Active — Not RecruitingNot Applicable

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

United States85 participantsStarted 2023-05-25

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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 provided by the research team) Exclusion Criteria: * 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

What they're measuring

Change in Weight

Timeframe: Baseline, 3, 6, and 12 months

Trial details

NCT IDNCT05699772

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31