclusion Criteria

Participation in other cardiovascular disease clinical trials
Alcohol or drug abuse/dependency based on screening using CAGE questionnaire
Mental confusion on interview suggesting significant dementia
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CVD-FIT intervention, which includes monthly income supplementation, weekly structured incentives for healthy food purchases, and telephone-delivered CVD risk reduction education and skills training

12 months
Visits at baseline, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CVD-FIT
Trial Overview The study tests CVD-FIT against Enhanced Usual Care to see if it's more effective and cost-efficient. CVD-FIT includes extra monthly income, incentives for healthy eating each week, and phone-based education on reducing heart disease risks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CVD-FITExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

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.
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

an analysis using statistical and machine learning algorithmsThe overall crude incidence rate of CVD events was 9.9 new cases per 100 person-years. The highest rates among its component outcomes were ...
Epidemiology and Cardiovascular Benefits of Physical ...A vast amount of data suggest that PA and exercise are among the most powerful modifiable risk factors for general health, CVD, and mortality.
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.
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.
Exercise and cardiovascular health: A state-of-the-art reviewIn this state-of-the-art review, we evaluate the benefits of exercise on CV health, the physiological adaptations by which exercise decreases CVD risk, and ...
Physical Activity and Lifetime Risk of Cardiovascular ...In men, the lifetime risks of CVD from 45 through 85 years were 52.7% (95% confidence interval, 49.4–55.5) for poor PA and 45.7% (42.7–48.3) for recommended PA.
Cardiorespiratory Fitness and Classification of Risk ...Ten-year risk estimates for CVD mortality were categorized as <1%, 1% to <5%, and ≥5%, and 25-year risk estimates were categorized as <8%, 8% to ...
Physical activity for cardiovascular preventionEngaging in physical activity (PA) and maintaining adequate cardiorespiratory fitness is associated with health advantages for all individuals.
9.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37296355/
Cardiovascular disease (CVD) outcomes and associated ...The highest rates among its component outcomes were obtained for CAD or PAD (3.6 for each), followed by HF (2.2) and AF (1.8), then IS (1.3), ...
Lifetime Risks for Cardiovascular Disease Mortality by ...A single measurement of low fitness in mid-life was associated with higher lifetime risk for CVD death, particularly among persons with a high burden of CVD ...
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