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Group Lifestyle Balance Program for Traumatic Brain Injury
N/A
Waitlist Available
Led By Simon Driver, PhD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, and 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a GLB program can help people with TBI lose weight and improve other outcomes, measured at 3, 6, 12, and 18 months.
Who is the study for?
This trial is for adults aged 18-64 who are at least 6 months post-traumatic brain injury (TBI), have a BMI of 25 or higher, and can use a smartphone or tablet. They must not be in certain care facilities, pregnant, have an eating disorder, low cognitive function, or conditions that make physical activity unsafe.
What is being tested?
The study tests the Group Lifestyle Balance™ program's effectiveness on weight management and other health outcomes for TBI patients compared to an attention control group. Progress is measured at several intervals up to 18 months after joining.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but will vary based on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, 12, and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 12, and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in weight
Secondary study objectives
10 Meter Walk Test (10MWT)
6 Minute Walk Test (6MWT)
App Data
+25 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GLB Weight-Loss InterventionExperimental Treatment1 Intervention
The GLB program, adapted for individuals with TBI, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week).
Group II: Attention Control GroupActive Control1 Intervention
The attention control group will meet at the same frequency as the GLB-TBI group over a 12-month period. The attention control group will receive education composed of the content from the TBI Model Systems Knowledge Translation Center's factsheets. No education on weight-loss strategies will be provided.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,086 Previous Clinical Trials
1,058,605 Total Patients Enrolled
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,368 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
80 Previous Clinical Trials
10,090 Total Patients Enrolled
Simon Driver, PhDPrincipal InvestigatorBaylor Scott & White Institute for Rehabilitation
1 Previous Clinical Trials
88 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are overweight.You are between 18 and 64 years old.You have been previously diagnosed with an eating disorder.People who have participated in the study before.You are currently using medicine for type 2 diabetes.You have a moderate to severe traumatic brain injury.You must be at least 6 months past a traumatic brain injury.You have a medical condition that makes physical activity unsafe for you.You have trouble with your memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: GLB Weight-Loss Intervention
- Group 2: Attention Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.