[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220213":3,"trial-entities:NCT07220213":132,"trial-summary:NCT07220213":139},{"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":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":86,"minimum_age":87,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":88,"std_ages":104,"locations":107,"central_contacts":124,"overall_officials":129,"references":130,"see_also_links":131},"NCT07220213","IRB-300015137","FELLAShip to Better Health","RECRUITING","2027-01-01","2026-01","2026-01-22","2026-01-01","University of Alabama at Birmingham","OTHER",false,"The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are:\n\n* Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)?\n* What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors.\n\nParticipants will:\n\n* Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches.\n* Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care.\n* Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes.\n* Use a smartwatch, blood pressure cuff, and other tools to track progress in real time.\n* Participate in exit focus groups or interviews to share feedback about the intervention.\n* A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability.\n\nThis study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.",null,[18,19,20,21,22,23],"High Blood Glucose","High Cholesterol","High Cholesterol\u002FHyperlipidemia","Blood Sugar; High","Obesity & Overweight","Diabetes Type 2",[],"INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},90,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","FELLAship","TheFELLAship intervention, grounded in Social Cognitive Theory (SCT) and guided by the Socioecological Model (SEM), focuses on enhancing participants' skills, knowledge and beliefs, and self-efficacy to promote cardiovascular health (CVH). The program provides health education aligned with the Diabetes Prevention Program (DPP) and American Heart Association's Check. Change. Control. (AHA CCC) curriculum to support behavior change in diet, physical activity, tobacco use, sleep, and clinical care engagement. Team-based coaching and physical activity sessions strengthen behavioral confidence and skill application.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Change From Baseline in Life's Essential 8 Overall Score","Change from baseline in the Life's Essential 8 overall cardiovascular health score (range 0-100, higher scores indicate better cardiovascular health), assessed at 12 and 24 weeks.","24 Weeks",[44,47,50,53,57,60,63,66,69,72,75,78,82],{"measure":45,"description":46,"timeFrame":42},"Change From Baseline in Life's Essential 8 Blood Pressure Score","Change from baseline in the Life's Essential 8 blood pressure subscore (range 0-100, higher scores indicate better cardiovascular health), derived from systolic and diastolic blood pressure measured using an automated sphygmomanometer.",{"measure":48,"description":49,"timeFrame":42},"Change From Baseline in Life's Essential 8 Body Mass Index Score","Change from baseline in the Life's Essential 8 body mass index subscore (range 0-100, higher scores indicate better cardiovascular health), calculated using measured height (inches) and weight (pounds) to derive BMI.",{"measure":51,"description":52,"timeFrame":42},"Change in Life's Essential 8 Diet (subjective)","Change from baseline in the Life's Essential 8 diet subscore (range 0-100, higher scores indicate better cardiovascular health), measured using the 16-item Mediterranean Eating Pattern for Americans questionnaire.",{"measure":54,"description":55,"timeFrame":56},"Change From Baseline in Life's Essential 8 Blood Lipids Score","Change from baseline in the Life's Essential 8 blood lipids subscore (range 0-100, higher scores indicate better cardiovascular health), derived from non-HDL cholesterol measured from a blood sample.","24",{"measure":58,"description":59,"timeFrame":42},"Change From Baseline in Life's Essential 8 Blood Glucose Score","Change from baseline in the Life's Essential 8 blood glucose subscore (range 0-100, higher scores indicate better cardiovascular health), derived from hemoglobin A1c measured from a blood sample.",{"measure":61,"description":62,"timeFrame":42},"Change From Baseline in Perceived Stress Score","Change from baseline in perceived stress, measured using the Perceived Stress Scale (PSS) score.",{"measure":64,"description":65,"timeFrame":42},"Change in Life's Essential 8 Physical Activity (Self Reported)","Change from baseline in the Life's Essential 8 physical activity subscore (range 0-100, higher scores indicate better cardiovascular health), derived from self-reported minutes of moderate or vigorous physical activity per week.",{"measure":67,"description":68,"timeFrame":42},"Change in Life's Essential 8 Physical Activity (Accelerometry)","Change from baseline in the Life's Essential 8 physical activity subscore (range 0-100, higher scores indicate better cardiovascular health), derived from 7 days of accelerometry data collected using an ActiGraph device.",{"measure":70,"description":71,"timeFrame":42},"Change From Baseline in Life's Essential 8 Nicotine Exposure Score","Change from baseline in the Life's Essential 8 nicotine exposure subscore (range 0-100, higher scores indicate better cardiovascular health), based on self-reported use of cigarettes or inhaled nicotine delivery systems.",{"measure":73,"description":74,"timeFrame":42},"Change From Baseline in Life's Essential 8 Sleep Health Score","Change from baseline in the Life's Essential 8 sleep health subscore (range 0-100, higher scores indicate better cardiovascular health), measured using self-reported average hours of sleep per night.",{"measure":76,"description":77,"timeFrame":42},"Change From Baseline in Patient Activation Measure (PAM) Score","Change from baseline in patient activation, measured using the Patient Activation Measure (PAM) score.",{"measure":79,"description":80,"timeFrame":81},"Change From Baseline in Health-Related Social Needs Score","Change from baseline in health-related social needs, measured using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening Tool.","24 weeks",{"measure":83,"description":84,"timeFrame":85},"RE-AIM Adoption, Implementation, and Maintenance Indicators","Adoption, implementation, and maintenance indicators of the FELLAship intervention, assessed using structured interviews, meeting documentation, and organizational records in alignment with the RE-AIM framework.","156 Weeks","MALE","18 Years",{"inclusion":89,"exclusion":96,"raw_text":103},[90,91,92,93,94,95],"Self-identified Black men","Age 18 or older","LE8 (Life's Essential 8) score (threshold not specified, but implies \"less than ideal\" CVH)","English speaking","Resides in the Metropolitan Birmingham, Alabama area","No physical activity restrictions imposed by a healthcare provider",[97,98,99,100,101,102],"Not identifying as Black and male","Under age 18","Non-English speakers","Not living in the Birmingham, Alabama metro area","Having a healthcare provider-imposed restriction on physical activity","Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)","Inclusion Criteria:\n\n* Self-identified Black men\n* Age 18 or older\n* LE8 (Life's Essential 8) score (threshold not specified, but implies \"less than ideal\" CVH)\n* English speaking\n* Resides in the Metropolitan Birmingham, Alabama area\n* No physical activity restrictions imposed by a healthcare provider\n\nExclusion Criteria:\n\n* Not identifying as Black and male\n* Under age 18\n* Non-English speakers\n* Not living in the Birmingham, Alabama metro area\n* Having a healthcare provider-imposed restriction on physical activity\n* Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":109,"status":7,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":121},"The Worship Center Cristian Church","Birmingham","Alabama","35210","United States",[115],{"name":116,"role":117,"phone":118,"phoneExt":119,"email":120},"Jeff Givhan","CONTACT","205-451-1750","4942","jgivhan@theworshipcentercc.org",{"lat":122,"lon":123},33.52066,-86.80249,[125],{"name":126,"role":117,"phone":127,"email":128},"LeAndrea D Anderson","2059960089","leandreaanderson@uabmc.edu",[],[],[],{"nct_id":4,"conditions":133,"biomarkers":138},[134,135,136,137],"Hyperglycemia","Hyperlipidemia","Obesity","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":140,"summary":141,"prompt_version":151},true,{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This study is an interventional study, meaning participants will receive the FELLAship program. It plans to enroll 90 participants.","completed","FELLAship to Better Health for Black Men","This study is testing a program called FELLAship, which is a church-based program designed to improve heart health in Black men. It aims to help men who are at risk for conditions like high blood sugar, high cholesterol, and obesity. The program focuses on improving your skills, knowledge, and confidence to make healthy choices. Researchers want to see if participating in FELLAship improves heart health measures (like blood pressure and blood sugar) and healthy behaviors. They also want to understand what helps this program work well in a church setting. You may be able to join if you are a Black man, aged 18 or older, live in the Birmingham, Alabama area, speak English, and have some risk factors for heart disease.","Your heart health will be assessed at 24 weeks after starting the program.",122,"The study will measure changes in your overall heart health score after 24 weeks. Specific details about visits or procedures are not provided.","Not stated in the trial record.",[35],"v2"]