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

摘要

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.