Preventative Screening and Health Coaching in a Food Insecure Population

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06907524
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Longitudinal, Individualized Health Coaching — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Apr 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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