Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)
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|ClinicalTrials.gov Identifier: NCT03594734|
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: Group Lifestyle Balance™ Other: Attention Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|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.
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: 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, 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™
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.
Active Comparator: 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.
Other: 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.
- Change in weight [ Time Frame: Baseline, 3 months, 6, months, 12 months, and 18 months ]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)
- Step Count [ Time Frame: 3 months, 6 months, 12 months, and 18 months ]The Garmin Vivofit will be worn for the study duration to measure physical activity data.
- Waist Circumference [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]Waist circumference will be measured at the umbilicus and mild-upper arm circumference following American College of Sports Medicine guidelines.
- Blood Pressure [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded.
- HbA1c and Lipid Panel [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]Fasting venous sample will be obtained for blood glucose, HDL/LDL, cholesterol, and triglyceride level.
- Risk of Diabetes [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials.
- Quality of Life (QOL) assessed by The Quality of Life After Brain Injury - Overall Scale (QOLIBRI-OS) [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]The Quality of Life After Brain Injury - Overall Scale (QOLIBRI-OS) is a six-item self-report questionnaire addressing how satisfied individuals are with aspects of their functioning (physical; cognitive; emotional; participation; social life; future prospects). Answers are on a 5-point Likert scale and the sum of all items are converted to a percentage scale from 0-100, with 100 representing greater QOL.
- Biomarkers [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]TSH, Cortisol, IL-6, THNF, BDNF, IGF, and VEGF will be collected.
- 10 Meter Walk Test (10MWT) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.
- 6 Minute Walk Test (6MWT) [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]Assesses distance walked (rolled for wheelchair users) over 6 minutes as a sub-maximal test of aerobic capacity.
- Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]Social Support for Diet and Exercise Behaviors Scale is a 23-item survey including four subscales: support for healthy eating (5 items); support for physical activity (11 items); social undermining for healthy eating (5 items) and physical activity (2 items). Each item is rated on a scale of 1 to 5 (1 none; 5 very often), with respondents asked to rate support from family, friends, and coworkers. Higher scores represent greater support and internal consistency ranged from Cronbach's α 0.72-0.76.
- App Feasibility and Usability using the Feasibility and Usability Survey [ Time Frame: 6 months, 12 months, and 18 months ]The Feasibility and Usability survey includes 14 items that assesses the participant's subjective experience with the App, level of difficulty, prompting sequence, length, and understanding. Scores above 3 on the scale (1 [totally disagree] - 5 [totally agree]) indicate that the App was easy to use.
- Perception of Neighborhood Design Features assessed by the Neighborhood Environment Walkability Scale (NEWS) [ Time Frame: Baseline and 12 months ]NEWS assesses residents' perception of neighborhood design features related to physical activity, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction.
- Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale [ Time Frame: Baseline, 12 months, and 18 months ]Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
- Stressful Life Events assessed by the Holmes and Rahe Stress Inventory [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions (Holmes & Rahe, 1967). Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.
- App Data [ Time Frame: 6 months, 12 months, and 18 months ]GLB TBI/Attention Control
- Executive Function assessed by the Montreal Cognitive Assessment [ Time Frame: Baseline, 3 months, and 12 months ]The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations.The MOCA has also been used in the TBI population.111 Each item on the MOCA is allocated a set of points adding up to 30. The MOCA will be administered at 3 timepoints (baseline, 3 months and 12 months) using 3 different versions of the instrument.
- Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI) [ Time Frame: Baseline, 3 months, and 12 months ]Self-Report Habit Index measures self-reported perceptions of habit strength for an identified behavior. The measure has high internal reliability across four studies. The measure consists of 12 items using a 7-point Likert scale ranging from "completely disagree" to "completely agree", with higher scores representing greater perception of habit strength.
- Depression assessed using the Patient Health Questionnaire-8 item [ Time Frame: Baseline, 12 months, and 18 months ]The PHQ-8 is a brief self-report measure of major depressive disorder, derived from the PHQ-9 by removing the last question regarding suicide assessment.It is considered to be a valid measure of depression for population-based studies and clinical populations, and has been used in studies of patients with physical injury. Frequency of symptoms during the last 2 weeks is assessed on a 0 (not at all) to 3 (nearly every day) scale. A cut-off score of 10 or greater is considered diagnostic for current depression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594734
|Contact: Evan E Rainey, MS||214-818-2993||EvanElizabeth.Rainey@BSWHealth.org|
|United States, Texas|
|Baylor Scott & White Institute for Rehabilitation||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Evan E Rainey, MS 214-818-2993 EvanElizabeth.Rainey@BSWHealth.org|
|Principal Investigator: Simon Driver, PhD|
|Sub-Investigator: Rosmary Dubiel, DO|
|Sub-Investigator: Shannon Juengst, PhD|
|Principal Investigator:||Simon Driver, PhD||Baylor Scott & White Institute for Rehabilitation|