Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
All Genders
NCT06364644

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

Led by Johns Hopkins University · Updated on 2026-03-27

210

Participants Needed

2

Research Sites

88 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults from Johns Hopkins Medicine (JHM) living in Baltimore City or from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown living in Washington County
  • Low socioeconomic status defined by a high Area Deprivation Index (>75th percentile for Maryland) plus low income
  • Diagnosis of type 2 diabetes
  • Obesity with body mass index (BMI) of 30 kg/m2 or higher
Not Eligible

You will not qualify if you...

  • Age younger than 30 years or older than 70 years
  • Diagnosed heart failure
  • Uncontrolled blood sugar (blood glucose below 60 mg/dL or above or equal to 300 mg/dL, or hemoglobin A1c 11% or higher)
  • Uncontrolled blood pressure (systolic 160 mm Hg or higher or diastolic 100 mm Hg or higher, regardless of medications)
  • Known coronary artery disease unless less than 50% narrowing by angiography
  • Moderate or severe heart valve disease
  • Serious medical conditions that limit life expectancy or need active treatment
  • Unable to safely do moderate intensity exercise based on Physical Activity Readiness Questionnaire Plus (PAR-Q+)
  • Any condition or planned surgery preventing exercise for at least 150 minutes per week
  • End-stage kidney disease
  • Currently participating in another behavior change program
  • Active alcohol or substance abuse disorder
  • Already exercising regularly more than 60 minutes per week at moderate to vigorous levels
  • Active pregnancy
  • Signs of heart ischemia, dangerous arrhythmia, or other instability on baseline exercise stress test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Johns Hopkins Center for Health Equity

Baltimore, Maryland, United States, 21205

Actively Recruiting

2

Johns Hopkins University Comstock Center

Hagerstown, Maryland, United States, 21740

Not Yet Recruiting

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Research Team

C

Chiadi Ndumele, MD, PhD

CONTACT

P

Perri Carroll, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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