Evaluation of the Personal Activity Intelligence (PAI) Score

NCT04309513 | Completed

• 1 other identifier: 20-X-88
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level

  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

  2 years

Secondary Outcomes (9)

• Daily Step Count

  2 years

• BMI

  2 years

• Glycosylated Hemoglobin (HbA1c)

  2 years

• Total cholesterol

  2 years

• Low Density Lipoprotein (LDL) cholesterol

  2 years

Study Arms (2)

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.

Behavioral: Step Counter to motivate physical activity

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.

Behavioral: PAI score to motivate physical activity

Interventions

PAI score to motivate physical activity BEHAVIORAL

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. Their devices and an accompanying app will provide them with an ongoing real time calculation of the PAI score.

PAI score to motivate physical activity

Step Counter to motivate physical activity BEHAVIORAL

Step Counter to motivate physical activity

Step Counter to motivate physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ohio University: lead
• Memorial Health System: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized control

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: August 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

US (1)