A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI)

Simon Driver; Evan Elizabeth McShan; Monica Bennett; Stephanie Calhoun; Librada Callender; Chad Swank; Rosemary Dubiel

doi:10.1016/j.conctc.2023.101191

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI)

Contemp Clin Trials Commun. 2023 Jul 17:35:101191. doi: 10.1016/j.conctc.2023.101191. eCollection 2023 Oct.

Authors

Simon Driver^{1

2

3}, Evan Elizabeth McShan^{1

2}, Monica Bennett^{1

2}, Stephanie Calhoun^{1

2}, Librada Callender^{1

2}, Chad Swank^{1

2

3}, Rosemary Dubiel^{1

2}

Affiliations

¹ North Texas TBI Model System, USA.
² Baylor Scott and White Research Institute, 3434 Live Oak Street, Dallas, TX, 75204, USA.
³ Baylor Scott and White Institute for Rehabilitation, 909 N. Washington, Dallas, TX, 75246, USA.

Abstract

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. 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. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation.

Keywords: Diet; Exercise; Intervention; Virtual; Weight loss.