Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
Recruiting · NCT06364644 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
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What this trial is about
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.
Who can take part
Age range
30 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Johns Hopkins Center for Health Equity - Baltimore, Maryland, United States
- Johns Hopkins University Comstock Center - Hagerstown, Maryland, United States