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

Last updated: October 3, 2025
Sponsor: Baylor Research Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Weight Loss

Memory Loss

Treatment

Brain Health Group (BHG)

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

Clinical Study ID

NCT05699772
BSW IRB #022-356
  • Ages 18-80
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 providedby the research team)

Exclusion

Exclusion Criteria:

  • Contraindications to physical activity (e.g., uncontrolled hypertension, unstableangina, 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

Study Design

Total Participants: 85
Treatment Group(s): 2
Primary Treatment: Brain Health Group (BHG)
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Baylor Scott & White Research Institute

    Dallas, Texas 75204
    United States

    Site Not Available

  • Baylor Scott & White Research Institute

    Dallas 4684888, Texas 4736286 75204
    United States

    Site Not Available

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