Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site
详细描述
Despite strong efficacy data, CDC recognition of our modified curricula, and online training modules, efforts to ensure the systematic adoption of our GLB-TBI evidence based intervention (EBI) in real-world settings (i.e., CDC-recognized sites) remain limited, yet are critically needed. The proposed scale-up evaluation trial is an important and logical next step in this systematic line of research to increase the impact and scope of our GLB-TBI EBI. The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI EBI in a real world setting at a CDC-recognized site. Results will provide a scalable EBI that can be implemented at CDC-recognized sites nationally) to improve obesity and cardiometabolic health of people with TBI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥6 months post-TBI
- •Moderate to severe TBI at time of injury
- •BMI ≥25 kg/m2
- •Able to communicate in English
排除标准
- •Contraindications to physical activity
- •Low cognitive function
- •Residing in hospital, acute rehab, SNF
- •Self-Reported Pregnancy
- •Pre-existing diagnosis of an eating disorder
- •Former DPP-GLB Participants (less than 6months since participation ended)
研究组 & 干预措施
Cohort 1
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 2
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 3
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 4
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 5
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 6
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 7
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 8
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
Cohort 9
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
Cohorts consist of 8-10 people.
干预措施: Group Lifestyle Balance for People with TBI (GLB-TBI) (Behavioral)
结局指标
主要结局
Body Weight
时间窗: Baseline and 12 months
Body weight will be measured at each session using an accessible scale.
次要结局
- Lipid Panel(Baseline and 12 months)
- Blood Pressure(Baseline and 12 months)
- Hemoglobin A1c(Baseline and 12 months)
- Fasting Blood Glucose(Baseline and 12 months)
- Self-Efficacy(Baseline and 12 months)
- Exit Survey(12 months)