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

Launched by JOHNS HOPKINS UNIVERSITY · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial focuses on finding out if a special program can help people with low income who have type 2 diabetes, obesity, and early signs of heart problems. The program lasts for six months and includes problem-solving training, exercise classes, and support from community health workers. Researchers want to see if this approach is better at improving health than just providing information and access to a community gym.

To participate in the study, you need to live in Baltimore or Hagerstown, be an adult with low socioeconomic status (meaning you might have financial challenges), have type 2 diabetes, and be obese (with a body mass index of 30 or higher). You should also have early signs of heart issues based on specific medical tests. If you meet these criteria, you can expect to join a supportive program designed to help improve your health over six months. Keep in mind that there are some health conditions that would prevent you from participating, so it's important to check if you qualify.

Gender

ALL

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+).
• • Weight loss of ≥ 5% in the past year or current use of weight loss medications
• • 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