SEARCHOTHERneurology, endocrinology

other·neurology, endocrinology, public health, clinical trial, internal medicine·PMC10382627

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

Contemporary Clinical Trials Communications · 7 authors, 3 centres

AI SUMMARY

FIDELITY 100%

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

“

TL;DR

This is a protocol for a randomized controlled trial testing a telehealth-delivered diabetes prevention program for individuals with traumatic brain injury.

Full summary

730 CHARS

This paper outlines the protocol for a randomized controlled trial (RCT) evaluating a telehealth-delivered diabetes prevention program (tGLB-TBI) for individuals with traumatic brain injury (TBI). The intervention is a modified, evidence-based Diabetes Prevention Program delivered via telehealth to address obesity and diabetes risk post-TBI, which are common and problematic sequelae. Primary and secondary outcomes, including weight, HbA1c, lipids, blood pressure, and quality of life, will be collected at baseline, 3, 6, and 12 months via local labs and telephonic interviews. Analyses will use linear mixed effects models to compare changes over time between groups. The protocol emphasizes broadening access to the program.

STUDY TYPE

other

SPECIALTY

neurology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10382627

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

Contemporary Clinical Trials Communications

READ THE FULL PAPER

ABSTRACT

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: Exercise, Diet, Weight loss, Virtual, Intervention

CITATION EXPORT

Simon Driver, Evan Elizabeth McShan, Monica Bennett et al.. A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI). Contemporary Clinical Trials Communications. (2023). https://doi.org/10.1016/j.conctc.2023.101191

AUTHORS

7 · 3 CENTRES

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

aNorth Texas TBI Model System, USA
bBaylor Scott and White Research Institute, 3434 Live Oak Street, Dallas, TX, 75204, USA
cBaylor Scott and White Institute for Rehabilitation, 909 N. Washington, Dallas, TX, 75246, USA