NCT06907524 · Rush University Medical Center
Preventative Screening and Health Coaching in a Food Insecure Population
(HEALTHCOACH)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
10 - Year Atherosclerotic Cardiovascular Disease Risk Score
Time frame: From enrollment to the end of study participation at 6 months.
Study data collected during in-person screening - occuring at the initial screening, 3 and 6 month rescreening - will be utilized to calculate the patient's 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk via the MD+ Calc ASCVD risk calculator from the American Heart Association (AHA)/American College of Cardiology (ACC).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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 criteria
- 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
Where
- Chicago, Illinois
Collaborators
The Physicians Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations