Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group Lifestyle Balance for People with TBI (GLB-TBI).
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Brain Injuries, Traumatic, Brain Injury, Chronic. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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
Primary outcome measures
- Body Weight [Time frame: Baseline and 12 months]
Secondary outcome measures (6)
- Blood Pressure [Time frame: Baseline and 12 months]
- Hemoglobin A1c [Time frame: Baseline and 12 months]
- Fasting Blood Glucose [Time frame: Baseline and 12 months]
- Lipid Panel [Time frame: Baseline and 12 months]
- Self-Efficacy [Time frame: Baseline and 12 months]
- Exit Survey [Time frame: 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Baylor Scott & White Research Institute — Dallas
Identifiers
NCT: NCT07648901 · 026-349 · 90IFRE0110