Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06364644

Conditions

Type2diabetes

Heart Failure

Obesity

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Not accepted

Interventions

Community Champions

Homegrown Heroes

Study Details

Brief summary:

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

Study ID

NCT06364644

Start date

Jun 20, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Community Champions

Participants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach.

active comparator: Homegrown Heroes

Participants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention .

Interventions

Community Champions

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

Homegrown Heroes

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 outcome measure

  • Change in fitness as assessed by the 6 minute walk test [ Time Frame: Baseline and 6 month follow up ]

Central Contacts and Locations

Central contacts

Chiadi Ndumele, MD, PhD

4105022319cndumel2@jhmi.edu

Perri Carroll, MPH

4436927272pcarro13@jhmi.edu

Locations

Johns Hopkins Center for Health Equity

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Perri Carroll, MPH

443-692-7272pcarro13@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Behavioral Intervention
  • Diabetes
  • Heart Failure
  • Exercise
  • Obesity
  • Health Equity
  • Low Socioeconomic Status

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-15.