Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in weight
时间窗: 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)
次要结局
- 10 Meter Walk Test (10MWT)(Baseline, 3 months, 6 months, and 12 months)
- Waist and Arm Circumference(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Blood Pressure(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Step Count(3 months, 6 months, 12 months, and 18 months)
- Risk of Diabetes(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Satisfaction with Life(Baseline, 3 months, 6 months, 12 months, and 18 months)
- HbA1c and Lipid Panel(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Biomarkers(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Executive Function assessed by the Montreal Cognitive Assessment(Baseline, 3 months, and 12 months)
- Walk Score(Baseline and 12 months)
- Behavioral Assessment(Baseline and 6 months)
- 6 Minute Walk Test (6MWT)(Baseline, 3 months, 6 months, and 12 months)
- Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS)(Baseline and 12 months)
- Depression assessed using the Patient Health Questionnaire-8 item(Baseline, 12 months, and 18 months)
- Behavioral Risk Factor Surveillance(Baseline, 3, 6, 12, and 18 months.)
- Substance Use(Baseline, 12 months)
- Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale(Baseline, 3 months, 6 months, 12 months, and 18 months)
- App Feasibility and Usability using the Feasibility and Usability Survey(6 months, 12 months, and 18 months)
- Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale(Baseline, 12 months, and 18 months)
- Media Questionnaire(Up to 12 months)
- App Data(6 months, 12 months, and 18 months)
- PROMIS Social Isolation Short Form 4a(Up to 12 months)
- Stressful Life Events assessed by the Holmes and Rahe Stress Inventory(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI)(Baseline, 3 months, and 12 months)
- General Self Efficacy(Baseline, 12 months, and 18 months)
- MedGem(Baseline)
- CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form(Up to 12 months)
- Metabolic Score Calculator (MetS)(Baseline, 3, 6, 12, and 18 months)