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Clinical Trials/NCT04309513
NCT04309513CompletedNot Applicable

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

Ohio University1 site in 1 country73 target enrollmentStarted: August 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
73
Locations
1
Primary Endpoint
Physical Activity Level

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.)

Arms & Interventions

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.

Intervention: 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.

Intervention: PAI score to motivate physical activity (Behavioral)

Outcomes

Primary Outcomes

Physical Activity Level

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Drozek

Associate Professor

Ohio University

Study Sites (1)

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