Improving heart health for low-income individuals with diabetes and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.