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Behavioral Intervention

Telehealth Weight-loss Program for Traumatic Brain Injury (tGLB-TBI Trial)

N/A
Recruiting
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, and 12 months
Awards & highlights

tGLB-TBI Trial Summary

This trial will test a telehealth weight-loss program to help people with Traumatic Brain Injury (TBI) lose weight and improve their health.

Who is the study for?
This trial is for adults aged 18-80 with moderate to severe TBI, a BMI of 25 or higher, and at least 6 months post-injury. Participants must be able to exercise and willing to use digital devices for telehealth. It excludes those with conditions limiting physical activity, non-English speakers, low cognitive function, institutional residents, diabetes patients, pregnant individuals or those with eating disorders.Check my eligibility
What is being tested?
The study tests the effectiveness of a weight-loss program adapted for people with TBI (tGLB-TBI) delivered via telehealth against a Brain Health Group (BHG). The aim is to make this intervention widely accessible and improve health outcomes in the underserved population after TBI.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical responses to diet change or increased physical activity such as muscle soreness or fatigue. Specific side effects will depend on individual health conditions.

tGLB-TBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, and 12 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
Change in 8-Year Diabetes Risk
Change in Arm Circumference
Change in Blood Pressure
+11 more

tGLB-TBI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth GLB-TBI (tGLB-TBI)Experimental Treatment1 Intervention
The goal of the tGLB-TBI program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach: Physical activity: This is based upon recommendations by the American Heart Association and the American College of Sports Medicine (ACSM) to achieve 150 minutes of moderate intensity activity each week. Walking is the primary activity recommended. Healthy eating: Based on United States Department of Agriculture guidelines, the GLB emphasizes healthy eating patterns and tracking dietary intake. The tGLB-TBI was modified from the DPP-GLB and is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).
Group II: Brain Health Group (BHG)Active Control1 Intervention
The Brain Health Group (BHG) meets at the same frequency as the GLB-TBI (i.e., 22 group-based sessions, 12 weekly, 4 bi-monthly, and 6 monthly).The focus of the BHG is on brain health education, self-management, and problem-solving and the BHG did not receive any education on weight-loss strategies. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,138 Total Patients Enrolled
North Texas Traumatic Brain Injury Model System (NTX-TBIMS)UNKNOWN
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,041 Total Patients Enrolled

Media Library

Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05699772 — N/A
Traumatic Brain Injury Research Study Groups: Telehealth GLB-TBI (tGLB-TBI), Brain Health Group (BHG)
Traumatic Brain Injury Clinical Trial 2023: Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) Highlights & Side Effects. Trial Name: NCT05699772 — N/A
Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05699772 — N/A

Frequently Asked Questions

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

Does this clinical research include participants aged 55 or older?

"This medical experiment is open to those aged 18-64."

Answered by AI

Is my eligibility to participate in this research investigation confirmed?

"This medical trial is accepting 88 people aged 18-64 who have experienced a traumatic brain injury at least 6 months ago and currently suffer from moderate to severe TBI. The body mass index must be 25 or more, they need to be physically active enough for the study, own their own device (or use one provided by research team) as well as being willing to participate in the trial."

Answered by AI

Are enrollments still open for this scientific experiment?

"Based on the information available from clinicaltrials.gov, this research endeavour is not actively seeking enrolment at this time. Initially posted in mid-January of 2021 and last updated a week later, there are currently 517 other medical trials that have open spots for potential participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor Scott & White Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Recent research and studies
clinicaltrials.govStudy
Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
Simon Driver 2023. "Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05699772.
All > Weight Loss Dallas
~59 spots leftby Aug 2026
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