CVD-FIT for Cardiovascular Disease

(CVD-FIT Trial)

Overseen By Rebekah J Walker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Alcohol abuse, Drug abuse, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

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

What data supports the effectiveness of the treatment CVD-FIT for cardiovascular disease?

Intensive lifestyle modification programs, which are similar to CVD-FIT, have shown benefits in reducing primary cardiovascular disease risk factors and improving coronary disease risk, especially in individuals at increased risk of cardiovascular disease. ^{1 2 3 4 5}

How is the CVD-FIT treatment different from other treatments for cardiovascular disease?

CVD-FIT is unique because it focuses on improving cardiovascular fitness, which is linked to reduced risk of cardiovascular disease and hospital admissions, rather than relying solely on traditional risk factors or medications. ^{6 7 8 9 10}

What is the purpose of this trial?

The overarching aim of this proposal is to test the efficacy and cost-effectiveness of CVD-FIT, a novel, multi-component intervention that includes three components: 1) monthly income supplementation; 2) weekly structured incentive for the purchase of healthy food options; and 3) evidence-based telephone delivered CVD risk reduction education and skills training in African Americans with food insecurity.

Eligibility Criteria

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)

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: CVD-FIT Experimental Treatment 1 Intervention

The structured incentive will include monthly supplemental income plus weekly reimbursement for the purchase of healthy food options. Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.

Group II: Enhanced Usual Care Active Control 1 Intervention

Education for CVD risk reduction will include mailed education and telephone calls with a trained health educator.

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+

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. Poland pubmed.ncbi.nlm.nih.gov

Ten-year risk of fatal cardiovascular disease in the Polish population and medical care. Results of the WOBASZ study. [2018]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Prevalence of Self-reported Cardiovascular Risk Factors among Saudi Physicians: A Comparative Study. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

European Practice Assessment of Cardiovascular risk management (EPA Cardio): protocol of an international observational study in primary care. [2022]

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

Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Peripheral Arterial and Ischemic Cerebrovascular Disease Compared to Veterans With Coronary Heart Disease. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Cardiovascular fitness, physical activity and selected coronary heart disease risk factors in adults. [2017]

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

Peak oxygen uptake and incident coronary heart disease in a healthy population: the HUNT Fitness Study. [2020]

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

Prediction of 30-year risk for cardiovascular mortality by fitness and risk factor levels: the Cooper Center Longitudinal Study. [2023]

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

Maintaining or increasing cardiorespiratory fitness is associated with reduced hospital admission rate. [2023]

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

Preventive fraction of physical fitness on risk factors in cardiac patients: Retrospective epidemiological study. [2020]