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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 6-month program of problem-solving training, exercise training, and support from community health workers. It compares this program with education and access to a community exercise center for people with low income, type 2 diabetes, obesity, and early heart function problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Get care at Johns Hopkins Medicine and live in Baltimore City, or get care at Johns Hopkins Community Physicians Hagerstown or Family Healthcare of Hagerstown and live in Washington County.
  • Have low income and live in an area with a hardship score above the 75th percentile in Maryland.
  • Have type 2 diabetes.
  • Have obesity, with a body mass index (BMI, a measure of weight compared with height) of 30 or higher.

Who can't join

  • Are younger than 30 or older than 70.
  • Have heart failure, moderate or severe heart valve disease, or known disease in the heart's arteries unless an artery scan shows less than 50% narrowing. Also excluded: an exercise stress test showing poor blood flow to the heart, a dangerous heartbeat, or other signs that your condition is not stable.
  • Have blood sugar below 60 or at least 300 mg/dL, or a latest A1c of 11% or higher. A1c measures average blood sugar over time.
  • Have blood pressure with a top number of 160 or higher or a bottom number of 100 or higher, with or without medicine.
  • Have kidney failure at its final stage, or another serious illness that may shorten your life or needs active care.
  • Cannot safely do moderate exercise based on an activity readiness questionnaire, or have a condition or planned procedure that prevents 150 minutes of exercise each week. Also excluded: already doing more than 60 minutes of moderate to hard exercise each week.
  • Are in another behavior-change program or have an active alcohol or drug abuse disorder.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

MD