Clinical trial NCT03594734: Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)
Official title: Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Group Lifestyle Balance
Weight-Loss
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: University of Texas Southwestern Medical Center
First posted: 2018-07-20
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT).

Participants will be randomized into two group: (1) the GLB Intervention Group and (2) the Attention Control Group.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in weight
timeFrame: Baseline, 3 months, 6, months, 12 months, and 18 months
Secondary outcomes:
measure: Step Count
timeFrame: 3 months, 6 months, 12 months, and 18 months
measure: Waist and Arm Circumference
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Blood Pressure
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: HbA1c and Lipid Panel
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Risk of Diabetes
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Satisfaction with Life
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Biomarkers
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: 10 Meter Walk Test (10MWT)
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: App Feasibility and Usability using the Feasibility and Usability Survey
timeFrame: 6 months, 12 months, and 18 months
measure: Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS)
timeFrame: Baseline and 12 months
measure: Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale
timeFrame: Baseline, 12 months, and 18 months
measure: Stressful Life Events assessed by the Holmes and Rahe Stress Inventory
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: App Data
timeFrame: 6 months, 12 months, and 18 months
measure: Executive Function assessed by the Montreal Cognitive Assessment
timeFrame: Baseline, 3 months, and 12 months
measure: Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI)
timeFrame: Baseline, 3 months, and 12 months
measure: Depression assessed using the Patient Health Questionnaire-8 item
timeFrame: Baseline, 12 months, and 18 months
measure: Walk Score
timeFrame: Baseline and 12 months
measure: Behavioral Assessment
timeFrame: Baseline and 6 months
measure: General Self Efficacy
timeFrame: Baseline, 12 months, and 18 months
measure: Behavioral Risk Factor Surveillance
timeFrame: Baseline, 3, 6, 12, and 18 months.
measure: MedGem
timeFrame: Baseline
measure: Metabolic Score Calculator (MetS)
timeFrame: Baseline, 3, 6, 12, and 18 months
measure: Substance Use
timeFrame: Baseline, 12 months
measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form
timeFrame: Up to 12 months
measure: PROMIS Social Isolation Short Form 4a
timeFrame: Up to 12 months
measure: Media Questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: Baylor Scott & White Institute for Rehabilitation
name: Simon Driver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.