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

NCT03594734 | Active Not Recruiting

• 1 other identifier: BSWRI 017-482
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Group Lifestyle Balance; Weight-Loss

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Weight will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g. walker; wheelchair)

  Baseline, 3 months, 6, months, 12 months, and 18 months

Secondary Outcomes (28)

• Step Count

  3 months, 6 months, 12 months, and 18 months

• Waist and Arm Circumference

  Baseline, 3 months, 6 months, 12 months, and 18 months

• Blood Pressure

  Baseline, 3 months, 6 months, 12 months, and 18 months

• HbA1c and Lipid Panel

  Baseline, 3 months, 6 months, 12 months, and 18 months

• Risk of Diabetes

  Baseline, 3 months, 6 months, 12 months, and 18 months

Study Arms (2)

GLB Weight-Loss Intervention

EXPERIMENTAL

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).

Behavioral: Group Lifestyle Balance™

Attention Control Group

ACTIVE COMPARATOR

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.

Other: Attention Control Group

Interventions

Group Lifestyle Balance™ 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.

GLB Weight-Loss Intervention

Attention Control Group 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.

Attention Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

Related Publications (9)

• 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.

  PMID: 31296066 BACKGROUND

• 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.

  PMID: 30775611 BACKGROUND

• 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.

  PMID: 30570330 BACKGROUND

• 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.

  PMID: 30325274 BACKGROUND

• 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.

  PMID: 29385008 BACKGROUND

• 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.

  PMID: 28750178 BACKGROUND

• 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.

  PMID: 28520676 BACKGROUND

• 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.

  PMID: 37355803 DERIVED

• 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.

  PMID: 35293364 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Weight Loss

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Driver, PhD

  Baylor Scott & White Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT). Participants will be randomized into two group: (1) the GLB Intervention Group and (2) the Attention Control Group.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 20, 2018
• Study Start: January 8, 2019
• Primary Completion: December 30, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)