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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03594734
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE January 8, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03594734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • 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. Each risk predictor is assigned points ranging from 2 -10. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.
  • Satisfaction with Life [ Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months ]
    Satisfaction with life will be measured using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7-strongly agree to 1-strongly disagree. Scores are added together and a total score is calculated, with higher scores signifying higher satisfaction with life and lower scores signifying lower satisfaction with life.
  • 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.
  • Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS) [ Time Frame: Baseline and 12 months ]
    NEWS assesses residents' perception of neighborhood design features, categorized into subscales 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. Subscales are scored as a mean of items. Higher scores denote higher walkability.
  • 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. Each item on the MOCA is allocated a set of points adding up to 30.
  • 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
  • Walk Score [ Time Frame: Baseline and 12 months ]
    Walk Score is publically available and measures walkability of any address using a patented system. Fore each address, Walk Score analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenities. Scores are given on a scale of 0 to 100.
  • Behavioral Assessment [ Time Frame: Baseline and 6 months ]
    The BAST is a 47 item, theoretically grounded, validated survey of behavioral and emotional symptoms for community-based adults with TBI. This assessment is a shortened version of the validated 77-item survey, with questions related to environmental stressors and mood removed due to repetitiveness to other questions in survey packet. Responses are asked over the past two weeks using an ordinal scale from 0 "rarely" to 5 "very often." There are 6 subscales: Negative Affect, Substance Use, Executive Function, Fatigue, Impulsivity, and Maladaptive Coping. Higher scores indicate more symptoms in those domains. This measure will be used to characterize behavioral/emotional symptoms and to explore whether these are factors that influence
  • General Self Efficacy [ Time Frame: Baseline, 12 months, and 18 months ]
    The ten items from the General Self-Efficacy Scale (GSE) are deigned to examine goal-setting, effort investment, persistence in face of barriers and recovery from setbacks as constructs of perceived self-efficacy (Schwarzer & Jerusalem, 2013). The total score is the sum ranging from 10-40 and the instrument has been normed against the U.S. Adult population with a mean score of 29.48.
  • Behavioral Risk Factor Surveillance [ Time Frame: Baseline, 3, 6, 12, and 18 months. ]
    The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.
  • MedGem [ Time Frame: Baseline ]
    This is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)
Official Title  ICMJE Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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)
Primary Purpose: Other
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Group Lifestyle Balance™
  • 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.
    Intervention: Other: Attention Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
66
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Evan E Rainey, MS 214-818-2993 EvanElizabeth.Rainey@BSWHealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594734
Other Study ID Numbers  ICMJE BSWRI 017-482
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE
  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • University of Texas Southwestern Medical Center
Investigators  ICMJE
Principal Investigator: Simon Driver, PhD Baylor Scott & White Institute for Rehabilitation
PRS Account Baylor Research Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP