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Traumatic Brain InjurytGLB-TBINCT05699772

Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI

A study testing Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) and Brain Health Group (BHG) in people with Traumatic Brain Injury, run by Baylor Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) and Brain Health Group (BHG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
25 May 2023to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years of age
  • Greater than or equal to 6 months post traumatic brain injury (TBI)
  • Moderate to severe TBI at time of injury
  • Body Mass Index greater than or equal to 25
  • Able to participate in physical activity
  • Willing to use a tablet/computer/smartphone (either personal device or one provided by the research team)

Who cannot join

  • Contraindications to physical activity (e.g., uncontrolled hypertension, unstable angina, severe joint disease, uncontrolled vertigo/dizziness)
  • Not fluent in the English language
  • Low cognitive function
  • Residing in a hospital, acute rehabilitation facility, or skilled nursing facility
  • Diagnosed with or taking medications for Type 2 diabetes
  • Self-reported pregnancy
  • Pre-existing diagnosis of an eating disorder

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

Other trials in United States

About this study

The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample.

To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.

Read the detailed description

Diabetes Prevention Program Group Lifestyle Balance Program (DPP-GLB): The DPP-GLB is a 12-month, evidence-based, CDC-accredited weight-loss intervention designed for delivery in group-based, community settings, and has resulted in weight loss in a variety of settings such as community centers, churches, worksites, and healthcare settings. Alternate modes of delivery (e.g., DVD, telehealth, telephone call) have also proven efficacious. The primary goal of the DPP-GLB intervention is to help the participant achieve and maintain a 5-7% weight loss by following federal guidelines for physical activity participation (safe and progressive increase to achieve 150 minutes of moderate intensity activity each week) and dietary recommendations.

DPP-GLB for individuals with TBI: In 2015 we modified the DPP-GLB with a group of stakeholders to meet the unique needs of individuals with TBI (GLB-TBI). We pilot tested the GLB-TBI in a group of 18 individuals with TBI who lost -10.2±13lbs (-5% weight-loss) over 12 months. These results warranted rigorous testing.

Efficacy of the GLB-TBI using an RCT: We then completed an in-person randomized controlled trial (RCT) to assess the efficacy of the GLB-TBI compared to an attention control (NCT03594734) for Dallas residents after TBI. Individuals in the GLB-TBI group (n=27) lost -17.8±41.4lbs (-7.9%) over the 12-month program and the attention control group (n=28) lost 0±55.4lbs (0%). The GLB-TBI group also had significant improvements in diastolic blood pressure, waist circumference, triglycerides, and HDL cholesterol. As a result of this strong evidence, our GLB-TBI curriculum was recognized by the CDC as an evidence-based approach to in-person weight-loss.

The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample.

To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.

Being tested
Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI), Brain Health Group (BHG)
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI)Behavioural

    The GLB-TBI was modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) by a group of stakeholders using a community based participatory research approach. The GLB-TBI is modified for people with Traumatic Brain Injury and addresses their unique weight loss and healthy lifestyle needs.

  • Brain Health Group (BHG)Behavioural

    The BHG was developed by researchers and clinicians at Baylor Scott \& White Institute for Rehabilitation.

Study groups in NCT05699772
Study groupRoleWhat they receive
Telehealth GLB-TBI (tGLB-TBI)ExperimentalThe goal of the tGLB-TBI program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach: 1. 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. 2. 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).
Receives: Behavioral: Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI)
Brain Health Group (BHG)Active comparatorThe 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).
Receives: Behavioral: Brain Health Group (BHG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Weight will be obtained at a lab local to the participant based on their preference. Weight for participants randomized to the GLB-TBI will also be captured via self-weighing using provided BodyTrace Smart Scale, which include cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with in-person weighing in previous weight management research.Scales will be setup by our team before being mailed to participants with instructions for use.

    Measured: Baseline, 3, 6, and 12 months

Secondary outcomes (14)
  1. Change in Hemoglobin A1c (HbA1c)

    Hemoglobin A1c will be obtained at a lab local to the participant based on their preference.

    Measured: Baseline, 3, 6, and 12 months

  2. Change in Lipid Panel

    Total cholesterol, HDL, LDL, and triglycerides will be obtained at a lab local to the participant based on their preference

    Measured: Baseline, 3, 6, and 12 months

  3. Change in Arm Circumference

    Arm circumference will be measured at the mid-upper arm at a lab local to the participant based on their preference.

    Measured: Baseline, 3, 6, and 12 months

  4. Change in Waist Circumference

    Waist circumference will be measured at the umbilicus at a lab local to the participant based on their preference.

    Measured: Baseline, 3, 6, and 12 months

  5. Change in Blood Pressure

    Measured using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded at a lab local to the participant based on their preference.

    Measured: Baseline, 3, 6, and 12 months

  6. Change in 8-Year Diabetes Risk

    The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, BMI, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials.

    Measured: Baseline, 3, 6, and 12 months

  7. Change in Metabolic Syndrome Severity Score

    Metabolic Syndrome is a cluster of cardiovascular risk factors that include abdominal obesity (large waist circumference, high BMI), high blood pressure, high triglycerides, low HDL cholesterol and high fasting blood sugar. Individuals who have ≥3 of these risk factors have metabolic syndrome, placing them at greater risk of developing heart disease and diabetes. As metabolic syndrome is sensitive to lifestyle change, the metabolic syndrome severity score calculator is used to determine risk for future cardiovascular disease compared to the US population. Risk scores below 0 indicate a lower degree of metabolic syndrome risk than the average US adult; scores above 0 are associated with greater risk for disease. A score of 1 indicates risk is higher than 84.1% of US adults and a score of 2 is higher than 97.7% of US adults. Z scores are calculated for BMI and waist circumference.

    Measured: Baseline, 3, 6, and 12 months

  8. Change in Dietary Change

    The DPP-GLB program itself utilizes food logs as an intervention behavioral tool, however, to further evaluate intervention efficacy we will also assess dietary change at each assessment period. 24-hour dietary recalls will be collected with the latest version of the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool 1-day prior to the telephonic follow-up. This free online platform (https://epi.grants.cancer.gov/asa24/#what; uses interactive multi-pass methodology68(gold-standard in dietary assessment) and provides an overall diet quality score, the Healthy Eating Index (available online through the NCI website [https://epi.grants.cancer.gov/asa24/resources/hei.html] and aligns with federal recommendations and guidelines).

    Measured: Baseline, 3, 6, and 12 months

  9. Change in Neighborhood Environment Walkability Scale (NEWS)

    The Neighborhood Environment Walkability Scale (NEWS) assesses participants' perception of neighborhood features related to physical activity and grocery shopping, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Questions are rated on a 4-point Likert scale with higher scores signifying greater perceived walkability. Scores provide insight into environmental barriers faced, are sensitive to behavior change, and can be used as a covariate for weight-loss. This measure will be delivered telephonically.

    Measured: Baseline, 3, 6, and 12 months

  10. Change in Healthy Eating and Physical Activity

    The Behavioral Risk Factor Surveillance System (BRFSS) is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items. For this study, we will capture minutes of self-reported physical activity (higher numbers signify more physical activity and better outcome) and number of whole fruits/vegetables consumed each day (higher numbers mean better outcome). This measure will be administered telephonically.

    Measured: Baseline, 3, 6, and 12 months

  11. Change in Self-Rated Abilities for Health Practice (SRAHP)

    The SRAHP includes 28 items to assess health behaviors among people with disabilities and yields a total Health Practices Score plus 4 subscale scores (Exercise, Nutrition, Health Practices, and Psychological Well Being). Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher self-efficacy for the health behaviors. This measure will be administered telephonically.

    Measured: Baseline, 3, 6, and 12 months

  12. Change in Quality of Life After Brain Injury - Overall Scale

    The Quality of Life After Brain Injury - Overall Scale (QOLIBRI-OS) is a six-item self-report questionnaire addressing how satisfied individuals are with aspects of their functioning (physical; cognitive; emotional; participation; social life; future prospects). Answers are on a 5-point Likert scale and the sum of all items are converted to a percentage scale from 0-100. The QOLIBRI-OS has excellent reliability and internal consistency. This measure will be administered telephonically.

    Measured: Baseline, 3, 6, and 12 months

  13. Change in Telehealth Usability Questionnaire (TUQ)

    The Telehealth Usability Questionnaire (TUQ) is a validated assessment that measures 5 usability factors of telehealth (usefulness, ease of use, effectiveness, reliability, and satisfaction). 21 items are scored on level of agreement from 1-7, with higher scores indicating greater agreement. All subscales have good to excellent reliability (α=.79-.92). This measure will be administered telephonically.

    Measured: Baseline, 3, 6, and 12 months

  14. Change in Exit Survey

    Participants will be asked to complete an exit survey at the 12-month assessment. This survey will ask about participant experience in, and satisfaction with, the GLB-TBI telehealth program and suggestions for improvement. The survey will be emailed to participants via a secure link.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start25 May 2023
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05699772
Sponsor's protocol ID
BSW IRB #022-356
Acronym
tGLB-TBI
Status last verified
Oct 2025
First submitted
13 Jan 2023
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD requests can be made to the Principal Investigator via email (Evan.McShan@BSWHealth.org).

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) and Brain Health Group (BHG) in people with Traumatic Brain Injury, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: Baseline, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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