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临床试验/NCT03937674
NCT03937674已完成不适用

Heart Steps: Adaptive mHealth Intervention for Physical-Activity Maintenance

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
2
主要终点
30 minute step count

研究概览

简要总结

The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults.

详细描述

This project file refers to Aim 2 and Aim 3 of the National Heart, Lung, and Blood Institute (NHLBI) grant. Aim 1 is registered in clinical trials.gov under a separate project file number, NCT03225521.

Many of the risk factors for heart disease are behavioral, such as physical inactivity, smoking, and diets high in saturated and trans-fats. Prevention programs are effective at helping patients make the initial lifestyle changes needed to reduce their risks, but patients often struggle to maintain those changes.

In this study the investigators propose to develop a novel mHealth application for supporting maintenance of physical activity. Kaiser Permanente Washington Health Research Institute (KPWHRI) will conduct a prospective study to test the application among Kaiser Permanente Washington (KPW) men and women with blood pressure that falls in the stage 1 hypertension range. By taking advantage of the frequent interactions that individuals have with their mobile phones throughout the day, the investigators will design and evaluate an adaptive, personalized application that (1) keeps patients reminded of their health goals and motivations; (2) provides actionable ideas for how patients can be active right now, given their current context; and (3) helps patients plan and reflect on their physical activity to enable creation of robust and sustainable physical-activity habits. In addition, the application will adapt its functioning for each patient over time in order to minimize user burden while optimizing its ability to encourage physical activity and maintain engagement with the intervention.

Through three Specific Aims-intervention development, intervention optimization, and pilot evaluation-this project will contribute: (1) understanding of how burden and intervention engagement change over time and how they are influenced by intervention delivery and patients' behavior and context; (2) generalization of learning algorithms that are used to personalize web content based on users' characteristics and past behavior for use in mHealth interventions for behavioral maintenance; and (3) new insights about how reflective and automated self-regulatory processes interact over time to support behavioral maintenance and how to optimally recruit these processes through an mHealth intervention.

Aim 2: Optimize intervention and investigate influences on participant response.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • Recent blood pressure readings that falls in the stage 1 hypertension range by new AHA/ACC guidelines [>= 130 systolic]
  • Owns an iPhone
  • Able to walk for 10 minutes without pain
  • Expresses desire during study screen to increase physical activity

排除标准

  • Taking hypertension meds
  • Any diagnosis where physical activity would be counterindicated
  • Recent acute cardio vascular event
  • Major psychiatric illness

结局指标

主要结局

30 minute step count

时间窗: 30 minutes

step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.

Daily step count

时间窗: 24 hours

Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.

次要结局

  • MVPA(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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