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Behavioral Intervention
Telehealth Weight-loss Program for Traumatic Brain Injury (tGLB-TBI Trial)
N/A
Recruiting
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test an online weight-loss program specifically designed for people with traumatic brain injuries. The program helps participants lose weight by encouraging more exercise and healthier eating habits. The goal is to make this effective program accessible to a wider range of people with TBI.
Who is the study for?
This trial is for adults aged 18-80 with moderate to severe TBI, a BMI of 25 or higher, and at least 6 months post-injury. Participants must be able to exercise and willing to use digital devices for telehealth. It excludes those with conditions limiting physical activity, non-English speakers, low cognitive function, institutional residents, diabetes patients, pregnant individuals or those with eating disorders.
What is being tested?
The study tests the effectiveness of a weight-loss program adapted for people with TBI (tGLB-TBI) delivered via telehealth against a Brain Health Group (BHG). The aim is to make this intervention widely accessible and improve health outcomes in the underserved population after TBI.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical responses to diet change or increased physical activity such as muscle soreness or fatigue. Specific side effects will depend on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, and 12 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
Change in 8-Year Diabetes Risk
Change in Arm Circumference
Change in Blood Pressure
+11 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: Telehealth GLB-TBI (tGLB-TBI)Experimental Treatment1 Intervention
The goal of the tGLB-TBI program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach:
1. Physical activity: This is based upon recommendations by the American Heart Association and the American College of Sports Medicine (ACSM) to achieve 150 minutes of moderate intensity activity each week. Walking is the primary activity recommended.
2. Healthy eating: Based on United States Department of Agriculture guidelines, the GLB emphasizes healthy eating patterns and tracking dietary intake.
The tGLB-TBI was modified from the DPP-GLB and 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. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).
Group II: Brain Health Group (BHG)Active Control1 Intervention
The Brain Health Group (BHG) meets at the same frequency as the GLB-TBI (i.e., 22 group-based sessions, 12 weekly, 4 bi-monthly, and 6 monthly).The focus of the BHG is on brain health education, self-management, and problem-solving and the BHG did not receive any education on weight-loss strategies. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Traumatic Brain Injury (TBI) include behavioral and lifestyle interventions, which focus on weight loss, physical activity, and dietary changes. These treatments work by promoting neuroplasticity, reducing inflammation, and improving overall brain health.
For TBI patients, these mechanisms are crucial as they can help mitigate cognitive deficits, enhance recovery, and improve quality of life. The telehealth delivery of these interventions, such as the GLB-TBI program, increases accessibility and allows for continuous support, which is essential for sustained behavioral changes and long-term health benefits.
Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Pharmacological and non-pharmacological interventions of depression after traumatic brain injury: A systematic review.
Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Pharmacological and non-pharmacological interventions of depression after traumatic brain injury: A systematic review.
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,337 Total Patients Enrolled
North Texas Traumatic Brain Injury Model System (NTX-TBIMS)UNKNOWN
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
80 Previous Clinical Trials
10,059 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.I have been diagnosed with an eating disorder before.I am currently living in a hospital, rehab center, or skilled nursing facility.I am between 18 and 80 years old.I have been diagnosed with low cognitive function.I have been diagnosed with Type 2 diabetes or am taking medication for it.It has been over 6 months since my traumatic brain injury.You can take part in physical activities.I had a moderate to severe traumatic brain injury.You are overweight.
Research Study Groups:
This trial has the following groups:- Group 1: Telehealth GLB-TBI (tGLB-TBI)
- Group 2: Brain Health Group (BHG)
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.
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