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Trial record 4 of 291 for:    TBI | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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 25, 2018
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

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Group Lifestyle Balance™ Other: Attention Control Group Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. App Data [ Time Frame: 6 months, 12 months, and 18 months ]
    GLB TBI/Attention Control

  16. 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.

  17. 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.

  18. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Evan E Rainey, MS 214-818-2993 EvanElizabeth.Rainey@BSWHealth.org

Locations
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         
Sponsors and Collaborators
Baylor Research Institute
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Simon Driver, PhD Baylor Scott & White Institute for Rehabilitation

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03594734     History of Changes
Other Study ID Numbers: BSWRI 017-482
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baylor Research Institute:
Traumatic Brain Injury
Group Lifestyle Balance
Weight-Loss

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System