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一项针对参与远程医疗糖尿病预防项目(tGLB-TBI)的创伤性脑损伤患者的随机对照试验方案。

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

作者信息

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

机构信息

North Texas TBI Model System, USA.

Baylor Scott and White Research Institute, 3434 Live Oak Street, Dallas, TX, 75204, USA.

出版信息

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

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.

摘要

创伤性脑损伤(TBI)后的肥胖率很高,与普通人群相比,其发病(糖尿病、高血压)和死亡风险更高。针对这一人群需要有循证干预措施,而我们对糖尿病预防计划团体生活方式平衡(GLB-TBI)进行调整并检验其效果的工作很有前景。我们最近的随机对照试验纳入了57名患有TBI的成年人,他们亲自完成了GLB-TBI,与注意力控制组(减重0%)相比,体重减轻了17.8±16.4磅(体重的7.9%)。为了扩大该干预措施的可及性,我们将开展一项随机对照试验,在3年时间里招募88名参与者,以评估远程医疗服务(tGLB-TBI)的效果。研究结果将提供一个可扩展的远程医疗减肥项目,全国的临床医生和社区工作者都可以用它来帮助TBI患者减肥并改善健康状况。长期目标是减少健康不平等现象,并将项目推广到因环境障碍(包括居住在农村或缺乏交通工具)而无法获得服务的TBI患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78e6/10382627/a6910afd28af/gr1.jpg

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