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

Baylor Scott and White Health (BSWH)

Status: Active, not recruiting

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Group Lifestyle Balance™; Other: Attention Control Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03594734

BSWRI 017-482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

GLB Weight-Loss Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Group Lifestyle Balance™

Attention Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Attention Control Group