Preventative Screening and Health Coaching in a Food Insecure Population

NCT06907524 | Not Yet Recruiting

• 2 other identifiers: 241125092024DOH05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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; Hyperlipidemia; Diabetes; Lifestyle Modification; Health Coaching

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

Outcome Measures

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).

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

Secondary Outcomes (9)

• Depression - Patient Health Questionnaire - 2 (PHQ2)

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

• Sleep Apnea - STOP-BANG

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

• Point-of-care Hemoglobin A1c

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

• Point-of-care Blood Lipid Level

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

• Blood Pressure

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

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Longitudinal, Individualized Health Coaching

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Blood Pressure (BP):
• Systolic BP greater than 130mmHg and/or diastolic BP greater than 80mmHg. Obesity: body mass index (BMI) greater than 30 〖kg/m〗\^2
• Dyslipidemia:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• The Physicians' Foundation: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (15)

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  PMID: 12709466 BACKGROUND

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  PMID: 26732187 BACKGROUND

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  PMID: 32389532 BACKGROUND

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  PMID: 38733959 BACKGROUND

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  PMID: 33772668 BACKGROUND

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MeSH Terms

Conditions

Hypertension; Hyperlipidemias; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Daniel Luger, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Luger, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine, Rush Oak Park, Cardiovascular Prevention and Clinical Lipidology, Division of Cardiology

Model Details: The described study is a longitudinal study directed at investigating the role of virtual health coaching on mitigation of cardiometabolic disease risk. Patients will be recruited from existing community screening events organized by the Cardiometabolic Health Initiative (CHI). CHI is a mobile screening clinic that provides comprehensive cardiometabolic health screenings to clients of food pantries on the west side of Chicago, Illinois. Eligible patients will be recruited and will receive individualized, virtual health coaching directed at lifestyle modification in order to improve cardiometabolic health.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

US (1)