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

Recruiting

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

Sponsor: Johns Hopkins University · Participants: 156 · Started: Jun 20, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06364644

Locations in the U.S.

MarylandJohns 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.