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

Recruiting now · Not applicable

Conditions studied: Type2diabetes, Heart Failure, Obesity

In brief

This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.

Key facts

Study ID

NCT06364644

Run by

Johns Hopkins University

People needed

156

Starts

2025-06-20

Expected to finish

2027-03-01

Last updated by the study team

2026-07-15

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Center for Health Equity — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins University Comstock Center — Hagerstown, Maryland, United States

Full record on ClinicalTrials.gov

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