Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06364644

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionType2diabetes, Heart Failure, Obesity

Full registry 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

Treatments and study arms

Community Champions

Behavioral

The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.

Homegrown Heroes

Behavioral

Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.

Primary outcomes

Change in fitness as assessed by the 6 minute walk testBaseline and 6 month follow up

Total distance walked in the 6 minutes walk test in meters

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Johns Hopkins Center for Health Equity🇺🇸 Baltimore, Maryland, United States
Perri Carroll, MPHContact
Johns Hopkins University Comstock Center🇺🇸 Hagerstown, Maryland, United States
Melissa Minotti, MPH, RPSGT, CCRCContact