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临床试验/NCT03193229
NCT03193229已完成不适用

MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes

Philip Polgreen2 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
430
试验地点
2
主要终点
Total number of steps per day

研究概览

简要总结

The overarching objective of our work is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a text-messaging based intervention.

详细描述

This study will randomize participants to 2 groups, an intervention group that will receive a Fitbit and MapTrek, and a control group that will receive a Fitbit only. This study has 3 specific aims.

Aim 1- To determine if patients randomized to MapTrek walk more than the control patients.

Aim 2- To determine if patients randomized to MapTrek generally walk at a faster pace during the day than control patients.

Aim 3- To determine if patients randomized to MapTrek have less sedentary time during the day than the control patients.

We expect to collect sufficient data to demonstrate the effectiveness of MapTrek, our prototype m-health tool, as an intervention to increase physical activity, heighten intensity of activity, and reduce sedentary behavior among a cohort of patients at risk for type 2 diabetes.

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
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 21 years old
  • English speaker
  • Have a smart phone with texting and internet capabilities
  • No aversion to research studies
  • No active mental health conditions
  • Have a BMI > or equal to 25 and a history of hemoglobin A1C level between 5.7 and 6.4%, or 2) have a BMI > or equal to 30.

排除标准

  • Pregnancy
  • Prisoner status
  • Taking insulin or other diabetic medications

研究组 & 干预措施

MapTrek

Experimental

Patients in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). Each week, patients are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. MapTrek also supports Street View on Google Maps, so patients can explore what they would see if they were in that location. Throughout each race, patients will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.

干预措施: MapTrek (Behavioral)

MapTrek

Experimental

Patients in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). Each week, patients are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. MapTrek also supports Street View on Google Maps, so patients can explore what they would see if they were in that location. Throughout each race, patients will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.

干预措施: Fitbit (Device)

Fitbit Only

Active Comparator

Patients randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to MapTrek or simply by giving the patients a Fitbit.

干预措施: Fitbit (Device)

结局指标

主要结局

Total number of steps per day

时间窗: 6 months

The Fitbit will provide the total number of steps that each patient has taken per day.

次要结局

  • Pace of steps per day(6 months)

研究者

发起方
Philip Polgreen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philip Polgreen

Associate Professor of Medicine and Epidemiology; Director of Innovation Lab for Signal Center for Clinical Innovation

University of Iowa

研究点 (2)

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