Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/10/2019 |
| Start Date: | January 8, 2019 |
| End Date: | September 30, 2022 |
| Contact: | Evan E Rainey, MS |
| Email: | EvanElizabeth.Rainey@BSWHealth.org |
| Phone: | 214-818-2993 |
Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury
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.
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.
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.
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.
Inclusion Criteria:
- 18 to 65 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
- 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
- Diagnosis of diabetes or currently taking diabetes medication
- Pre-existing diagnosis of an eating disorder
- Pregnancy
We found this trial at
1
site
909 North Washington Avenue
Dallas, Texas 75246
Dallas, Texas 75246
Principal Investigator: Simon Driver, PhD
Phone: 214-818-2993
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