Health Coaching for Heart Disease

(HEALTHCOACH Trial)

Overseen By Daniel Luger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-English/Spanish, Age, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual health coaching can assist individuals with heart disease risk factors in improving their health. By focusing on lifestyle changes such as diet and exercise, the trial aims to determine if coaching can reduce the likelihood of heart attacks, strokes, and related issues like high blood pressure and diabetes. Participants will engage in regular virtual coaching sessions and monitor their blood pressure at home. This trial suits English or Spanish speakers aged 40-75 who have at least one heart disease risk factor, such as high blood pressure or high cholesterol, and access to a device for telehealth. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health for many.

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 focuses on health coaching and lifestyle changes, so it's best to discuss your medications with the trial team.

What prior data suggests that this health coaching method is safe?

Studies have shown that health coaching is generally safe and easy to manage. Research indicates that personalized health coaching can reduce the risk of heart and metabolic diseases without causing serious side effects. Participants often find the sessions helpful and straightforward. Reports of negative effects from the coaching itself are rare. The coaching primarily involves discussing diet, exercise, and lifestyle changes, which are safe activities. For those considering joining a study, this type of coaching offers a low-risk way to improve health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard heart disease treatments that often focus on medication and surgery, this approach uses individualized health coaching to promote lifestyle changes tailored to each patient's needs. Researchers are excited about this because it empowers patients to take control of their health through regular coaching sessions, which are conducted by medical students and overseen by a licensed health coach. This method not only addresses physical health indicators like blood pressure and cholesterol but also considers factors like depression, sleep, and social determinants of health, offering a more holistic approach to heart disease management. The use of simple tools, like blood pressure cuffs and regular coaching, could make a big impact by potentially improving patient engagement and long-term health outcomes.

What evidence suggests that this health coaching is effective for heart disease?

Research has shown that health coaching can reduce the risk of heart disease and stroke. In this trial, participants will receive individualized health coaching sessions focused on lifestyle modifications relevant to their cardiometabolic health profile. One study found that health and wellness coaching lowered the 10-year risk of heart problems, including heart attacks and strokes. Another study demonstrated that lifestyle coaching reduced several risk factors for heart disease, such as high blood pressure and cholesterol. Health coaching also improves overall health by promoting better lifestyle choices, like diet and exercise. This approach is particularly beneficial in communities with limited access to healthcare. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Luger, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who are food insecure and at risk of heart disease, high cholesterol, hypertension, or diabetes. It's designed to help those who need lifestyle changes to improve their health. Participants will be screened for cardiovascular issues and must commit to virtual health coaching sessions.

Inclusion Criteria

Patient is a participant at a CHI sponsored, community screening event

Patient provides informed consent and willingness to participate for the duration of the study

At least 1 cardiometabolic risk factor at suboptimal level: Systolic BP greater than 130mmHg and/or diastolic BP greater than 80mmHg, Obesity: BMI greater than 30 kg/m^2, Dyslipidemia: Total cholesterol greater than 200 mg/dL, Triglycerides greater than 150 mg/dL, LDL greater than 130 mg/dL, HDL less than 40 mg/dL in men or less than 50 mg/dL in women, Hemoglobin A1c greater than or equal to 5.7%, 10-year ASCVD score greater than 5%, Access to a telehealth compatible device

Exclusion Criteria

All cardiometabolic risk factors at optimal levels

No telehealth compatible device

Pregnant patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Health Coaching

Participants receive biweekly virtual health coaching sessions for lifestyle modification, including diet and exercise guidance.

4 weeks

4 sessions (virtual)

Continued Health Coaching

Participants continue with monthly virtual health coaching sessions to monitor and adjust lifestyle changes.

8 weeks

2 sessions (virtual)

Follow-up

Participants are monitored for changes in cardiometabolic risk factors and accessibility to healthcare.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Longitudinal, Individualized Health Coaching

Trial Overview The study tests if regular virtual health coaching can lower the risk of heart attack or stroke over ten years, reduce blood pressure, cholesterol levels, and manage diabetes in a population that lacks access to sufficient food.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patients will receive health coaching sessions, conducted by medical students and overseen by a licensed health coach, directed at individualized lifestyle modification relevant to the patient's cardiometabolic health profile. Patients will receive blood pressure cuffs and will be instructed as to how to measure and keep a log of their blood pressure to be reviewed during health coaching sessions. Sessions will occur biweekly for 1 month followed by the next 2 months. Sessions will last approximately 15 minutes in length. Objective data including blood pressure, point-of-care lipid panel and hemoglobin A1c, 10-year atherosclerotic cardiovascular disease (ASCVD) risk score, as well as surveys regarding depression, sleep apnea, physical activity, social determinants of health, and health literacy will be conducted at the time of study enrollment and at 3 and 6 months of study participation.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

The Physicians' Foundation

Collaborator

Published Research Related to This Trial

Patients referred to health coaching by their physician were much more likely to enroll (21.0% vs 6.0%) and complete the program (8.5% vs 2.7%) compared to those identified through insurer outreach, highlighting the importance of physician involvement in patient engagement.

Both groups showed significant improvements in health risk levels after health coaching, indicating that health coaching can effectively reduce health risks regardless of the referral source, but physician referrals greatly enhance participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness. Parkinson, MD., Hammonds, T., Keyser, DJ., et al.[2021]

Health coaching delivered through videoconferencing (VC) resulted in significantly greater weight loss (8.23 kg) and increased physical activity (steps/day) compared to in-person coaching and a control group over a 12-week period, indicating its efficacy for adults with high BMI.

The VC group also showed a significant decrease in insulin resistance (HOMA-IR), suggesting that this method of health coaching can lead to improved metabolic health, while no significant changes were observed in glucose or HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Johnson, KE., Alencar, MK., Coakley, KE., et al.[2023]

In a study of Kaiser Permanente Northern California patients, 70% of those who completed two or more telephonic health coaching sessions reported satisfaction with the program, indicating a positive patient experience.

73% of participants who engaged in multiple sessions felt that the coaching helped them achieve their weight-related goals, highlighting the efficacy of telephonic coaching in promoting healthy lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011. Adams, SR., Goler, NC., Sanna, RS., et al.[2021]

Health coaching significantly reduced outpatient and total healthcare expenditures for high-risk participants, with estimated savings of $286 and $412 per person per month, respectively.

While health coaching did not impact emergency room costs, it did lead to a significant decrease in the probability of incurring inpatient expenditures, highlighting its potential effectiveness in managing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? Jonk, Y., Lawson, K., O'Connor, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775165/

Health and Wellness Coaching for 5-Year Projected ... We aimed to determine the efficacy of health and wellness coaching (HWC) for primary stroke and cardiovascular disease (CVD) prevention in ...

2. withpower.com withpower.com/trial/phase-hypertension-3-2025-6ae94

Health Coaching for Heart Disease · Info for Participants The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125027/

Clinical Effectiveness of Lifestyle Health Coaching Effectiveness of 3 models ... Effect of lifestyle health coaching on multiple cardiovascular disease risk factors: comparison with cardiac rehabilitation.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.123.321998

Life Course Cardiovascular Health: Risk Factors CVH measured at any point in life is strongly predictive of future cardiovascular disease, dementia, cancer, and mortality as well as a variety of other health ...

5. researchgate.net researchgate.net/publication/365056940_Effects_of_Health_Coaching_on_Cardiometabolic_Health_in_Middle-Aged_Adults_A_Systematic_Review_and_Meta-analysis

Effects of Health Coaching on Cardiometabolic ... at high risk of developing cardiometabolic diseases. 6. Moreover, these conditions are associated with serious. The ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/05/NCT05619705/Prot_SAP_000.pdf

Effectiveness of Health Coaching to Reduce ... increased risk of hypertension and cardiovascular disease (CVD) and 30% ... data extraction of height, weight, and comorbid conditions. We ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22238-w

A protection motivation theory-guided telehealth coaching ... Cardiometabolic diseases, which include cardiovascular disease, diabetes and chronic renal diseases, are the leading cause of global disability- ...

8. nature.com nature.com/articles/s44325-025-00083-5

Fine-tuning LLMs in behavioral psychology for scalable ... ... personalized health coaching, showing the potential for promoting long-term physical activity and reducing cardiovascular disease risk at scale.