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Could a health coach cut heart attack risk in Food-Insecure communities?

NCT ID NCT06907524

Prevention Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study tests whether regular, personalized health coaching—delivered virtually and during community screenings—can reduce the 10-year risk of heart attack or stroke in adults aged 40-75 who have at least one cardiometabolic risk factor like high blood pressure, high cholesterol, or diabetes. Participants will receive coaching on diet, exercise, and medication management over six months, with screenings at the start, 3 months, and 6 months. The goal is to see if this approach can lower cardiovascular risk and improve access to healthcare in an underserved, food-insecure population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Longitudinal, individualized health coaching focused on lifestyle modification (diet, exercise, weight, blood pressure, diabetes control)
What this could lead to
If effective, this approach could offer a low-cost, scalable way to reduce heart disease and diabetes risk in underserved communities, potentially improving health equity.
What could go wrong
This is a small, early-stage study without a control group, so results may not be conclusive. Success depends on participants' adherence to coaching and lifestyle changes, which can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diabetes mellitus hyperlipidemia hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiometabolic diseases Cardiovascular disease prevention Cardiovascular risk factor Cardiovascular risk score Diabetes Health coaching Hyperlipidemia Hypertension Lifestyle modification

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

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