Providing Personalized Health and Individual Lifestyle Enhancing Solutions (Prophiles) in Cardiovascular Disease (CVD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
研究概览
简要总结
The objective of the proposed project is to evaluate the usability, acceptability, and adherence of a lifestyle and behavioral self-tracking and ePersuasive tool aimed at improving: 1) adherence to diet/nutrition (<1500 mg of sodium/day and less than 10% daily free sugar intake), physical activity (PA) (150 minutes of moderate PA/week), and sleep guidelines (7-8 hours of sleep/day)-- and 2) control 3% reduction in systolic BP and glucose from baseline to end of study follow-up after 2 months (exploratory objective) in a sample of 20 patients with Hypertension or Diabetes. The study will utilize a Step-Wedge Design where the 20 patients will be divided into 4 wedges (5 patients in each wedge).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NYU and/or Bellevue patient
- •Diagnosed with HTN and pre-diabetes/diabetes
- •Must be English speakers
- •Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants
- •Must be ambulatory
排除标准
- •are unable or unwilling to provide informed consent;
- •are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
- •are pregnant, are currently trying to become pregnant, or who become pregnant during the study
- •are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
- •have had or are planning to have bariatric surgery during the study
- •have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
结局指标
主要结局
Measure of physical activity by the International Physical Activity Questionnaire (IPAQ)
时间窗: 12 Months
Used to assess physical activity and calculate metabolic equivalent
User Acceptance measured by adherence to diet and nutrition using the Healthy Eating Survey
时间窗: 12 Months
次要结局
未报告次要终点