Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample.
To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.
详细描述
Diabetes Prevention Program Group Lifestyle Balance Program (DPP-GLB): The DPP-GLB is a 12-month, evidence-based, CDC-accredited weight-loss intervention designed for delivery in group-based, community settings, and has resulted in weight loss in a variety of settings such as community centers, churches, worksites, and healthcare settings. Alternate modes of delivery (e.g., DVD, telehealth, telephone call) have also proven efficacious. The primary goal of the DPP-GLB intervention is to help the participant achieve and maintain a 5-7% weight loss by following federal guidelines for physical activity participation (safe and progressive increase to achieve 150 minutes of moderate intensity activity each week) and dietary recommendations.
DPP-GLB for individuals with TBI: In 2015 we modified the DPP-GLB with a group of stakeholders to meet the unique needs of individuals with TBI (GLB-TBI). We pilot tested the GLB-TBI in a group of 18 individuals with TBI who lost -10.2±13lbs (-5% weight-loss) over 12 months. These results warranted rigorous testing.
Efficacy of the GLB-TBI using an RCT: We then completed an in-person randomized controlled trial (RCT) to assess the efficacy of the GLB-TBI compared to an attention control (NCT03594734) for Dallas residents after TBI. Individuals in the GLB-TBI group (n=27) lost -17.8±41.4lbs (-7.9%) over the 12-month program and the attention control group (n=28) lost 0±55.4lbs (0%). The GLB-TBI group also had significant improvements in diastolic blood pressure, waist circumference, triglycerides, and HDL cholesterol. As a result of this strong evidence, our GLB-TBI curriculum was recognized by the CDC as an evidence-based approach to in-person weight-loss.
The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample.
To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •Greater than or equal to 6 months post traumatic brain injury (TBI)
- •Moderate to severe TBI at time of injury
- •Body Mass Index greater than or equal to 25
- •Able to participate in physical activity
- •Willing to use a tablet/computer/smartphone (either personal device or one provided by the research team)
排除标准
- •Contraindications to physical activity (e.g., uncontrolled hypertension, unstable angina, severe joint disease, uncontrolled vertigo/dizziness)
- •Not fluent in the English language
- •Low cognitive function
- •Residing in a hospital, acute rehabilitation facility, or skilled nursing facility
- •Diagnosed with or taking medications for Type 2 diabetes
- •Self-reported pregnancy
- •Pre-existing diagnosis of an eating disorder
结局指标
主要结局
Change in Weight
时间窗: Baseline, 3, 6, and 12 months
Weight will be obtained at a lab local to the participant based on their preference. Weight for participants randomized to the GLB-TBI will also be captured via self-weighing using provided BodyTrace Smart Scale, which include cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with in-person weighing in previous weight management research.Scales will be setup by our team before being mailed to participants with instructions for use.
次要结局
- Change in Lipid Panel(Baseline, 3, 6, and 12 months)
- Change in 8-Year Diabetes Risk(Baseline, 3, 6, and 12 months)
- Change in Dietary Change(Baseline, 3, 6, and 12 months)
- Change in Quality of Life After Brain Injury - Overall Scale(Baseline, 3, 6, and 12 months)
- Change in Exit Survey(12 months)
- Change in Waist Circumference(Baseline, 3, 6, and 12 months)
- Change in Neighborhood Environment Walkability Scale (NEWS)(Baseline, 3, 6, and 12 months)
- Change in Blood Pressure(Baseline, 3, 6, and 12 months)
- Change in Self-Rated Abilities for Health Practice (SRAHP)(Baseline, 3, 6, and 12 months)
- Change in Telehealth Usability Questionnaire (TUQ)(Baseline, 3, 6, and 12 months)
- Change in Hemoglobin A1c (HbA1c)(Baseline, 3, 6, and 12 months)
- Change in Arm Circumference(Baseline, 3, 6, and 12 months)
- Change in Metabolic Syndrome Severity Score(Baseline, 3, 6, and 12 months)
- Change in Healthy Eating and Physical Activity(Baseline, 3, 6, and 12 months)
研究者
Evan Elizabeth Rainey
Manager
Baylor Research Institute