[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06364644":3,"trial-entities:NCT06364644":179,"trial-summary:NCT06364644":183},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":54,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":112,"eligibility_criteria":113,"std_ages":136,"locations":139,"central_contacts":166,"overall_officials":173,"references":177,"see_also_links":178},"NCT06364644","IRB00336599","Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure","Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)","RECRUITING","2027-03","2026-07","2026-07-15","2025-06-20","Johns Hopkins University","OTHER",true,"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.","This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:\n\n1. Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.\n2. Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and\u002For home visits at least monthly, offering assistance in following areas:\n\n   * Reinforcing patient education about disease self-management\n   * Helping patients access care and addressing barriers to care and treatment\n   * Serving as facilitators and navigators to clinical care, social services, and other community resources\n   * Providing encouragement and support to engage, activate, and empower patients and their support systems\n3. Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).",[19,20,21],"Type2diabetes","Heart Failure","Obesity",[23,24,20,25,21,26,27],"Behavioral Intervention","Diabetes","Exercise","Health Equity","Low Socioeconomic Status","INTERVENTIONAL","PREVENTION",[31],"NA",{"count":33,"type":34},156,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BEHAVIORAL","Community Champions","The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.",[38],[42],"Multi-level intervention",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Homegrown Heroes","Monthly newsletters\u002Fvideos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.",[44],[48],"Education plus access to community exercise facility",[50],{"measure":51,"description":52,"timeFrame":53},"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",[55,58,61,65,68,71,74,78,81,84,87,91,94,97,100,103,106],{"measure":56,"description":57,"timeFrame":53},"Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)","Percent change from baseline in hs-cTnT",{"measure":59,"description":60,"timeFrame":53},"Change in hemoglobin A1c","Absolute change from baseline in hemoglobin A1c",{"measure":62,"description":63,"timeFrame":64},"Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.","The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive\u002FCareless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation\u002FOrientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124.","Baseline, 6 month follow up, 12 month follow up",{"measure":66,"description":67,"timeFrame":64},"Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)","The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.",{"measure":69,"description":70,"timeFrame":64},"Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test","The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease.",{"measure":72,"description":73,"timeFrame":64},"Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)","The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes.\n\nThe MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity.",{"measure":75,"description":76,"timeFrame":77},"Change in weight (kgs)","Change from baseline in weight (kgs)","Baseline and 6 month follow-up",{"measure":79,"description":80,"timeFrame":77},"Change in BMI","Change from baseline in BMI (Kg\u002Fm\\^2).",{"measure":82,"description":83,"timeFrame":53},"Change in hip and waist circumference (centimeters)","Change from baseline in hip and waist circumference (centimeters)",{"measure":85,"description":86,"timeFrame":53},"Change in Metabolic Syndrome Severity Z score","Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity.",{"measure":88,"description":89,"timeFrame":90},"Change in self-management as assessed by the Patient Activation Measure (PAM-13).","The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action.","Baseline, 6 month follow up,12 month follow up",{"measure":92,"description":93,"timeFrame":90},"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","The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes.",{"measure":95,"description":96,"timeFrame":53},"Change in blood pressure (systolic and diastolic (mmHg))","changes in blood pressure from baseline",{"measure":98,"description":99,"timeFrame":53},"Change in cardiac biomarker, gal-3","Percent change from baseline in gal-3",{"measure":101,"description":102,"timeFrame":53},"Change in cardiac biomarkers, NT-proBNP","Percent change from baseline in NT-proBNP",{"measure":104,"description":105,"timeFrame":53},"Change in post-walk Borg dyspnea scale","Changes in post-walk Borg dyspnea scale which ranges from 0 (\"no shortness of breath\") to 10 (\"worst possible shortness of breath\"); higher score worse breathing difficulty. Measured in a subset of the population.",{"measure":107,"description":108,"timeFrame":53},"Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)","Change in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test in a subset of the population.","ALL","30 Years","70 Years",false,{"inclusion":114,"exclusion":119,"raw_text":135},[115,116,117,118],"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\u002Fm\\^2)",[120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Age \\\u003C 30 or \\>70 years","Prevalent heart failure","Uncontrolled glycemia (blood glucose \\\u003C60 mg\u002Fd or ≥ 300 mg\u002Fdl 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 \\\u003C 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\u002Fprocedure 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","Inclusion Criteria:\n\n* 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\n* Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \\[\\>75th percentile for the state of Maryland\\] plus low income)\n* Type 2 diabetes\n* Obesity (BMI≥30 kg\u002Fm\\^2)\n\nExclusion Criteria:\n\n* Age \\\u003C 30 or \\>70 years\n* Prevalent heart failure\n* Uncontrolled glycemia (blood glucose \\\u003C60 mg\u002Fd or ≥ 300 mg\u002Fdl or most recent hemoglobin A1c ≥11%)\n* Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)\n* Known coronary artery disease (unless \\\u003C 50% stenosis by angiography)\n* Moderate or severe valvular heart disease\n* Serious medical conditions limiting life expectancy or requiring active management\n* Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).\n* Any condition or planned surgery\u002Fprocedure precluding exercise for ≥ 150 minutes per week\n* End-stage renal disease\n* Current participation in another behavior change program\n* Active alcohol or substance abuse disorder\n* Already engaging in regular exercise with more than 60 minutes of moderate \\[3-6 METS\\] to vigorous \\[\\>6 METS\\] physical activity per week\n* Active pregnancy\n* Evidence of ischemia, dangerous arrhythmia, or other clinical instability on baseline exercise stress test",[137,138],"ADULT","OLDER_ADULT",[140,155],{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":145,"contacts":146,"geoPoint":152},"Johns Hopkins Center for Health Equity","Baltimore","Maryland","21205","United States",[147],{"name":148,"role":149,"phone":150,"email":151},"Perri Carroll, MPH","CONTACT","443-692-7272","pcarro13@jhmi.edu",{"lat":153,"lon":154},39.29038,-76.61219,{"facility":156,"status":157,"city":158,"state":143,"zip":159,"country":145,"contacts":160,"geoPoint":163},"Johns Hopkins University Comstock Center","NOT_YET_RECRUITING","Hagerstown","21740",[161],{"name":162,"role":149},"Melissa Minotti, MPH, RPSGT, CCRC",{"lat":164,"lon":165},39.64176,-77.71999,[167,171],{"name":168,"role":149,"phone":169,"email":170},"Chiadi Ndumele, MD, PhD","4105022319","cndumel2@jhmi.edu",{"name":148,"role":149,"phone":172,"email":151},"4436927272",[174],{"name":168,"affiliation":175,"role":176},"Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":180,"biomarkers":182},[21,181],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":184,"prompt_version":193},{"design":185,"status":186,"heading":6,"summary":187,"follow_up":188,"word_count":189,"commitments":190,"compensation":191,"drugs_mentioned":192},"This is an interventional study with a planned enrollment of 156 participants. It is a randomized controlled trial, meaning participants will be assigned to one of two groups by chance.","completed","This study is looking for people aged 30-70 who live in Baltimore City or Washington County, Maryland, have type 2 diabetes, obesity, and low socioeconomic status. You should also show early signs of heart problems, even if you haven't been diagnosed with heart failure yet. The study wants to see if a 6-month program called \"Community Champions\" is better at improving your fitness than receiving newsletters and a YMCA membership (called \"Homegrown Heroes\"). The \"Community Champions\" program includes problem-solving training, support from community health workers, and exercise help from health coaches at the YMCA. We will measure your fitness using a 6-minute walk test at the beginning and after 6 months to see if the programs help.","Participants will be followed for 6 months after the intervention begins.",117,"Participants will engage in a 6-month intervention, which may include biweekly problem-solving training, support from community health workers, and exercise support. Fitness will be assessed at the beginning and after 6 months.","Not stated in the trial record.",[38,44],"v2"]