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Community champions take on heart failure risk in Low-Income communities

NCT ID NCT06364644

Disease control Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study tests whether a 6-month program of problem-solving training, community health worker support, and exercise coaching at a YMCA can improve fitness and heart health in 210 adults with type 2 diabetes, obesity, and low income. Participants are compared to those who receive only educational materials and a gym membership. The goal is to see if the extra support leads to better walking ability and lower heart strain.

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 support, problem-solving training, and exercise coaching
What this could lead to
If successful, this could show that a community-based program helps people with diabetes and obesity improve their fitness and reduce heart failure risk.
What could go wrong
This is a small, early-stage study (210 participants) focused on short-term changes. Results may not apply to other groups or lead to lasting benefits.

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 156 people

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

Started

Jun 2025

Expected to finish

Mar 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

30 to 70 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 Criteria: * Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County * Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \[\>75th percentile for the state of Maryland\] plus low income) * Type 2 diabetes * Obesity (BMI≥30 kg/m\^2) Exclusion Criteria: * Age \< 30 or \>70 years * Prevalent heart failure * Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%) * Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications) * Known coronary artery disease (unless \< 50% stenosis by angiography) * Moderate or severe valvular heart disease * Serious medical conditions limiting life expectancy or requiring active management * Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+). * Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week * End-stage renal disease * Current participation in another behavior change program * Active alcohol or substance abuse disorder * Already engaging in regular exercise with more than 60 minutes of moderate \[3-6 METS\] to vigorous \[\>6 METS\] physical activity per week * Active pregnancy * Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Motor Activity Obesity obesity disorder type 2 diabetes mellitus heart failure prevention target

As listed by the trial registrant

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

Heart failure Obesity TYPE2DIABETES

How to take part

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

  1. The places running it

    2 sites. 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

  • Johns Hopkins Center for Health Equity

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Johns Hopkins University Comstock Center

    NOT_YET_RECRUITING

    Hagerstown, Maryland, 21740, United States

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