Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

This study is looking for people aged 30-70 who live in Baltimore City or Washington County, Maryland, have type 2 diabetes, obesity, and low socioeconomic status. You should also show early signs of heart problems, even if you haven't been diagnosed with heart failure yet. The study wants to see if a 6-month program called "Community Champions" is better at improving your fitness than receiving newsletters and a YMCA membership (called "Homegrown Heroes"). The "Community Champions" program includes problem-solving training, support from community health workers, and exercise help from health coaches at the YMCA. We will measure your fitness using a 6-minute walk test at the beginning and after 6 months to see if the programs help.

Study design
This is an interventional study with a planned enrollment of 156 participants. It is a randomized controlled trial, meaning participants will be assigned to one of two groups by chance.
What's involved
Participants will engage in a 6-month intervention, which may include biweekly problem-solving training, support from community health workers, and exercise support. Fitness will be assessed at the beginning and after 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the intervention begins.

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NCT06364644

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

Recruiting
NAAges 30–70InterventionalPrevention
Johns Hopkins University
~156 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Community ChampionsHomegrown Heroes

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fitness as assessed by the 6 minute walk test
Measured over Baseline and 6 month follow up
Type2diabetes
Heart Failure
Obesity
2 sites across 1 states
Maryland2
  • Chiadi Ndumele, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

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Eligibility criteria

Inclusion

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

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
  • Change in fitness as assessed by the 6 minute walk testBaseline and 6 month follow up

    Total distance walked in the 6 minutes walk test in meters