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| ID | Type | Description | Link |
|---|---|---|---|
| 90IFRE0110 | Other Grant/Funding Number | National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | 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. |
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| Cohort 2 | 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. |
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| Cohort 3 | 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. |
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| Cohort 4 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Lifestyle Balance for People with TBI (GLB-TBI) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight will be measured at each session using an accessible scale. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics. | Baseline and 12 months |
| Hemoglobin A1c | Blood sample will be obtained either in person or via Quest Diagnostics. |
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Inclusion Criteria:
18-80 years of age
-≥6 months post-TBI
Moderate to severe TBI at time of injury
BMI ≥25 kg/m2
Able to communicate in English
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandria Suhalka, MPH | Contact | 214-865-2496 | Alexandria.Suhalka@BSWHealth.org | |
| Shahad Alrawi, MS | Contact | 214-820-9324 | Shahad.Arawi@BSWHealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Evan McShan, PhD | Baylor Scott & White Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Research Institute | Dallas | Texas | 75204 | United States |
Please contact the PI
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| Cohort 5 | 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. |
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| Cohort 6 | 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. |
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| Cohort 7 | 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. |
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| Cohort 8 | 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. |
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| Cohort 9 | 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. |
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| Baseline and 12 months |
| Fasting Blood Glucose | Blood sample will be obtained either in person or via Quest Diagnostics. | Baseline and 12 months |
| Lipid Panel | Blood sample will be obtained either in person or via Quest Diagnostics. | 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. | 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. | 12 months |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020208 | Brain Injury, Chronic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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