Support Your Heart for Cardiovascular Health

(SYH Trial)

MN
CO
Overseen ByCarmen Ortega-Santos, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: George Washington University
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 phone-based health coaching, called "Support Your Heart," can improve heart health and reduce loneliness and stress. Participants will receive weekly calls from a health coach for 12 weeks to discuss healthy habits and track progress. The trial targets individuals aged 18-39 in the Washington DC area with at least two heart health risk factors, such as insufficient sleep or high blood pressure. By evaluating the effectiveness of this approach, researchers aim to address major health issues affecting daily life. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health and well-being.

Do I have to stop taking my current medications for the trial?

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 this protocol is safe for participants?

Research has shown that the "Support Your Heart" program improves heart health through lifestyle changes such as healthier eating and increased exercise. These changes are safe and can help prevent heart disease. The American Heart Association emphasizes the importance of these habits for maintaining heart health.

The program includes weekly phone calls from a health coach who guides participants. This approach is generally well-received because it combines learning with personal support. No reports of serious side effects have emerged from these types of programs, making it a safe choice for improving heart health.12345

Why are researchers excited about this trial?

The "Support Your Heart" treatment is unique because it offers a fresh approach to cardiovascular health through a 12-week telephone-based health coaching program. Unlike traditional treatments that often rely on medication or invasive procedures, this method focuses on personalized lifestyle coaching, which could empower patients to make sustainable health changes. Researchers are excited about this treatment because it uses an accessible, non-invasive technique that could potentially improve heart health without the side effects associated with medication. Additionally, by incorporating ongoing support and motivation, it aims to promote long-term heart health, which is a shift from the typical focus on immediate medical interventions.

What evidence suggests that the "Support Your Heart" phone-based protocol is effective for cardiovascular health?

Research has shown that strong social support can lower the risk of heart disease and stroke. People with weak social connections face a 30% higher likelihood of developing these conditions. Studies also indicate that healthy lifestyle changes, such as improving diet and exercise, can protect the heart and reduce risks like high blood pressure and cholesterol. In this trial, the "Support Your Heart" program provides phone-based health coaching to help participants make these changes and enhance their heart health. This method may also reduce feelings of loneliness and stress, which are crucial for heart health.26789

Who Is on the Research Team?

MN

Melissa Napolitano, PhD

Principal Investigator

GW

Are You a Good Fit for This Trial?

This trial is for adults aged 18-39 who have at least two risk factors for heart disease, such as poor sleep, low physical activity, tobacco use, high BMI, high cholesterol or blood pressure, high blood sugar (HbA1c), or an unhealthy diet.

Inclusion Criteria

At least two risk factors for cardiovascular disease including not enough sleep, insufficient physical activity, tobacco and nicotine product use, elevated body mass index, poor diet, high cholesterol, high blood pressure, and/or elevated HbA1c
Living in Washington DC area
I am between 18 and 39 years old.

Exclusion Criteria

I am able to follow study instructions and am not in another similar research program.
Plan to become pregnant during study duration
Psychiatric hospitalization, psychosis, or suicide attempt within last 12 months
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person), online questionnaire

Baseline Assessment

Participants complete a baseline survey before beginning the intervention

1 week

Treatment

Participants receive weekly phone calls from a health coach to review key concepts and provide feedback

12 weeks
12 calls (phone)

Follow-up

Follow-ups conducted to assess participant progress and satisfaction

12 weeks
3 follow-up assessments at 4, 8, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Support Your Heart

Trial Overview

The study tests a phone-based health coaching program called 'Support Your Heart.' Participants get weekly calls over 12 weeks to help improve heart health habits and reduce stress and loneliness. The focus is on feasibility and participant satisfaction.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Support Your HeartExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Implementation of Evidence-Based Behavioral ...

Extending cardiovascular disease prevention beyond health care settings is needed to improve population health and to advance health equity.

Impact of Social Support on Cardiovascular Risk Prediction ...

People with poor social health were 30% more likely to develop coronary heart disease (CHD) and stroke episodes, according to a systematic review published in ...

Strategies to prevent heart disease

Eat a heart-healthy diet. A healthy diet can help protect the heart, improve blood pressure and cholesterol, and lower the risk of type 2 diabetes.

Effectiveness of coronary heart disease peer support ...

Peer support interventions for people with CHD may be used to improve self-management and self-efficacy and reduce readmission risk.

Global Responses to Prevent, Manage, and Control ...

Provisional mortality data for 2021 indicate that even during the COVID-19 pandemic, heart disease and stroke remained the first and the fifth ...

Life's Essential 8

Life's Essential 8 are the key measures for improving and maintaining cardiovascular health, as defined by the American Heart Association.

Towards Optimal Cardiovascular Health - PMC - NIH

Herein, this review covers various preventive measures, including dietary interventions, exercise, controlling HTN, DM, cholesterol, and weight ...

Surveillance and Evaluation Data Resource Guide

An at-a-glance compilation of data sources useful for heart disease and stroke prevention programs conducting policy or data surveillance and/or evaluation.

Shared Decision-Making and Cardiovascular Health

This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes.