[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06989281":3,"trial-entities:NCT06989281":96,"trial-summary:NCT06989281":106},{"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":20,"study_type":25,"primary_purpose":14,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":47,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":77,"locations":80,"central_contacts":89,"overall_officials":90,"references":94,"see_also_links":95},"NCT06989281","IRB-300013918","Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB","Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care","ENROLLING_BY_INVITATION","2026-12-31","2026-05","2026-05-22","2025-05-03","University of Alabama at Birmingham","OTHER",false,"This is a randomized quality improvement project (i.e., not a research study) that will test the implementation and effectiveness of a lifestyle medicine clinic at the University of Alabama at Birmingham.","This is a randomized quality improvement project that has received a non-human subjects research determination from the IRB at the University of Alabama at Birmingham. This study will use a randomized encouragement trial design to test whether a lifestyle medicine clinic at UAB (FLOW: Fitness, Lifestyle, and Optimum Wellness) is implementable and effective for improving cardiometabolic health (e.g., body weight, body composition, blood pressure, blood glucose, and blood lipids). Only patients of the UAB Family and Community Clinic are included in this project (i.e., no outside recruitment\u002Fenrollment).",[19],"Obesity and Obesity-related Medical Conditions",[21,22,23,24],"Quality Improvement Project","Implementation","Clinical Effectiveness","Encouragement Design","INTERVENTIONAL",[27],"NA",{"count":29,"type":30},1000,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","FLOW Lifestyle Medicine Clinic","The FLOW Lifestyle Medicine Clinic is a 12-month multidisciplinary program for improving obesity and obesity-related chronic conditions. FLOW is an evidence-based program that aligns with USPSTF recommendations for intensive behavioral counseling for obesity and cardiovascular disease risk reduction. There are at least 12 clinician\u002Fpatient encounters in the FLOW clinic over 12 months including 6 with a registered dietitian and 6 with a FLOW physician. Behavioral Health assessments and visits are also offered as part of FLOW but are optional.",[37,38],"Encouraged to Enroll in FLOW","Not Encouraged to Enroll in FLOW",[40,44],{"measure":41,"description":42,"timeFrame":43},"Rate of Referral","Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.","Baseline",{"measure":45,"description":46,"timeFrame":43},"Rate of Enrollment","Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.",[48,52,56,59],{"measure":49,"description":50,"timeFrame":51},"ITT Estimand, Change in Body Weight","A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged.","Baseline and 12 months",{"measure":53,"description":54,"timeFrame":55},"ITT Estimand, Change in Composite Cardiometabolic Health","A comparison of changes in cardiometabolic health occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged. The composite score is derived from values for body weight, percentage body fat, blood pressure, clinical labs, fitness tests, and questionnaires.","Baseline to Month 12",{"measure":57,"description":58,"timeFrame":51},"Complier Average Causal Effect, Change in Body Weight","A comparison body weight changes occurring over 12 months between patients who enrolled vs. did not enroll in FLOW regardless of whether they were assigned to Encouraged or Not Encouraged.",{"measure":60,"description":61,"timeFrame":55},"Complier Average Causal Effect, Change in Composite Cardiometabolic Health","A comparison changes in cardiometabolic health occurring over 12 months between patients who enrolled vs. did not enroll in FLOW regardless of whether they were assigned to Encouraged or Not Encouraged. The composite score is derived from values for body weight, percentage body fat, blood pressure, clinical labs, fitness tests, and questionnaires.","ALL","18 Years","89 Years",{"inclusion":66,"exclusion":74,"raw_text":76},[67,68,69,70,71,72,73],"Current patient of the UAB Family \\& Community Medicine Clinic or UAB Rheumatology Clinic","BMI: greater than or equal to 25 kg\u002Fm2","Previous diagnosis of at least one of the following conditions:","prediabetes or type 2 diabetes","prehypertension or hypertension","dyslipidemia","psoriatic arthritis",[75],"Not a current patient of the UAB Family \\& Community Medicine Clinic or UAB Rheumatology Clinic","Inclusion Criteria:\n\n* Current patient of the UAB Family \\& Community Medicine Clinic or UAB Rheumatology Clinic\n* BMI: greater than or equal to 25 kg\u002Fm2\n* Previous diagnosis of at least one of the following conditions:\n* prediabetes or type 2 diabetes\n* prehypertension or hypertension\n* dyslipidemia\n* psoriatic arthritis\n\nExclusion Criteria:\n\n* Not a current patient of the UAB Family \\& Community Medicine Clinic or UAB Rheumatology Clinic",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":13,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Birmingham","Alabama","35294","United States",{"lat":87,"lon":88},33.52066,-86.80249,[],[91],{"name":92,"affiliation":13,"role":93},"Drew Sayer, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":105},[98,99,100,101,102,103,104],"Dyslipidemia","Hypertension","Obesity","Prediabetes","Prehypertension","Psoriatic Arthritis","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":107,"prompt_version":107},null]