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

57 Participants Needed

Trial Summary

What is the purpose of this trial?

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 (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

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 data supports the effectiveness of the treatment Group Lifestyle Balance™ for traumatic brain injury?

Research shows that people with traumatic brain injury who participated in the Group Lifestyle Balance™ program lost an average of 17.8 pounds, which is about 7.9% of their body weight, compared to no weight loss in the control group. This suggests the program can effectively help manage weight in this population. ^{1 2 3 4 5}

Is the Group Lifestyle Balance Program safe for people with traumatic brain injury?

The Group Lifestyle Balance Program, which has been adapted for people with traumatic brain injury, focuses on healthy eating and physical activity. It has been used extensively with the general population and modified for specific needs, suggesting it is generally safe for humans. ^{1 2 3 5 6}

How is the Group Lifestyle Balance Program for Traumatic Brain Injury different from other treatments for TBI?

The Group Lifestyle Balance Program for Traumatic Brain Injury is unique because it adapts a proven weight-loss and healthy lifestyle program specifically for people with TBI, focusing on weight management through healthy eating and physical activity. It is delivered via telehealth, making it accessible to those who may face barriers like living in rural areas or lacking transportation. ^{1 2 3 5 7}

Research Team

Simon Driver, PhD

Principal Investigator

Baylor Scott & White Institute for Rehabilitation

Eligibility Criteria

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.

You are between 18 and 64 years old.

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.)

Exclusion Criteria

Pregnancy

You have been previously diagnosed with an eating disorder.

People who have participated in the study before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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 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 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]

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]

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. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

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

Evaluation of a 12-month lifestyle intervention by individuals with traumatic brain injury. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke. [2021]

6. Canada 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. [2020]

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

Social reintegration of TBI patients: a solution to provide long-term support. [2019]