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临床试验/NCT03969056
NCT03969056终止不适用

Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Changes in weekly daily average steps

研究概览

简要总结

In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age ≥18 years
  • •systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood *pressure between 80 to 100 mmHg in a research office
  • •speaking and reading English
  • •being physically inactive at work or during leisure time and willing to be physically active
  • •having an iPhone 8 or newer or an Android Lollipop or newer

排除标准

  • •self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
  • •current participation in a lifestyle modification program or research study
  • •self-report of being currently pregnant.

研究组 & 干预措施

Artificial Intelligence (AI) Activity group

Experimental

Participants in this group receive an AI based intervention (automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning and message)

干预措施: Artificial Intelligence (AI) Activity (Behavioral)

Control group

Active Comparator

Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.

干预措施: 10,000 steps (Behavioral)

结局指标

主要结局

Changes in weekly daily average steps

时间窗: Baseline (run-in period), 4 week-test period, and 3-month intervention period

measured by ActiGraph GT9X Link\]

Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day

时间窗: Baseline (run-in period), 4 week-test period, and 3-month intervention period

measured by ActiGraph GT9X Link\]

次要结局

  • Changes in diastolic blood pressure (DBP)(Baseline (run-in period), 4 week-test period, and 3-month intervention period)
  • Changes in Systolic blood pressure (SBP)(Baseline (run-in period), 4 week-test period, and 3-month intervention period)
  • Changes in weight(Baseline (run-in period), 4 week-test period, and 3-month intervention period)
  • Changes in Body Mass Index (BMI)(Baseline (run-in period), 4 week-test period, and 3-month intervention period)
  • aortic stiffness(Baseline (run-in period), 4 week-test period, and 3-month intervention period)
  • sodium intake(Baseline (run-in period), 4 week-test period, and 3-month intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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