[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07034352":3,"trial-entities:NCT07034352":137,"trial-summary:NCT07034352":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":47,"secondary_outcomes":52,"sex":65,"minimum_age":66,"maximum_age":16,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":74,"locations":77,"central_contacts":126,"overall_officials":131,"references":135,"see_also_links":136},"NCT07034352","HUM00256551","Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings","RECRUITING","2026-12","2026-07","2026-07-16","2025-06-20","University of Michigan","OTHER",false,"The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular health (CVH), including physical, mental, and social health outcomes, among adults living in marginalized communities.\n\nStudy hypotheses include:\n\n* Participants in the Health Impact 360 intervention arm will have better CVH (i.e., a higher overall LE8 score) at the 16-week endpoint compared to the control.\n* Participants in the Health Impact 360 intervention arm will report better mental health (i.e., a lower perceived stress score) at the 16-week endpoint compared to the control.\n* Participants in the Health Impact 360 intervention arm will report better social support and well-being (i.e., higher emotional support and instrumental support scores and reduced social isolation) at the 16-week endpoint compared to control.\n* Participants with greater intervention engagement (e.g., better session attendance) will experience greater intervention impacts across all primary and secondary outcomes relative to the minimally engaged peers.\n\nResearchers will compare outcomes among intervention participants to outcomes among delayed intervention control participants who will be invited to participate in Health Impact 360 once all endpoint measures are collected.\n\nParticipants will:\n\n* Engage in group-based programming twice per week for 8 weeks\n* Engage in group-based programming once per week for 8 weeks\n* Participate in survey-based and biometric data collection at two timepoints: baseline and 16-week endpoint\n* Self-monitor their physical activity via a study-provided pedometer",null,[18,19],"Health Promotion","Cardiovascular Health",[21,22,23,24,25,26,27,28,29],"Health Program","Health outcomes","Social health","Walking","Health Education and support","Mental health","social support","Health disparities","self management","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},328,"ESTIMATED",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Health Impact 360","Participants will be assigned to a team and teams will meet 1-2 times per week for sessions at a local community organization. Sessions will be up to 2 hours long and will include two parts: (1) 30-60 minutes of activities related to physical, mental, social, financial, and community health, and (2) 60-75 minutes of group physical activity (walking), including stretches to warm up and cool down.",[40],{"type":13,"name":44,"description":45,"armGroupLabels":46},"Usual care - Wait list control","Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.",[44],[48],{"measure":49,"description":50,"timeFrame":51},"Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)","LE8 CVH Score will be averaged for each participant at baseline and 16 weeks on the individual LE8 metrics (i.e., scores of 0-100 for eight items). An average score of 0 to 49 is defined as low CVH, 50 to 79 is moderate CVH, and 80 to 100 is high CVH.","Baseline, 16 weeks",[53,56,59,62],{"measure":54,"description":55,"timeFrame":51},"Change in mental health based on the perceived stress scale","The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \\& 4 = 0) to the four positively stated items (items 4, 5, 7, \\& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.",{"measure":57,"description":58,"timeFrame":51},"Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale","This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more emotional support.",{"measure":60,"description":61,"timeFrame":51},"Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale","This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more instrumental support.",{"measure":63,"description":64,"timeFrame":51},"Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale","This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating greater social isolation.","ALL","18 Years",true,{"inclusion":69,"exclusion":72,"raw_text":73},[70,71],"English or Spanish speaking","Able to participate in group-based programming",[],"Inclusion Criteria:\n\n* English or Spanish speaking\n* Able to participate in group-based programming\n\nExclusion Criteria:\n\n\\- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses",[75,76],"ADULT","OLDER_ADULT",[78,88,92,96,109,114,121],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Community Health and Social Service Centers (CHASS)","COMPLETED","Detroit","Michigan","48209","United States",{"lat":86,"lon":87},42.33143,-83.04575,{"facility":89,"status":80,"city":81,"state":82,"zip":90,"country":84,"geoPoint":91},"Eastside Community Network (ECN)","48215",{"lat":86,"lon":87},{"facility":93,"status":80,"city":81,"state":82,"zip":94,"country":84,"geoPoint":95},"Detroit Hispanic Development Corporation (DHDC)","48216",{"lat":86,"lon":87},{"facility":97,"status":7,"city":98,"state":82,"zip":99,"country":84,"contacts":100,"geoPoint":106},"Hasselbringe Senior Center","Flint","48504",[101],{"name":102,"role":103,"phone":104,"email":105},"Tarnesa Martin","CONTACT","313-583-7088","healthimpact360@umich.edu",{"lat":107,"lon":108},43.01253,-83.68746,{"facility":110,"status":7,"city":98,"state":82,"zip":99,"country":84,"contacts":111,"geoPoint":113},"Spirit of Victory",[112],{"name":102,"role":103,"phone":104,"email":105},{"lat":107,"lon":108},{"facility":115,"status":7,"city":98,"state":82,"zip":116,"country":84,"contacts":117,"geoPoint":120},"Flint Development Center","48505",[118],{"name":119,"role":103,"phone":104,"email":105},"Latressa Gordon",{"lat":107,"lon":108},{"facility":122,"status":7,"city":98,"state":82,"zip":116,"country":84,"contacts":123,"geoPoint":125},"RL Jones Community Center",[124],{"name":119,"role":103,"phone":104,"email":105},{"lat":107,"lon":108},[127],{"name":128,"role":103,"phone":129,"email":130},"Michelle Clayson","734-763-2003","mclayson@umich.edu",[132],{"name":133,"affiliation":12,"role":134},"Jennifer Garner, PhD, RD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":138,"biomarkers":140},[139],"Primary prevention of cardiovascular disease",[],{"nct_id":4,"found":67,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This interventional study plans to enroll 328 participants. Participants will be assigned to either the Health Impact 360 program or a waitlist control group.","completed","Health Impact 360 for Cardiovascular Disease Prevention","This study is testing a program called Health Impact 360 to see if it can improve heart health (cardiovascular health or CVH), including physical, mental, and social well-being, for adults in underserved communities. You would either join a team for weekly sessions focusing on different aspects of health, or be part of a waitlist control group. Researchers want to see if those in the Health Impact 360 program have better heart health and mental well-being after 16 weeks compared to the control group. The study is looking for about 328 participants who are 18 or older, speak English or Spanish, and can join group activities. Pregnant individuals cannot participate.","Participants' cardiovascular health and mental health will be measured at the start and after 16 weeks.",109,"If in the Health Impact 360 group, you would meet 1-2 times per week for sessions up to 2 hours long. If in the control group, you would complete data collection at the start and after 16 weeks.","Not stated in the trial record.",[40],"v2"]