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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06364644
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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 .

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Health EquityBaltimoreMaryland21205
Perri Carroll, MPH
[email protected]
443-692-7272
Johns Hopkins University Comstock CenterHagerstownMaryland21740
Melissa Minotti, MPH, RPSGT, CCRC

Find similar trials in Baltimore, MD

By condition
Heart failureObesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins Center for Health Equity· Baltimore, MDJohns Hopkins University Comstock Center· Hagerstown, MD

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