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Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
Who can join
Ages 30 to 70 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Community Champions (behavioral)
- Homegrown Heroes (behavioral)
Sponsor: Johns Hopkins University · Participants: 156 · Started: Jun 20, 2025
Contact the study team
- Chiadi Ndumele, MD, PhD · Phone: 4105022319
- Perri Carroll, MPH · Phone: 4436927272
Official record on ClinicalTrials.gov — NCT06364644
Locations in the U.S.
| Maryland | Johns Hopkins Center for Health Equity, Baltimore Johns Hopkins University Comstock Center, Hagerstown (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.