Group Lifestyle Balance Program for Traumatic Brain Injury

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Type 2 diabetes medication

Disqualifiers: Pregnancy, Eating disorder, others

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

Compensation: Varies

Number of Visits: 22

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a Group Lifestyle Balance™ program for individuals who have experienced a traumatic brain injury (TBI) and wish to lose weight. Participants will join group sessions focused on weight loss through calorie reduction and increased exercise, while the control group will receive education on TBI-related topics without weight-loss strategies. The trial seeks participants who have had moderate to severe TBI for at least six months, have a BMI of 25 or higher, and can use a smartphone or tablet. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance lifestyle interventions for TBI patients.

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 currently taking medication for type 2 diabetes.

What prior data suggests that the Group Lifestyle Balance™ program is safe for individuals with traumatic brain injury?

Research has shown that the Group Lifestyle Balance (GLB) program is safe for people with traumatic brain injury (TBI). In one study, participants in the GLB program lost an average of 17.8 pounds over a year, demonstrating its effectiveness for weight loss. The study reported no serious side effects. Participants engaged in regular exercise and reduced calorie intake, activities generally safe when done with guidance. Overall, the GLB program is well-tolerated by participants, including those with TBI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Group Lifestyle Balance™ (GLB) program for traumatic brain injury (TBI) because it takes a holistic approach to improving health through lifestyle changes. Unlike standard care options that often focus solely on medical management or rehabilitation therapies, the GLB program encourages weight loss and increased physical activity, which are not typically emphasized in TBI care. This program is tailored specifically for individuals with TBI, offering personalized support through 22 group sessions over a year, either in-person or virtually. By integrating calorie reduction and 150 minutes of moderate exercise weekly, the GLB program aims to achieve a sustainable 5-7% weight loss, potentially enhancing overall recovery and quality of life for participants.

What evidence suggests that the Group Lifestyle Balance™ program is effective for traumatic brain injury?

Research has shown that the Group Lifestyle Balance™ (GLB) program, which participants in this trial may receive, can help people with traumatic brain injury (TBI) lose weight. One study found that individuals in the GLB-TBI group lost an average of 7.9% of their body weight over a year. Another study reported that 66.7% of participants lost more than 5% of their body weight in the same period. The program emphasizes reducing calorie intake and increasing exercise, aiming for 150 minutes of moderate activity each week. This approach has also been shown to reduce the risk of developing Type 2 diabetes. These findings suggest that the GLB program can significantly aid weight loss and improve health for people with TBI. Meanwhile, participants in the attention control group will receive education from the TBI Model Systems Knowledge Translation Center's factsheets, without a focus on weight-loss strategies. ^{1 2 3 4 6}

Who Is on the Research Team?

Simon Driver, PhD

Principal Investigator

Baylor Scott & White Institute for Rehabilitation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are overweight.

Physician approval by week 4 of program. (For those who are randomized into the attention control support group, physician approval will not be needed because information regarding physical activity and promotion will not be provided.)

Have or willing to use a smartphone or tablet

Exclusion Criteria

Pregnancy

You have been previously diagnosed with an eating disorder.

People who have participated in the study before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GLB-TBI intervention or attention control over a 12-month period, with 22 in-person or virtual group sessions.

12 months

22 visits (in-person or virtual)

App Integration

A smartphone application is integrated at week 12 to enhance participant engagement.

From week 12 onwards

Follow-up

Participants are monitored for maintenance of weight and other secondary outcomes at 18 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control Group
• Group Lifestyle Balance™

Trial Overview 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.

How Is the Trial Designed?

Group I: GLB Weight-Loss Intervention Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

The Diabetes Prevention Program Group Lifestyle Balance intervention was adapted for stroke survivors based on input from an Advisory Board, focusing on heart health, care partner involvement, and tailored physical activity and dietary modifications.

Future research is needed to evaluate the effectiveness of this modified program in preventing weight gain and reducing the risk of chronic conditions like diabetes and heart disease in individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. Driver, S., McShan, E., Swank, C., et al.[2021]

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]

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 12-month healthy lifestyle intervention for individuals with traumatic brain injury (TBI) was evaluated with 18 participants, revealing that support from staff and tracking of dietary and activity behaviors were key to perceived effectiveness.

Barriers to maintaining a healthy lifestyle included lack of motivation and challenges in meal preparation, suggesting that future programs should focus on enhancing self-regulation, providing prepared meals, and incorporating social support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a 12-month lifestyle intervention by individuals with traumatic brain injury. Douglas, M., Driver, S., Callender, L., et al.[2020]

The Group Lifestyle Balance (GLB-CVA) intervention is a modified 12-month weight loss program specifically designed for stroke survivors, addressing their unique needs and aiming to improve weight and health outcomes.

This randomized controlled trial (RCT) plans to enroll 64 patients over 18 months to evaluate the efficacy of GLB-CVA compared to a waitlist control group, contributing valuable insights into effective weight loss strategies for individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial. Driver, S., Swank, C., Froehlich-Grobe, K., et al.[2020]

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]

Citations

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

Results from a 12-month Randomized Controlled Trial Results: The GLB-TBI group (n = 27) lost 17.8 ± 41.4lbs (7.9%) over the 12-month program and the attention control group (n = 27) lost 0 ± 55.4 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03594734

Study Details | NCT03594734 | Group Lifestyle Balance™ ... The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week). Intervention/ ...

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

A randomized controlled trial protocol for people with ... The Group Lifestyle Balance (GLB) program is a self-management intervention shown to result in weight-loss (5–7%) and reduce the risk for Type 2 diabetes ...

4. msktc.org msktc.org/publications/detail/11262

Efficacy of the diabetes prevention program group lifestyle ... The 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. archives-pmr.org archives-pmr.org/article/S0003-9993(25)00224-2/abstract

Self-Efficacy and Its Impact on Weight Loss in a 12-Month ... Participants in the GLB-TBI lost an average of −15.5±16.4 lbs. over the 12-month program. 16 of the 24 participants (66.7%) lost more than 5% of their body ...

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

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)