Recruiting

Virtual Health Coaching

Sponsor:

Rush University Medical Center

Code:

NCT06907524

Conditions

Cardiovascular Disease Prevention

Cardiometabolic Diseases

Cardiovascular Risk Factor

Cardiovascular Risk Score

Hypertension

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Longitudinal, Individualized Health Coaching

Study Details

Brief summary:

The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are:

  • Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke?
  • Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes?
  • Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare?

Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors.

Participants will:

  • Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6.
  • Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare
  • Keep a log of their blood pressure

Conditions

Cardiovascular Disease Prevention

Cardiometabolic Diseases

Cardiovascular Risk Factor

Cardiovascular Risk Score

Hypertension

Study ID

NCT06907524

Start date

Mar 1, 2025

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion:

  • 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
  • English or Spanish speaking
  • Age 40-75 years old
  • At least 1 cardiometabolic risk factor at suboptimal level, defined as one or more of the following at initial screening:
  • Systolic BP greater than 130mmHg and/or diastolic BP greater than 80mmHg.
  • Body mass index (BMI) greater than 30 〖kg/m〗\^2
  • Total cholesterol greater than 200 mg/dL
  • Triglycerides greater than 150 mg/dL
  • Low density lipoprotein (LDL) greater than 130 mg/dL
  • High density lipoprotein (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:

  • Adults unable to provide informed consent or unwilling to participate for study duration
  • Speaks language other than English or Spanish
  • Younger than 40 years old or older than 75 years old
  • All cardiometabolic risk factors at optimal levels
  • No telehealth compatible device
  • Pregnant patients

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Longitudinal, Individualized Health Coaching

During in-person events and screening - occurring at the initial screening, 3, and 6 months - patients will receive individualized health coaching by on-site physicians and nurse practitioners specializing in lifestyle medicine. Patients will receive virtual 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. Interventions will include but not limited to: changes in diet, exercise, smoking, and drinking status. 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 the first month and monthly for the following 2 months. Sessions will last approximately 15 minutes in length.

Primary outcome measure

  • 10 - Year Atherosclerotic Cardiovascular Disease Risk Score [ Time Frame: From enrollment to the end of study participation at 6 months. ]

Central Contacts and Locations

Central contacts

Daniel Luger, MD

\(708) 660-2328daniel_luger@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Daniel Luger, MD

(312) 942-5020daniel_luger@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Cardiovascular Disease Prevention
  • Cardiometabolic Disease Screening
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Lifestyle Modification
  • Health Coaching
  • Cardiovascular Risk Score
  • Atherosclerotic Cardiovascular Disease Risk Score
  • Cardiovascular Risk Factor
  • Cardiometabolic Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-24.