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

NCT ID: NCT03594734

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2026-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

GLB Weight-Loss Intervention

The GLB program, adapted for individuals with TBI, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week).

Group Type: EXPERIMENTAL

Group Lifestyle Balance™

Intervention Type: BEHAVIORAL

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.

Attention Control Group

The attention control group will meet at the same frequency as the GLB-TBI group over a 12-month period. The attention control group will receive education composed of the content from the TBI Model Systems Knowledge Translation Center's factsheets. No education on weight-loss strategies will be provided.

Group Type: ACTIVE_COMPARATOR

Attention Control Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 to 64 years of age
• At least 6 months post-TBI
• Moderate to severe TBI at time of injury
• BMI greater than or equal to 25
• Physician approval by week 4 of program. For those who are randomized into the attention control support group, physician approval will not be needed because information regarding physical activity and promotion will not be provided.
• Have or willing to use a smartphone or tablet

Exclusion Criteria

• Conditions in which physical activity is contraindicated
• Not fluent in the English language
• Low cognitive function
• Residing in a hospital, acute rehabilitation setting, or skilled nursing facility
• Currently taking medication for type 2 diabetes
• Pre-existing diagnosis of an eating disorder
• Pregnancy
• Previous participants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Driver, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White Institute for Rehabilitation

Locations

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, United States

Countries

United States

References

Driver S, Juengst S, Reynolds M, McShan E, Kew CL, Vega M, Bell K, Dubiel R. Healthy lifestyle after traumatic brain injury: a brief narrative. Brain Inj. 2019;33(10):1299-1307. doi: 10.1080/02699052.2019.1641623. Epub 2019 Jul 12.

Reference Type: BACKGROUND

PMID: 31296066 (View on PubMed)

Driver S, Juengst S, McShan EE, Bennett M, Bell K, Dubiel R. A randomized controlled trial protocol for people with traumatic brain injury enrolled in a healthy lifestyle program (GLB-TBI). Contemp Clin Trials Commun. 2019 Jan 31;14:100328. doi: 10.1016/j.conctc.2019.100328. eCollection 2019 Jun.

Reference Type: BACKGROUND

PMID: 30775611 (View on PubMed)

Douglas M, Driver S, Callender L, Woolsey A. Evaluation of a 12-month lifestyle intervention by individuals with traumatic brain injury. Rehabil Psychol. 2019 Feb;64(1):25-36. doi: 10.1037/rep0000253. Epub 2018 Dec 20.

Reference Type: BACKGROUND

PMID: 30570330 (View on PubMed)

Reynolds M, Driver S, Bennett M. The social network - using social media to support individuals with traumatic brain injury participating in a pilot study weight-loss program. Brain Inj. 2018;32(12):1450-1454. doi: 10.1080/02699052.2018.1496480. Epub 2018 Jul 12.

Reference Type: BACKGROUND

PMID: 30325274 (View on PubMed)

Driver S, Reynolds M, Woolsey A, Callender L, Prajapati PK, Bennett M, Kramer K. Impact of a Community-Based Healthy Lifestyle Program on Individuals With Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Nov/Dec;33(6):E49-E58. doi: 10.1097/HTR.0000000000000372.

Reference Type: BACKGROUND

PMID: 29385008 (View on PubMed)

Driver S, Reynolds M, Kramer K. Modifying an evidence-based lifestyle programme for individuals with traumatic brain injury. Brain Inj. 2017;31(12):1612-1616. doi: 10.1080/02699052.2017.1346286. Epub 2017 Jul 27.

Reference Type: BACKGROUND

PMID: 28750178 (View on PubMed)

Driver S, Reynolds M, Douglas M, Bennett M. Describing Weight Loss Attempts and Physical Activity Among Individuals With TBI Prior to Participation in a Weight-Loss Program. J Head Trauma Rehabil. 2018 Jan/Feb;33(1):E36-E43. doi: 10.1097/HTR.0000000000000327.

Reference Type: BACKGROUND

PMID: 28520676 (View on PubMed)

McShan EE, Juengst S, Douglas ME, Noorbakhsh D, Calhoun S, Bennett M, Suhalka A, Dubiel R, Driver S. Efficacy of a group-based education intervention for people with traumatic brain injury: supplementary results from a 12-month randomized controlled trial. Brain Inj. 2023 Aug 24;37(10):1205-1214. doi: 10.1080/02699052.2023.2225874. Epub 2023 Jun 24.

Reference Type: DERIVED

PMID: 37355803 (View on PubMed)

Juengst SB, McShan E, Conley M, Luu I, Driver S. Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury. J Head Trauma Rehabil. 2022 May-Jun 01;37(3):162-170. doi: 10.1097/HTR.0000000000000769. Epub 2022 Mar 15.

Reference Type: DERIVED

PMID: 35293364 (View on PubMed)

Other Identifiers

BSWRI 017-482

Identifier Type: -

Identifier Source: org_study_id