Group Lifestyle Balance Program for Traumatic Brain Injury

Overseen by Simon Driver, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor Research Institute

No Placebo Group

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.

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.

Treatment Details

Interventions

• Attention Control Group (Other)
• Group Lifestyle Balance™ (Behavioral Intervention)

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+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

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