Evaluation of the Personal Activity Intelligence (PAI) Score

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309513
• Other study ID #: 20-X-88
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Participants will be asked to wear their devices on at least two nights during the first week, and daily while awake, except when bathing for the next 12 weeks.

Participants, having enrolled in the wellness program, will already, as a part of that study, have agreed to have data collected at baseline and yearly thereafter, including BMI, blood pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey, absenteeism and health claims data at baseline and yearly thereafter. If not collected within 60 days, a new set of data will be collected to serve as baseline for this study. Specifically for this study this data collection (including lab analysis) will also be repeated at 12 weeks and 6 months. All blood draws will be done at any MHS lab, by qualified phlebotomists, according to standard hospital policy.

The control group will be asked to work toward a goal of at least 10,000 steps a day, which can be seen on their device, as well as on the accompanying app.

The intervention group will be encouraged to work up to and maintain the highest PAI score possible, with at least 100 being the ideal. PAI will provide weekly summary data on participants that will allow additional evaluation correlating level of physical activity / PAI score with participant results. This data will be reported with a participant code. PAI will provide a master code linking the participant code to an email address for correlation of all data for analysis. This master code will be maintained on an encrypted device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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_g eneric_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.)

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• PAI score to motivate physical activity
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.
• Step Counter to motivate physical activity
Step Counter to motivate physical activity

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	Memorial Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level	Change in Exercise Vital Signs obtained by survey at 2 years.; Are you able to walk a mile without significant pain or discomfort? ? Yes ? No; In the past 7 days, how many days did you exercise? ______ days; On days when you exercised, for how long did you exercise (in minutes)?; ?______ minutes per day; ? Does not apply; 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	Daily Step Count	Change in number of steps per day achieved at 2 years	2 years
Secondary	BMI	Change in body mass index at 2 years, calculated by measuring height in feet / inches and weight in pounds.	2 years
Secondary	Glycosylated Hemoglobin (HbA1c)	Change in % of HbA1c from baseline at 2 years.	2 years
Secondary	Total cholesterol	Change in mg/dl from baseline at 2 years.	2 years
Secondary	Low Density Lipoprotein (LDL) cholesterol	Change in mg/dl from baseline at 2 years.	2 years
Secondary	High Density Lipoprotein (HDL) cholesterol	Change in mg/dl from baseline at 2 years.	2 years
Secondary	Triglycerides	Change in mg/dl from baseline at 2 years.	2 years
Secondary	Blood pressure (systolic and diastolic)	Change in blood pressure in mm Hg from baseline at 2 years.	2 years
Secondary	Mood	Change From baseline in mood scores on the The Patient Health Questionnaire-4 (PHQ-4) at 2 years, Higher score is more abnormal	2 years

External Links

•   Personal Activity Intelligence and Mortality in Patients with Cardiovascular Disease: The HUNT Study