Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury
GLB Scale-Up
2 other identifiers
observational
70
1 country
1
Brief Summary
We 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedStudy Start
First participant enrolled
August 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
Study Completion
Last participant's last visit for all outcomes
August 30, 2028
June 15, 2026
June 1, 2026
2 years
June 10, 2026
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Body Weight
Body weight will be measured at each session using an accessible scale.
Baseline and 12 months
Secondary Outcomes (6)
Blood Pressure
Baseline and 12 months
Hemoglobin A1c
Baseline and 12 months
Fasting Blood Glucose
Baseline and 12 months
Lipid Panel
Baseline and 12 months
Self-Efficacy
Baseline and 12 months
- +1 more secondary outcomes
Study Arms (9)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- years of age
- ≥6 months post-TBI
- Moderate to severe TBI at time of injury
- BMI ≥25 kg/m2
- Able to communicate in English
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan McShan, PhD
Baylor Scott & White Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 15, 2026
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
August 30, 2028
Last Updated
June 15, 2026
Record last verified: 2026-06