Improving heart health for low-income individuals with diabetes and obesity
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
This study is testing whether a 6-month program that includes training, exercise help, and community support can improve heart health for low-income people with diabetes and obesity compared to regular education and exercise access.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06364644 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a 6-month multilevel intervention designed for individuals with low socioeconomic status, type 2 diabetes, obesity, and early signs of heart dysfunction. Participants will receive problem-solving training, exercise support, and assistance from community health workers to enhance their self-management skills and improve health outcomes. The study will randomly assign 402 individuals from Baltimore City and Hagerstown, Maryland, to either the intervention group or a control group receiving standard education and access to exercise facilities. The goal is to determine if the comprehensive support leads to better management of their conditions compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 70 with low socioeconomic status, type 2 diabetes, and obesity living in Baltimore City or Hagerstown, Maryland.
Not a fit: Patients with uncontrolled diabetes or blood pressure, prevalent heart failure, or serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for patients with diabetes and obesity, reducing their risk of heart failure.
How similar studies have performed: Other studies have shown promise in using community health workers and behavioral interventions to improve health outcomes in similar populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Center for Health Equity — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University Comstock Center — Hagerstown, Maryland, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Chiadi Ndumele, MD, PhD — Johns Hopkins School of Medicine
- Study coordinator: Chiadi Ndumele, MD, PhD
- Email: cndumel2@jhmi.edu
- Phone: 4105022319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.