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Can churches help close the heart health gap? new study tests community approach

NCT ID NCT06065098

Disease control Sponsor: Tulane University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a church-based program led by community health workers can help Black adults in Louisiana lower their risk of heart disease, high blood pressure, diabetes, and high cholesterol. About 812 participants from local churches will receive either a health worker-led program or group education sessions. The goal is to see which approach works better over 18 months.

What this could mean

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

Active substance
community health worker-led lifestyle and medical management program
What this could lead to
If successful, this could show that church-based community health worker programs effectively reduce heart disease risk and racial health disparities.
What could go wrong
This is a behavioral intervention study, not a drug trial. Results depend on participant adherence and may not apply to other communities or settings.

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

812 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Aug 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 years and older

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 Criteria: * Men or women aged ≥40 years * Community members associated with the participating churches (church members and their families and friends) * Individuals with three or more CVD risk factors (out of seven): * Current smoker * Overweight or obese (BMI ≥25 kg/m2) * Insufficient physical activity (\<150 minutes/week moderate intensity or \<75 minutes/week vigorous intensity) * Healthy diet score of \<4 components * Total cholesterol ≥200 mg/dL * Blood pressure ≥130/80 mmHg * Fasting plasma glucose ≥100 mg/dL * Willing and able to participate in the intervention Exclusion Criteria: * No prior hospitalization in the last 3 months for chronic heart failure or heart attack. * No current diagnosis of cancer requiring chemotherapy or radiation therapy * No stage-5 chronic kidney disease requiring chronic dialysis, or transplant. * Not pregnant or planning to become pregnant in the next 18 months. * No plans to move out of the New Orleans metropolitan area during the next year.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diabetes mellitus Hypercholesterolemia hyperlipidemia hypertensive disorder

As listed by the trial registrant

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

Cardiovascular diseases Diabetes Hypercholesterolemia Hypertension

Contacts and locations

Locations

  • Tulane University

    New Orleans, Louisiana, 70112, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.