protocolSection identificationModule nctId: NCT06364644, orgStudyIdInfo id: IRB00336599, secondaryIdInfos id: 1P50MD017348-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1P50MD017348-01, briefTitle: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure, acronym: UNLOAD-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: 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., conditionsModule conditions: Type2diabetes, conditions: Heart Failure, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The design of the study is a randomized 2:1 parallel-arm clinical trial., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm ., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 402, type: ESTIMATED, armsInterventionsModule interventions name: Community Champions, interventions name: Homegrown Heroes, outcomesModule primaryOutcomes measure: Change in cardiorespiratory fitness, secondaryOutcomes measure: Change in cardiac biomarker, hs-cTnT, secondaryOutcomes measure: Change in hemoglobin A1c, secondaryOutcomes measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales., secondaryOutcomes measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA), secondaryOutcomes measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test, secondaryOutcomes measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ), secondaryOutcomes measure: Change in weight (kgs), secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Change in hip and waist circumference (centimeters), secondaryOutcomes measure: Change in Metabolic Syndrome Severity Z score, secondaryOutcomes measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13)., secondaryOutcomes measure: Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10, secondaryOutcomes measure: Change in blood pressure (systolic and diastolic (mmHg)), secondaryOutcomes measure: Change in cardiac biomarker, gal-3, secondaryOutcomes measure: Change in cardiac biomarkers, NT-proBNP, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False