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临床试验/NCT04309513
NCT04309513已完成不适用

Evaluation of the Personal Activity Intelligence (PAI) Score in a Corporate Wellness Setting.

Ohio University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年8月1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
入组人数
73
试验地点
1
主要终点
Physical Activity Level

研究概览

简要总结

This will be a prospective randomized controlled study to evaluate the effectiveness of the Personal Activity Intelligence (PAI) Score to encourage physical activity.

Participants will utilize a wearable wrist device that will provide data pertaining to physical activity, to include steps taken, miles walked, heart rate, calories burned, etc. The intervention group devices will also provide a visible PAI score and will be given information about a PAI app they can install on their smart phone to monitor their activity

Control participants will be encouraged to work up to at least 10,000 steps a day, higher if possible and reasonable.

Those with a device that displays a PAI score (study participants) will be encouraged to work up to and maintain the highest PAI score possible, with 100 being the ideal.

详细描述

The objective is to determine if utilizing the PAI score as a single measure for goal setting is superior to monitoring steps / distance, calories burned, and / or time in aerobic activity in achieving improvements in health.

Study participants will have enrolled in Corporate Wellness Program at Memorial health System (MHS), and have met the inclusion criteria and consented.

Participants will be randomly assigned to one of the groups. Members from the same household will be assigned to the same group together.

All devices will be linked, via smart phone, to a fitness tracker app that is imbedded in the MHS medical record, and has a patient access portal accessible to the patient via website or app on a smart phone or tablet.

The intervention device will also link to a smart phone app developed by PAI that displays PAI score to the participant as well as other data, to allow tracking.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult who is enrolled in the Memorial Health System (MHS) corporate wellness study.
  • •Is interested in increasing level of physical activity.
  • •Is able to walk at least a mile a day.
  • •Has a device that is compatible with the software (Apple watch, Fitbit, Garmin) or is willing to purchase a device for $25 offered as part of this study.

排除标准

  • •Does not speak English
  • •Has been told by a medical provider to not participate in physical activity.
  • •Is taking a beta blocker medication (which slows the heart rate) (https://www.medicinenet.com/beta_blockers/article.htm#list_of_examples_of_brand_and_generic_names_for_beta_blockers_available)
  • •Has a medical condition that prevents walking at least a mile a day.
  • •Has a pacemaker or defibrillator.
  • •Is currently in cardiac rehab
  • •Is not able to manage an app on a "smart phone".
  • •Deemed unsuitable to the program by Dr. Drozek or other members of the wellness team. (mental impairment, etc.)

研究组 & 干预措施

Step Counter to motivate physical activity

Active Comparator

Participants will be encouraged to work up to achieving at least 10,000 steps a day, higher if possible and reasonable, as measured by a wearable device.

干预措施: Step Counter to motivate physical activity (Behavioral)

PAI score to motivate physical activity

Experimental

Participants will be encouraged to work up to and maintain the highest PAI score possible, with 100 being the ideal, as measured by a wearable device.

干预措施: PAI score to motivate physical activity (Behavioral)

结局指标

主要结局

Physical Activity Level

时间窗: 2 years

Change in Exercise Vital Signs obtained by survey at 2 years. 1. Are you able to walk a mile without significant pain or discomfort? ❒ Yes ❒ No 2. In the past 7 days, how many days did you exercise? ______ days 3. On days when you exercised, for how long did you exercise (in minutes)? ❒______ minutes per day ❒ Does not apply 4. How intense was your typical exercise? * Light (like stretching or slow walking) * Moderate (like brisk walking) * Heavy (like jogging or swimming) * Very heavy (like fast running or stair climbing) * I am currently not exercising

次要结局

  • Glycosylated Hemoglobin (HbA1c)(2 years)
  • Blood pressure (systolic and diastolic)(2 years)
  • BMI(2 years)
  • Daily Step Count(2 years)
  • Total cholesterol(2 years)
  • Low Density Lipoprotein (LDL) cholesterol(2 years)
  • High Density Lipoprotein (HDL) cholesterol(2 years)
  • Mood(2 years)
  • Triglycerides(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Drozek

Associate Professor

Ohio University

研究点 (1)

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