NCT01550822已完成不适用
HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program
Los Amigos Research and Education Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise, and smoking cessation) among stroke survivors and result in a reduction in measures of general and abdominal obesity.
详细描述
Study data collection will consist of a baseline and outcome study visit. Each visit will consist of a survey and physical exam to collect height, weight and body measurements.
Outcome measures include:
- Physical Activity: Collected via survey using a version of the International Physical Activity Questionnaire
- Diet: Collected via survey using the Brief Dietary Assessment Tools for Hispanics
- Body Mass Index (BMI): Collected via physical exam following the Alaska State Department of Health and Social Services BMI Guidelines
- Abdominal Obesity: Collected via physical exam following the NIH Standard Circumference methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I: Completed 12 month SUSTAIN trial (SUSTAIN criteria: age ≥ 40 years, acute TIA or ischemic stroke within the prior one month and systolic blood pressure (SBP) >120 mm Hg).
- •Phase II: Stroke or TIA > 3 months prior to screening date, age > 20 years, blood pressure (SBP) > 120 mm Hg.
排除标准
- •Phase I and Phase II: Same as SUSTAIN criteria: medical condition limiting participation in follow up assessments, severe cognitive impairment (MMSE ≤24), and severe global disability (modified Rankin ≥3).
结局指标
主要结局
Physical activity
时间窗: 6 months
90 minutes/week moderate activity; change in minutes of physical activity/week
Diet
时间窗: 6 months
≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day
BMI
时间窗: 6 months
BMI 18.5-24.9 kg/m2; change in BMI
次要结局
- Abdominal obesity(6 months)
研究者
研究点 (2)
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