Telehealth Weight-loss Program for Traumatic Brain Injury

(tGLB-TBI Trial)

Overseen By Stephanie Calhoun

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Diabetes medications

Disqualifiers: Type 2 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth weight-loss program designed specifically for individuals who have experienced a traumatic brain injury (TBI). The goal is to make weight loss more accessible and help participants lose 5-7% of their body weight by focusing on physical activity and healthy eating. The trial compares this program, known as the Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI), to a brain health-focused group to determine which is more effective. Eligible participants have had a moderate to severe TBI over six months ago, struggle with weight (BMI of 25 or higher), and are comfortable using digital devices like a tablet or smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve weight-loss strategies for individuals 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 prior data suggests that this telehealth program is safe for people with TBI?

Research shows that the Group Lifestyle Balance program, now adapted for individuals with traumatic brain injuries (TBI), is generally safe. This program promotes physical activity and healthy eating. Previous studies have found that similar lifestyle programs are well-received by participants, with no serious side effects reported.

The program recommends moderate exercise and a balanced diet. Delivered through telehealth, it offers convenience by allowing participation without travel. Although this specific TBI program is new, its core components have been safely used with other groups before.

Currently, no evidence indicates major safety issues with this telehealth version of the program. However, participants should consult their healthcare provider about any personal health concerns before starting a new program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Group Lifestyle Balance for Traumatic Brain Injury (tGLB-TBI) program because it offers a fresh approach to weight loss for individuals with TBI. Unlike standard treatments that may focus solely on medication or dietary changes, this program combines telehealth delivery with both physical activity and healthy eating guidelines. The telehealth format ensures accessibility and convenience, allowing participants to engage in the program from home. Additionally, the group setting fosters a supportive community, which can enhance motivation and adherence to lifestyle changes. By targeting both physical activity and diet in a structured, year-long program, researchers hope to achieve sustainable weight loss and improved health outcomes for people with TBI.

What evidence suggests that the telehealth-delivered Group Lifestyle Balance for people with TBI could be an effective weight-loss treatment for traumatic brain injury?

Research has shown that the Group Lifestyle Balance program, adapted for individuals with Traumatic Brain Injury (GLB-TBI), aids in weight loss. One study found that adults with TBI who completed the in-person program lost an average of 17.8 pounds, or about 7.9% of their body weight. This weight loss also reduced metabolic health risks, enhancing overall health. In this trial, participants in the Telehealth GLB-TBI arm will follow a telehealth version of the program, designed to provide the same benefits by improving accessibility for people with TBI. Meanwhile, participants in the Brain Health Group arm will concentrate on brain health education, self-management, and problem-solving without receiving weight-loss education. ^{2 3 6 7 8}

Who Is on the Research Team?

Simon Driver, PhD

Principal Investigator

Baylor Research Institute

Are You a Good Fit for This Trial?

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)

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37520329/

A randomized controlled trial protocol for people with ... Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001370

A randomized controlled trial protocol for people with ... Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05699772

Expanding Delivery of an Evidence-based Weight-loss ... The GLB-TBI is modified for people with Traumatic Brain Injury and addresses their unique weight loss and healthy lifestyle needs. Participant Group/Arm, Active ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35775789/

Results from a 12-month Randomized Controlled Trial Findings suggest for adults with TBI who are overweight or obese, participation in the GLB-TBI can significantly reduce weight and metabolic risk factors.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05699772/expanding-delivery-of-an-evidence-based-weight-loss-intervention-to-enhance-access-and-reach-underserved-groups-after-tbi

Expanding Delivery of an Evidence-based Weight-loss ... Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382627/

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

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865418301765

A randomized controlled trial protocol for people with ... The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based physical activity and healthy eating program that has been used extensively with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03594734

Study Details | NCT03594734 | Group Lifestyle Balance™ ... The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary ( ...