Health Impact 360 for Cardiovascular Health

(HI360 Trial)

Recruiting at 2 trial locations

Overseen By Michelle Clayson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

328 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called Health Impact 360, designed to improve heart health in people from marginalized communities. The program focuses on areas such as healthy eating, exercise, and quitting smoking. Researchers seek to determine if participants experience better heart health, reduced stress, and improved social support after 16 weeks compared to those who do not start the program immediately. Participants who speak English or Spanish and can join group sessions are a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart health solutions tailored for diverse 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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Health Impact 360 intervention is safe for cardiovascular health?

Research has shown that the Health Impact 360 program aims to improve heart health through lifestyle changes such as exercise, healthy eating, and stress management. In a similar program for Parkinson's Disease, which also included exercise and diet, researchers found no major safety issues. Participants in that study handled the program well, suggesting that Health Impact 360 might also be safe for most people.

This trial is in the "Not Applicable" phase, focusing on collecting information and assessing the program's practicality. While safety data might be limited, the program is likely considered low-risk because it involves lifestyle changes rather than new medications or surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Health Impact 360 because it offers a comprehensive approach to cardiovascular health that goes beyond the standard medication and lifestyle advice. Unlike typical treatments that often focus on medication for blood pressure or cholesterol alone, this program combines healthy eating, physical activity, quality sleep, and tobacco cessation with clinical measures like monitoring blood pressure, cholesterol, Hemoglobin A1c, and BMI. This holistic approach aims to address multiple dimensions of heart health simultaneously, potentially leading to more sustainable and impactful improvements.

What evidence suggests that Health Impact 360 is effective for cardiovascular health?

Research shows that the Health Impact 360 program, which participants in this trial may receive, can greatly improve heart health. Previous studies on similar programs that include exercise, mindfulness, and healthy eating have improved key health measures like blood pressure and cholesterol. Participants often reported better mental well-being, experiencing less stress and more social support. These benefits are linked to maintaining heart-healthy habits such as regular exercise and a balanced diet. While the specific results of Health Impact 360 are still under study in this trial, this approach appears promising for enhancing heart health and overall well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer Garner, PhD, RD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults in marginalized communities aiming to improve cardiovascular health. Participants should be interested in group-based programs and willing to self-monitor physical activity. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I can join and participate in group activities.

I speak English or Spanish.

Exclusion Criteria

All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in group-based programming twice per week for 8 weeks, then once per week for 8 weeks, and self-monitor physical activity via a pedometer

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with survey-based and biometric data collection at baseline and 16-week endpoint

4 weeks

Open-label extension (optional)

Delayed intervention control participants are invited to participate in Health Impact 360 after endpoint measures are collected

16-20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Impact 360

Trial Overview The Health Impact 360 intervention, which includes group sessions and self-monitoring with a pedometer, is being tested against a wait list control group for its effectiveness in improving cardiovascular, mental, and social health over 16 weeks.

How Is the Trial Designed?

Group I: Usual care - Wait list control Experimental Treatment 1 Intervention

Participants that will be on the wait list will be evaluated. These participants will be enrolled into the treatment program 16-20 weeks after the first treatment group.

Group II: Health Impact 360 Experimental Treatment 1 Intervention

16-week, group-based comprehensive health program that covers all behavioral and clinical dimensions of heart health: healthy eating, physical activity, quality sleep, tobacco cessation, blood pressure, cholesterol, Hemoglobin A1c, and Body Mass Index.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Detroit Hispanic Development Corporation

Collaborator

Eastside Community Network

Collaborator

Community Health and Social Service Center (CHASS)

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07034352

Health Impact 360: Advancing Physical, Social, and Mental ... The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06516146

Study Details | NCT06516146 | Impact 360 for Healthy Agers The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03308812

The Morehouse-Emory Cardiovascular Center for Health ... This study will recruit from participants in the Morehouse-Emory Cardiovascular (MECA) study for a clinical intervention examining cardiac outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12093147/

Artificial intelligence to improve cardiovascular population health Use of artificial intelligence in improving outcomes in heart disease: a scientific statement from the American Heart Association.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Several studies suggest that patients participating in home-based cardiac rehabilitation (HBCR) report higher satisfaction, better exercise adherence, and ...

6. archivesofmedicalscience.com archivesofmedicalscience.com/A-360-perspective-on-cardiovascular-prevention-the-International-Lipid-Expert-Panel,205732,0,2.html

A 360° perspective on cardiovascular prevention Cardiovascular disease (CVD) remains the leading cause of mortality globally, accounting for over 20 million deaths annually, with as many as 2/ ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039031

Impact of Social Determinants of Health on Cardiovascular ... In conclusion, SDoHs significantly impact cardiovascular morbidity and death and specific outcomes of patients with cardiovascular disease.

8. mdsabstracts.org mdsabstracts.org/abstract/impact-360-study-for-parkinsons-disease-a-controlled-phase-ii-feasibility-and-safety-study-of-a-combined-exercise-diet-and-mindfulness-intervention/

Impact 360 Study for Parkinson's Disease – a controlled ... Impact 360 Study for Parkinson's Disease – a controlled phase II feasibility and safety study of a combined exercise, diet and mindfulness intervention.