NCT03594734

Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)

Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

Detailed description

Weight gain is common among people with TBI. Weight gain greatly increases the risk of chronic diseases such as diabetes, metabolic syndrome, pulmonary and heart disease. Approaches to weight-loss are lacking, yet necessary, due to the unique physiological and cognitive needs of persons with TBI. There is evidence that interventions that improve physical activity and healthy eating behaviors concurrently offer greatest potential for weight-loss. The Group Lifestyle Balance™ (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population, but not with people with TBI. The investigators modified the program to meet the needs of people with a TBI (GLB-TBI) and a pilot study with 20 individuals with TBI demonstrated that participation resulted in 5% weight-loss (10.2±13lbs) warranting a rigorous RCT. In addition, the investigators propose to integrate a mobile app into the GLB-TBI as 94% of pilot participants indicated that text messaging to support weight-loss would have been "very helpful" to boost motivation. The proposed study consists of four specific aims. Specific Aim 1: To examine the efficacy of the GLB-TBI compared to an attention control at 3, 6, 12, and 18 months from baseline using a randomized controlled trial. Specific Aim 2: To examine participant compliance to GLB-TBI intervention components and its association with their outcomes: Aim 2.1: To determine participant compliance with specific components of the GLB-TBI, including: (1) session attendance (2) self-monitoring of dietary and activity behaviors and (3) activity tracking of step count through accelerometer data. Aim 2.2: To determine if compliance with the GLB-TBI is associated with improvement in primary (weight) and secondary outcomes (step count; waist circumference; blood pressure; HbA1c and lipid panel; functional measures; and quality of life). Specific Aim 3: To assess feasibility (compliance, usability) of adding a smartphone application at week 12 of the GLB-TBI program and attention control condition to enhance participant engagement. Specific Aim 4: Ascertain maintenance of primary (weight) and additional secondary outcomes (step count; waist circumference; blood pressure; HbA1c and lipid panel; risk of diabetes; and quality of life), compliance with and effect of the GLB-TBI and Attention Control App at 18 months. Aim 4.1: To evaluate and integrate deep phenotype profiling (e.g. proteomics, metabolomics) and correlate findings with rehabilitation therapy and outcomes in patients with TBI.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Group Lifestyle Balance™	The Group Lifestyle Balance™ (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB program curriculum used in this RCT will be adapted for individuals with TBI.
OTHER	Attention Control Group	The attention control group will receive the same contact or "attention" as the intervention group. The attention control group will meet at the same frequency as the intervention group. Education for the sessions will be composed of content from the TBI Model Systems Knowledge Translation Center's factsheets. General topics will include discussion on (1) healthy brain and effects of TBI on cognitive, emotional, and behavioral functioning, (2) expectations for recovery, (3) preventative and management strategies for common TBI sequela (e.g. inability and impulsivity), (4) stress management, (5), signs and symptoms of depression, and (6) strategies for effective communication.

Timeline

• Start date: 2019-01-08
• Primary completion: 2022-12-30
• Completion: 2026-12-30
• First posted: 2018-07-20
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States