RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT06364644

Registry updated: 2026-10-14

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Description

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.

Interventions

Community Champions (Behavioral)
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Homegrown Heroes (Behavioral)
Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.

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

Conditions

Type2diabetes Heart Failure Obesity

Locations

Johns Hopkins Center for Health Equity — Baltimore, Maryland, United States
Johns Hopkins University Comstock Center — Hagerstown, Maryland, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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