← Back to Search

Group Lifestyle Balance Program for Traumatic Brain Injury

N/A

Waitlist Available

Led By Simon Driver, PhD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a GLB program can help people with TBI lose weight and improve other outcomes, measured at 3, 6, 12, and 18 months.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but will vary based on individual health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in weight

Secondary study objectives

10 Meter Walk Test (10MWT)

6 Minute Walk Test (6MWT)

App Data

+25 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GLB Weight-Loss InterventionExperimental Treatment1 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 GroupActive Control1 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.

Do I qualify?Apply below to find out