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

Description

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.

Conditions

Type2diabetes, Heart Failure, Obesity

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Study Overview

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Study Details

Study overview

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.

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)

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

Condition
Type2diabetes
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Center for Health Equity, Baltimore, Maryland, United States, 21205

Hagerstown

Johns Hopkins University Comstock Center, Hagerstown, Maryland, United States, 21740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Meritus Medical Center (MMC) or Family Healthcare of Hagerstown who live in Hagerstown.
  • * 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)
  • * Evidence of cardiac dysfunction (by echocardiogram or elevated NT-proBNP \[≥125 pg/ml\])
  • * 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

Ages Eligible for Study

30 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Chiadi Ndumele, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

2027-06-30