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A Wearable mHealth Device to Promote Teenagers' Physical Activity

2016年4月12日 更新者:Jason Mendoza、Seattle Children's Hospital

A Wearable mHealth Device to Promote Teenagers' Physical Activity: A Pilot RCT

Due to disparities in childhood obesity, interventions for physical activity promotion and obesity prevention for low socioeconomic and racial/ethnic minority children and adolescents are vital to address disparities across the lifespan. Mobile health applications (mHealth apps) are a rapidly growing and promising approach for interactive and individualized interventions for disease prevention. Smart phones are a promising platform to reach racial/ethnic minority and lower income groups due to high rates of adoption of smart phone usage among these groups When paired with wearable sensing devices, mHealth apps for smart phones can collect data and provide feedback to users in real time. In a study among university students regarding mHealth apps, participants expressed interest in the "ability to record and track behaviors and goals and the ability to acquire advice and information 'on the go'". For physical activity in particular, wearable physical activity monitors designed for consumers that objectively measure and display data related to an individual's physical activity on smart phones through mHealth apps have become widely available and affordable. These wearable devices wirelessly upload data and provide users with physical activity data visualization and goal setting features that can be customized for each user via internet-based applications for smart phones, tablets, and/or computers. While several internet-based behavioral programs to promote pediatric physical activity have been reported in a recent review, none examined wearable sensing devices coupled with mHealth apps. Similarly, a 2013 review on mHealth technologies for physical activity assessment and promotion reported no studies that used wearable sensing devices for intervention delivery and called for research to evaluate feasibility.

The Primary Goal is to conduct a pilot randomized controlled trial (RCT) of the FitBit Flex, a popular wearable physical activity sensing device that allows data visualization and goal setting on smart phones. The target population will be adolescents ages 14-18 years old in the Seattle-metro area (n=40) with approximately 50% from low income households or belonging to a racial/ethnic minority. We will target this older age group since they have the lowest levels of physical activity among the pediatric population. This pilot study will provide feasibility and preliminary data for a future R01-funded RCT of the Flex mHealth device and app.

研究概览

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98145-5005
        • Seattle Children's Research Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 14-18 years old
  • lives in the Seattle-metro area
  • able to complete forms in English
  • no restrictions by a health care provider on physical activity or walking
  • own a smart phone or similar FitBit compatible mobile device (e.g. iPod Touch)
  • agree to install and share data from the FitBit Flex smart phone app with the investigators
  • attends study high school or health clinic or receives and clicks on a Facebook advertisement for the study

Exclusion Criteria:

  • has been restricted by a health care provider for physical activity or walking
  • does not live in the Seattle-metro area
  • does not attend a study school or clinic, or did not receive a Facebook advertisement for the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:等候名单控制
不干预
实验性的:FitBit only
Participants will use the FitBit device
Participants will use the FitBit device
实验性的:FitBit and Text Messages
Participants will use the FitBit device and receive daily affective text messages
Participants will use the FitBit device and receive daily affective text messages

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Post-intervention daily steps
大体时间:Measured during weeks 3-4 of the intervention
Measured during weeks 3-4 of the intervention

次要结果测量

结果测量
措施说明
大体时间
Pre-intervention daily steps
大体时间:Baseline
Baseline
Pre-intervention moderate-to-vigorous physical activity (MVPA)
大体时间:Baseline
Accelerometry
Baseline
Post-intervention moderate-to-vigorous physical activity
大体时间:During weeks 3-4 of the intervention
accelerometry
During weeks 3-4 of the intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jason A Mendoza, MD, MPH、University of Washington
  • 首席研究员:Megan Moreno, MD, MPH、University of Washington

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年3月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年1月7日

首先提交符合 QC 标准的

2014年1月7日

首次发布 (估计)

2014年1月9日

研究记录更新

最后更新发布 (估计)

2016年4月13日

上次提交的符合 QC 标准的更新

2016年4月12日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • SCRI-24100018

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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