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A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI).

ABSTRACT: Weight gain is prevalent among people with traumatic brain injury (TBI) and may be attributable to environmental or injury-specific factors such as mobility impairment, endocrine dysfunction, behavioral and emotional disorders, and sensory loss. Few weight management programs exist to meet the unique needs of this population. Researchers modified a nationally recognized, evidence-based weight-loss program, Group Lifestyle Balance™ (GLB), to address the needs of over-weight and obese people post TBI (GLB-TBI). This current randomized controlled trial (RCT) examines the efficacy of the GLB-TBI on weight and secondary outcomes compared to an attention control educational support group. Furthermore, researchers have developed a mobile technology app to further engage participants in the program. This RCT will enroll and randomize 66 participants over a two-year period. It is anticipated that findings from this current RCT will contribute to the knowledge and evidence for an effective weight-loss intervention among this underserved population, with a goal of achieving full recognition by the Centers for Disease Control and Prevention-National Diabetes Prevention Program and subsequent Center for Medicare and Medicaid Services reimbursement for participation.

SUBMITTER: Driver S

PROVIDER: S-EPMC6365803 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI).

Driver Simon S Juengst Shannon S McShan Evan Elizabeth EE Bennett Monica M Bell Kathleen K Dubiel Rosemary R

Contemporary clinical trials communications 20190131

Weight gain is prevalent among people with traumatic brain injury (TBI) and may be attributable to environmental or injury-specific factors such as mobility impairment, endocrine dysfunction, behavioral and emotional disorders, and sensory loss. Few weight management programs exist to meet the unique needs of this population. Researchers modified a nationally recognized, evidence-based weight-loss program, Group Lifestyle Balance™ (GLB), to address the needs of over-weight and obese people post ...[more]

PMID: 30775611

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Project description:Introduction and aimsTraumatic brain injury (TBI) often results in persistent disability, due particularly to cognitive impairments. Outcomes remain difficult to predict but appear to relate to axonal injury. Several new approaches involving fluid and neuroimaging biomarkers show promise to sensitively quantify axonal injury. By assessing these longitudinally in a large cohort, we aim both to improve our understanding of the pathophysiology of TBI, and provide better tools to predict clinical outcome.Methods and analysisBIOmarkers of AXonal injury after TBI is a prospective longitudinal study of fluid and neuroimaging biomarkers of axonal injury after moderate-to-severe TBI, currently being conducted across multiple European centres. We will provide a detailed characterisation of axonal injury after TBI, using fluid (such as plasma/microdialysate neurofilament light) and neuroimaging biomarkers (including diffusion tensor MRI), which will then be related to detailed clinical, cognitive and functional outcome measures. We aim to recruit at least 250 patients, including 40 with cerebral microdialysis performed, with serial assessments performed twice in the first 10 days after injury, subacutely at 10 days to 6 weeks, at 6 and 12 months after injury.Ethics and disseminationThe relevant ethical approvals have been granted by the following ethics committees: in London, by the Camberwell St Giles Research Ethics Committee; in Policlinico (Milan), by the Comitato Etico Milano Area 2; in Niguarda (Milan), by the Comitato Etico Milano Area 3; in Careggi (Florence), by the Comitato Etico Regionale per la Sperimentazione Clinica della Regione Toscana, Sezione area vasta centro; in Trento, by the Trento Comitato Etico per le Sperimentazioni Cliniche, Azienda Provinciale per i Servizi Sanitari della Provincia autonoma di Trento; in Lausanne, by the Commission cantonale d'éthique de la recherche sur l'être humain; in Ljubljana, by the National Medical Ethics Committee at the Ministry of Health of the Republic of Slovenia. The study findings will be disseminated to patients, healthcare professionals, academics and policy-makers including through presentation at conferences and peer-reviewed publications. Data will be shared with approved researchers to provide further insights for patient benefit.Trial registration numberNCT03534154.

Dataset Information

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI).

Publications

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI).

Similar Datasets

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