Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
UNLOAD-HF
2 other identifiers
interventional
210
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 15, 2024
CompletedStudy Start
First participant enrolled
June 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 27, 2026
March 1, 2026
1.2 years
March 27, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fitness as assessed by the 6 minute walk test
Total distance walked in the 6 minutes walk test in meters
Baseline and 6 month follow up
Secondary Outcomes (17)
Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)
Baseline and 6 month follow up
Change in hemoglobin A1c
Baseline and 6 month follow up
Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.
Baseline, 6 month follow up, 12 month follow up
Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)
Baseline, 6 month follow up, 12 month follow up
Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test
Baseline, 6 month follow up, 12 month follow up
- +12 more secondary outcomes
Study Arms (2)
Community Champions
EXPERIMENTALParticipants 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.
Homegrown Heroes
ACTIVE COMPARATORParticipants 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
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Center for Health Equity
Baltimore, Maryland, 21205, United States
Johns Hopkins University Comstock Center
Hagerstown, Maryland, 21740, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiadi Ndumele, MD, PhD
Johns Hopkins School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm .
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 15, 2024
Study Start
June 20, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share