What side effects are associated with this type of intervention?

The trial 'Telehealth Delivery of GLB-TBI' focuses on lifestyle and behavioral changes for individuals with TBI. Common treatments in this category include dietary modifications, physical activity, and psychoeducation. Known side effects of these interventions are generally minimal but can include temporary discomfort or fatigue from increased physical activity, dietary adjustments, and the psychological impact of behavior change. These interventions are typically well-tolerated and aim to improve overall health and well-being.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for drugs or treatments for Traumatic Brain Injury (TBI). However, the trial for telehealth delivery of GLB-TBI focuses on lifestyle and behavioral changes, which are non-pharmacologic interventions aimed at weight loss and health improvement. These types of interventions typically do not require FDA approval as they are not drug-based treatments. Instead, they involve structured programs like the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB), which has been adapted for people with TBI to reduce health inequities and improve accessibility through telehealth.

What other types of research exist?

Promising alternatives to telehealth delivery of GLB-TBI for TBI patients in 2024 include in-person rehabilitation programs, hybrid models combining in-person and remote sessions, and the use of advanced technologies such as virtual reality (VR) and artificial intelligence (AI) to enhance patient engagement and adherence.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, and 12 months for reporting.

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 more

Awards & 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).

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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.