Efficacy of an Evidence-based Healthy Lifestyle Intervention for People Following CVA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 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 the Group Lifestyle Balance (GLB) program adapted for people with stroke (CVA) on primary (weight) and secondary outcomes at 3, 6, 12 months from enrollment into the program.
详细描述
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.
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)
盲法说明
Outcomes Assessor will be masked to group allocation.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years of age
- •All types of stroke
- •At least 12 months post first stroke
- •Physician approval
排除标准
- •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
结局指标
主要结局
Change in weight
时间窗: Baseline, 3, 6, 12 months
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
- Neighborhood walkability using Walk Score®(Baseline)
- Biomarker Analysis(Baseline, 3, and 6 months)
- Cholesterol(Baseline, 3, 6, 12 months)
- Perceived Social Support(Baseline and 12 months)
- Stressful Life Events using the Holmes and Rahe Stress Inventory(Baseline and 12 months)
- Habit Formation(Baseline, 3, and 12 months)
- Physical Activity(Baseline, 3, 6, 12 months)
- Risk of Diabetes(Baseline, 3, 6, 12 months)
- 10 Meter Walk Test (10MWT)(Baseline, 3, 6, 12 months)
- Self-reported activities of health using the Self-Rated Abilities for Health Practice scale(Baseline and 12 months)
- Arm Circumference(Baseline, 3, 6, 12 months)
- 6 Minute Walk Test (6MWT)(Baseline, 3, 6, 12 months)
- Behavioral Risk Factor Surveillance(Baseline, 3, 6, 12 months)
- HbA1c(Baseline, 3, 6, and 12 months)
- Blood Pressure(Baseline, 3, 6, 12 months)
- Stroke Severity(Baseline)
- Resting Metabolic Rate(Baseline)
- Pain Interference(Baseline, 3, 6, and 12 months)
- CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form(Up to 12 months)
- Participant quality of ife(Baseline, 6, 12 months)
- Executive Function and Cognition using the Montreal Cognitive Assessment(Baseline, 3, and 12 months)
- Waist Circumference(Baseline, 3, 6, and 12 months)
- Blood Glucose(Baseline, 3, 6, 12 months)
- PROMIS Social Isolation Short Form 4a(Up to 12 months)
- Media Questionnaire(Up to 12 months)
- Sleep Disturbance(Baseline, 3, 6, 12 months)
- Triglycerides(Baseline, 3, 6, 12 months)
- Stages of Change(Baseline, 3, 6, and 12 months)
- Metabolic Score Calculator (MetS)(Baseline, 3, 6, and 12 months)