Preventative Screening and Health Coaching in a Food Insecure Population

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRush University Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

10 - Year Atherosclerotic Cardiovascular Disease Risk Score

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).

Time frame
From enrollment to the end of study participation at 6 months.

Secondary outcomes

1

Depression - Patient Health Questionnaire - 2 (PHQ2)

During each in-person screening - initial screening, 3, and 6 month rescreening - patients will be screened for depression using the Patient Health Questionnaire - 2 (PHQ2). Patients who screen positive for depressive symptoms will be referred to on-site mental health specialists for additional resources and care.

Time frame
From enrollment to the end of study participation at 6 months.
2

Sleep Apnea - STOP-BANG

Patients will be screened for sleep apnea at each in-person event - including the initial screening, 3, and 6 month rescreening - using the STOP-BANG survey.

Time frame
From enrollment to the end of study participation at 6 months.
3

Point-of-care Hemoglobin A1c

Patients will undergo a fingerstick to analyze hemoglobin A1c levels using the Abbott Afinion 2 Analyzer. A1c will be measured at the initial screening, 3, and 6 month rescreening.

Time frame
From enrollment to the end of study participation at 6 months.
4

Point-of-care Blood Lipid Level

Patients will undergo a fingerstick to measure a point-of-care blood lipid panel using the PTS Diagnostics CardioCheck Plus Analyzer. Measured data will include: total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). Lipid levels will be measured at the initial screening, 3, and 6 month rescreening.

Time frame
From enrollment to the end of study participation at 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

The Physicians Foundation

Collaborator