Telehealth Weight-loss Program for Traumatic Brain Injury

(tGLB-TBI Trial)

Overseen by Simon Driver, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor Research Institute

Must not be taking: Diabetes medications

Disqualifiers: Type 2 diabetes, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications for Type 2 diabetes.

What data supports the effectiveness of the treatment Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI)?

Research shows that people with traumatic brain injury (TBI) who participated in an in-person version of this program lost an average of 17.8 pounds, which is about 7.9% of their body weight. This suggests that the program can help people with TBI lose weight and improve their health. ^{1 2 3 4 5}

Is the Telehealth Weight-loss Program for Traumatic Brain Injury safe for humans?

The Telehealth Weight-loss Program for Traumatic Brain Injury, also known as tGLB-TBI, has been adapted from a well-established lifestyle program and has been tested in people with traumatic brain injury. While the studies focus on its effectiveness, they do not report any specific safety concerns, suggesting it is generally safe for human use. ^{1 2 3 4 6}

How is the Telehealth Weight-loss Program for Traumatic Brain Injury different from other treatments for TBI?

The Telehealth Weight-loss Program for Traumatic Brain Injury (tGLB-TBI) is unique because it adapts a proven weight-loss program to meet the specific needs of people with TBI and delivers it via telehealth, making it accessible to those who may face barriers like living in rural areas or lacking transportation. This approach not only addresses weight management but also aims to reduce health disparities by providing a scalable solution for individuals with TBI. ^{1 2 3 5 7}

Research Team

Simon Driver, PhD

Principal Investigator

Baylor Research Institute

Eligibility Criteria

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.

Inclusion Criteria

Willing to use a tablet/computer/smartphone (either personal device or one provided by the research team)

I am between 18 and 80 years old.

It has been over 6 months since my traumatic brain injury.

Exclusion Criteria

I am not fluent in English.

I have been diagnosed with an eating disorder before.

Contraindications to physical activity (e.g., uncontrolled hypertension, unstable angina, severe joint disease, uncontrolled vertigo/dizziness)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Program

Participants engage in 12 weekly sessions focusing on weight-loss through physical activity and healthy eating, delivered via telehealth.

12 weeks

12 visits (virtual)

Transition Phase

Participants attend 2 bi-weekly and 2 monthly sessions to transition from the core program, focusing on maintaining weight-loss.

8 weeks

4 visits (virtual)

Support Phase

Participants attend 6 monthly sessions to support long-term weight maintenance and health improvements.

6 months

6 visits (virtual)

Follow-up

Participants are monitored for changes in weight, metabolic health, and quality of life after the intervention.

12 months

Treatment Details

Interventions

• Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Telehealth GLB-TBI (tGLB-TBI) Experimental Treatment 1 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 Control 1 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).

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

North Texas Traumatic Brain Injury Model System (NTX-TBIMS)

Collaborator

Trials

1

Recruited

90+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Dr. Kristi Hill

National Institute on Disability, Independent Living, and Rehabilitation Research

Acting Director since 2012

PhD in Neuroscience from the Medical College of Virginia

Dr. Phillip Beatty

National Institute on Disability, Independent Living, and Rehabilitation Research

Director of the Office of Research Sciences since 2019

PhD in Rehabilitation Sciences

Findings from Research

The study is a randomized controlled trial (RCT) designed to evaluate the modified Group Lifestyle Balance™ program (GLB-TBI) for weight management in overweight and obese individuals with traumatic brain injury (TBI), enrolling 66 participants over two years.

The goal of the RCT is to establish the efficacy of GLB-TBI as a weight-loss intervention tailored for the unique needs of the TBI population, potentially leading to recognition by health authorities and reimbursement for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI). Driver, S., Juengst, S., McShan, EE., et al.[2023]

A participatory action research approach was used to adapt the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) for overweight/obese individuals with traumatic brain injury (TBI), involving a committee of 10 stakeholders including clinicians, patients, and caregivers.

The modifications included TBI-specific recommendations for physical activity and nutrition, as well as strategies for caregiver involvement, which could enhance the program's effectiveness and applicability in community settings if proven successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying an evidence-based lifestyle programme for individuals with traumatic brain injury. Driver, S., Reynolds, M., Kramer, K.[2018]

A randomized controlled trial with 57 adults who had traumatic brain injury (TBI) showed that participants lost an average of 17.8 pounds (7.9% of their body weight) after completing the modified Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI), compared to no weight loss in the control group.

To make this weight-loss intervention more accessible, a new randomized controlled trial will test a telehealth version of the program (tGLB-TBI) with 88 participants over 3 years, aiming to help individuals with TBI who face barriers to accessing traditional programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI). Driver, S., McShan, EE., Bennett, M., et al.[2023]

The adapted Group Lifestyle Balance (GLB) intervention was successfully implemented in a diabetes education program, showing feasibility and effectiveness for weight management among 111 overweight/obese adults, regardless of their diabetes status.

Participants achieved significant weight loss and increased their physical activity, with many reporting exercising at least 150 minutes per week after completing the 12-week program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the Group Lifestyle Balance™ Program for Weight Management Within a Large Health Care System Diabetes Education Program. Greenwood, DA., Kramer, MK., Hankins, AI., et al.[2021]

Telehealth programs designed to support family members of individuals with traumatic brain injury have shown positive outcomes in 15 studies, indicating their effectiveness and feasibility as a support method.

Despite the promising results, most studies lacked blinded assessors, highlighting the need for further research to compare telehealth with traditional face-to-face interventions and to enhance clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting family members of people with traumatic brain injury using telehealth: a systematic review. Rietdijk, R., Togher, L., Power, E.[2019]

The Group Lifestyle Balance program (GLB), adapted from the Diabetes Prevention Program (DPP), was evaluated in a pilot project using a DVD format with remote support.

Results indicate that the GLB-DVD with remote support could be an effective alternative method for delivering lifestyle intervention programs, potentially improving accessibility for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

The GLB-TBI weight-loss intervention led to a significant average weight loss of 17.8 lbs (7.9%) over 12 months in individuals with moderate to severe traumatic brain injury, compared to no weight loss in the attention control group.

Participants in the GLB-TBI group also showed improvements in important health markers such as diastolic blood pressure, triglycerides, and HDL cholesterol, indicating that the program not only aids in weight loss but also enhances metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial. Driver, S., McShan, E., Swank, C., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI). [2023]

2. England pubmed.ncbi.nlm.nih.gov

Modifying an evidence-based lifestyle programme for individuals with traumatic brain injury. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI). [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Adapting the Group Lifestyle Balance™ Program for Weight Management Within a Large Health Care System Diabetes Education Program. [2021]

5. Sweden pubmed.ncbi.nlm.nih.gov

Supporting family members of people with traumatic brain injury using telehealth: a systematic review. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

A novel approach to diabetes prevention: evaluation of the Group Lifestyle Balance program delivered via DVD. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Diabetes Prevention Program Group Lifestyle Balance Program Modified for Individuals with TBI (GLB-TBI): Results from a 12-month Randomized Controlled Trial. [2023]