NCT06364644Recruiting
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)
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 27 Mar 2024
- Start date
- 20 Jun 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06364644
What you commit to
- Study type: Interventional
- Planned participants: 156
- From 20 Jun 2025 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)
Other illness
- Prevalent heart failure
- 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
- Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
- End-stage renal disease
- Active alcohol or substance abuse disorder
- Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test
Lab values
- Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%)
Age
- Age \< 30 or \>70 years
Other
- Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).
- Current participation in another behavior change program
- 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
Who the study is looking for
- 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)
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Center for Health Equity Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins University Comstock Center Coordinator of this site? Confirm its status | Hagerstown | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.