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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
At least 6 months post-TBI
BMI greater than or equal to 25
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 12, and 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be at least 6 months past a traumatic brain injury.
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You are overweight.
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You are between 18 and 64 years old.
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You have a moderate to severe traumatic brain injury.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weight
Secondary outcome measures
10 Meter Walk Test (10MWT)
6 Minute Walk Test (6MWT)
App Data
+25 more

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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterOTHER
1,039 Previous Clinical Trials
1,048,042 Total Patients Enrolled
Baylor Research InstituteLead Sponsor
198 Previous Clinical Trials
202,695 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
69 Previous Clinical Trials
8,320 Total Patients Enrolled

Media Library

Group Lifestyle Balance™ Clinical Trial Eligibility Overview. Trial Name: NCT03594734 — N/A
Traumatic Brain Injury Research Study Groups: Attention Control Group, GLB Weight-Loss Intervention
Traumatic Brain Injury Clinical Trial 2023: Group Lifestyle Balance™ Highlights & Side Effects. Trial Name: NCT03594734 — N/A
Group Lifestyle Balance™ 2023 Treatment Timeline for Medical Study. Trial Name: NCT03594734 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to individuals aged 55 and older?

"This clinical trial requires patients to fall within an age bracket of 18-64, with 156 trials for individuals below the legal adult age limit and 702 trials targeting those over 65."

Answered by AI

Is it possible for me to participate in this clinical trial?

"This clinical trial seeks 57 adults between the ages of 18 to 64 who have suffered a traumatic brain injury for at least 6 months. Other requirements include having Body Mass Index (BMI) greater than 25 and physician approval by week 4, with exception being made for those placed into attention control groups as no physical activity information will be provided. Additionally, participants must own or be willing to use a smartphone or tablet."

Answered by AI

Is this medical trial still recruiting participants?

"According to the clinicaltrials.gov database, this particular medical trial is not currently recruiting patients due to it's last edit date of July 18th 2022 and its original posting date from August 1st 2019. However, there are still 901 other studies actively searching for participants at present."

Answered by AI
Recent research and studies
~9 spots leftby Mar 2025