An observational study in Traumatic Brain Injury, Brain Injuries, Traumatic and Brain Injury, Chronic, sponsored by Baylor Research Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Baylor Research Institute · Observational
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 70 is below the median of 118 across 562 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults (18-80 years of age) who are at least 6 months post moderate to severe traumatic brain injury (TBI) and willing to participate in a 12-month, 22-session healthy lifestyle intervention.
18-80 years of age
-≥6 months post-TBI
Exclusion Criteria:
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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. Cohorts consist of 8-10 people.
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
Body Weight
Body weight will be measured at each session using an accessible scale.
Time frame: Baseline and 12 months
Blood Pressure
Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics.
Time frame: Baseline and 12 months
Hemoglobin A1c
Blood sample will be obtained either in person or via Quest Diagnostics.
Time frame: Baseline and 12 months
Fasting Blood Glucose
Blood sample will be obtained either in person or via Quest Diagnostics.
Time frame: Baseline and 12 months
Lipid Panel
Blood sample will be obtained either in person or via Quest Diagnostics.
Time frame: Baseline and 12 months
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.
Time frame: Baseline and 12 months
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.
Time frame: 12 months
Plan to share: Undecided — Please contact the PI
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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