Brain Injuries, Traumatic, Brain Injury, Chronic, Traumatic Brain Injury
Conditions
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALGroup 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
Sponsors
Baylor Research Institute
National Institute on Disability, Independent Living, an Rehabilitation Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Baseline and 12 months | Body weight will be measured at each session using an accessible scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline and 12 months | Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics. |
| Hemoglobin A1c | Baseline and 12 months | Blood sample will be obtained either in person or via Quest Diagnostics. |
| Fasting Blood Glucose | Baseline and 12 months | Blood sample will be obtained either in person or via Quest Diagnostics. |
| Lipid Panel | Baseline and 12 months | Blood sample will be obtained either in person or via Quest Diagnostics. |
| Self-Efficacy | Baseline and 12 months | 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. |
| Exit Survey | 12 months | 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. |
Countries
United States
Contacts
CONTACTAlexandria Suhalka, MPH
CONTACTShahad Alrawi, MS
PRINCIPAL_INVESTIGATOREvan McShan, PhD
Baylor Scott & White Research Institute
Outcome results
None listed