[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07648901":3,"trial-entities:NCT07648901":113,"trial-summary:NCT07648901":117},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":48,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":14,"eligibility_criteria":69,"std_ages":84,"locations":87,"central_contacts":97,"overall_officials":107,"references":111,"see_also_links":112},"NCT07648901","026-349","Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury","NOT_YET_RECRUITING","2028-08-30","2026-06","2026-06-16","2026-08-15","Baylor Research Institute","OTHER",false,"The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site","Despite strong efficacy data, CDC recognition of our modified curricula, and online training modules, efforts to ensure the systematic adoption of our GLB-TBI evidence based intervention (EBI) in real-world settings (i.e., CDC-recognized sites) remain limited, yet are critically needed. The proposed scale-up evaluation trial is an important and logical next step in this systematic line of research to increase the impact and scope of our GLB-TBI EBI. The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI EBI in a real world setting at a CDC-recognized site. Results will provide a scalable EBI that can be implemented at CDC-recognized sites nationally) to improve obesity and cardiometabolic health of people with TBI.",[18,19,20],"Traumatic Brain Injury","Brain Injuries, Traumatic","Brain Injury, Chronic",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},70,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Group Lifestyle Balance for People with TBI (GLB-TBI)","The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury",[34,35,36,37,38,39,40,41,42],"Cohort 1","Cohort 2","Cohort 3","Cohort 4","Cohort 5","Cohort 6","Cohort 7","Cohort 8","Cohort 9",[44],{"measure":45,"description":46,"timeFrame":47},"Body Weight","Body weight will be measured at each session using an accessible scale.","Baseline and 12 months",[49,52,55,57,59,62],{"measure":50,"description":51,"timeFrame":47},"Blood Pressure","Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics.",{"measure":53,"description":54,"timeFrame":47},"Hemoglobin A1c","Blood sample will be obtained either in person or via Quest Diagnostics.",{"measure":56,"description":54,"timeFrame":47},"Fasting Blood Glucose",{"measure":58,"description":54,"timeFrame":47},"Lipid Panel",{"measure":60,"description":61,"timeFrame":47},"Self-Efficacy","Self reported measure using the Self-Rated Abilities for Health Practice scale. Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices Score plus 4 subscale scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.",{"measure":63,"description":64,"timeFrame":65},"Exit Survey","Participants will be asked to complete Exit Survey at the 12-month assessment. This survey will ask about participant experience in, and satisfaction with, the GLB-TBI program and suggestions for improvement.","12 months","ALL","18 Years","80 Years",{"inclusion":70,"exclusion":76,"raw_text":83},[71,72,73,74,75],"18-80 years of age","≥6 months post-TBI","Moderate to severe TBI at time of injury","BMI ≥25 kg\u002Fm2","Able to communicate in English",[77,78,79,80,81,82],"Contraindications to physical activity","Low cognitive function","Residing in hospital, acute rehab, SNF","Self-Reported Pregnancy","Pre-existing diagnosis of an eating disorder","Former DPP-GLB Participants (less than 6months since participation ended)","Inclusion Criteria:\n\n* 18-80 years of age\n\n  -≥6 months post-TBI\n* Moderate to severe TBI at time of injury\n* BMI ≥25 kg\u002Fm2\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Contraindications to physical activity\n* Low cognitive function\n* Residing in hospital, acute rehab, SNF\n* Self-Reported Pregnancy\n* Pre-existing diagnosis of an eating disorder\n* Former DPP-GLB Participants (less than 6months since participation ended)",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"Baylor Scott & White Research Institute","Dallas","Texas","75204","United States",{"lat":95,"lon":96},32.78306,-96.80667,[98,103],{"name":99,"role":100,"phone":101,"email":102},"Alexandria Suhalka, MPH","CONTACT","214-865-2496","Alexandria.Suhalka@BSWHealth.org",{"name":104,"role":100,"phone":105,"email":106},"Shahad Alrawi, MS","214-820-9324","Shahad.Arawi@BSWHealth.org",[108],{"name":109,"affiliation":89,"role":110},"Evan McShan, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":116},[20,115],"Traumatic Encephalopathy",[],{"nct_id":4,"found":14,"summary":23,"prompt_version":23}]