Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA)
关键词
抽象
描述
Weight gain greatly increases the risk of chronic diseases after stroke 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 CVA. 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 after CVA. Investigators modified the program to meet the needs of people post stroke (GLB-CVA).
Study Aims:
The study consists of five specific aims.
Specific Aim 1: To create an appropriate adaptation of the DPP-GLB program that meets the unique needs of people post CVA (GLB-CVA) using a Community-Based Participatory Research approach and Advisory Board of key stakeholders (patients, caregivers, clinicians, researchers).
Specific Aim 2: To establish the feasibility of delivering the GLB-CVA intervention.
Specific Aim 3: Conduct a randomized controlled trial (RCT) to examine the effectiveness of the GLB-CVA on primary and secondary outcomes in the intervention group compared to the wait-list control group at 3, 6, and 12 months from baseline.
Specific Aim 4: Describe the effect of the GLB-CVA on metabolic biomarkers in the experimental group compared to the wait-list control group at baseline, 3, and 6 months.
Specific Aim 5: Describe the association between biomarkers of neurodegeneration and physiologic, functional, and patient reported outcomes at baseline, 3, and 6 months.
日期
最后验证: | 03/31/2020 |
首次提交: | 03/06/2019 |
提交的预估入学人数: | 03/11/2019 |
首次发布: | 03/12/2019 |
上次提交的更新: | 04/14/2020 |
最近更新发布: | 04/16/2020 |
实际学习开始日期: | 07/07/2019 |
预计主要完成日期: | 06/29/2021 |
预计完成日期: | 09/29/2021 |
状况或疾病
干预/治疗
Behavioral: GLB Weight-Loss Intervention
Other: Wait-List Control
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: GLB Weight-Loss Intervention The GLB program, adapted for individuals with stroke, will be delivered to participants over a 12-month period, divided into 22 in-person or virtual, group sessions. The intervention promotes 5-7% weight-loss by reducing calories and increasing exercise (150 minutes of moderate physical activity per week). | Behavioral: GLB Weight-Loss Intervention 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 is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting, and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems. The GLB curriculum used in this study has been adapted for people with stroke. |
Other: Wait-List Control The wait-list control group will receive no intervention for 6 months after enrollment. After the 6 month control period, the wait-list control group will receive the GLB Intervention. | Other: Wait-List Control Participants randomized to the wait-list control group will receive usual care for 6 months before beginning the modified GLB program. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 18 to 85 years of age - BMI ≥25 - All types of stroke - At least 12 months post first stroke - Physician approval Exclusion Criteria: - Low cognition - Not fluent in the English language - Conditions for which physical activity is contraindicated - Taking medication for type 2 diabetes - Residing in a hospital, acute rehabilitation setting, or skilled nursing facility - Pregnancy - Pre-existing diagnosis of an eating disorder |
结果
主要结果指标
1. Change in weight [Baseline, 3, 6, 12 months]
次要成果指标
1. Physical Activity [Baseline, 3, 6, 12 months]
2. Arm Circumference [Baseline, 3, 6, 12 months]
3. Blood Pressure [Baseline, 3, 6, 12 months]
4. Cholesterol [Baseline, 3, 6, 12 months]
5. Risk of Diabetes [Baseline, 3, 6, 12 months]
6. 10 Meter Walk Test (10MWT) [Baseline, 3, 6, 12 months]
7. 6 Minute Walk Test (6MWT) [Baseline, 3, 6, 12 months]
8. Perceived Social Support [Baseline and 12 months]
9. Self-reported activities of health using the Self-Rated Abilities for Health Practice scale [Baseline and 12 months]
10. Neighborhood walkability using Walk Score® [Baseline]
11. Resting Metabolic Rate [Baseline]
12. Behavioral Risk Factor Surveillance [Baseline, 3, 6, 12 months]
13. Participant quality of ife [Baseline, 6, 12 months]
14. Stressful Life Events using the Holmes and Rahe Stress Inventory [Baseline and 12 months]
15. Executive Function and Cognition using the Montreal Cognitive Assessment [Baseline, 3, and 12 months]
16. Habit Formation [Baseline, 3, and 12 months]
17. Stroke Severity [Baseline]
18. Pain Interference [Baseline, 3, 6, and 12 months]
19. Sleep Disturbance [Baseline, 3, 6, 12 months]
20. Waist Circumference [Baseline, 3, 6, and 12 months]
21. HbA1c [Baseline, 3, 6, and 12 months]
22. Triglycerides [Baseline, 3, 6, 12 months]
23. Blood Glucose [Baseline, 3, 6, 12 months]
24. Biomarker Analysis [Baseline, 3, and 6 months]
25. Stages of Change [Baseline, 3, 6, and 12 months]
26. Metabolic Score Calculator (MetS) [Baseline, 3, 6, and 12 months]