Personal Activity Intelligence (PAI) Pilot (PAI)

Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study

Pilot study to evaluate the use of the Personal Activity Intelligence (PAI) score in a clinical setting.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes; Dyslipidemias; Overweight and Obesity
• Intervention / Treatment: Behavioral: PAI

Detailed Description

This is a pilot project to evaluate the feasibility of a larger study to evaluate the effectiveness of Personal Activity Intelligence (PAI) score in patients with chronic disease, as an adjunct to lifestyle medical therapy.

The PAI score is a proprietary formula developed by PAI Health (PH) to aid physical fitness. A PAI score calculation uses biometrics obtained via a device that measures heart rate and steps. For this study, Mio Slice, a commercial wrist worn device will be utilized to obtain data which will be linked to a smart phone. Data from the smart phone app will be accessed by PAI Health. Feedback information will be given to the participants to encourage increased physical activity.

The short-term aim of this study is to evaluate the logistics of utilizing PAI in the patient setting.

The data obtained from this study will be utilized to devise a larger study to evaluate the utility of PAI in patients with chronic disease who are receiving lifestyle medical therapy.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
• Participants must own a smart phone and feel comfortable managing apps on their smart phone.
• Participants must be willing and able to register online with PAI Health (PH)
• Participants must be willing to wear a wrist device around the clock, except when charging or bathing for 12 weeks.
• Participants must have at least one of the following diagnoses:
• overweight / obesity
• diabetes or prediabetes
• hypertension or pre-hypertension
• abnormal lipids
• cardiovascular disease

Exclusion Criteria:

• Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PAI; Participants will utilize a MIO Slice wearable device to generate a PAI score, which will be utilized to provide feedback and incentive for physical activity.

Behavioral: PAI; Consenting subjects will be given a Mio Slice, along with instructions on how to utilize the device. They will register on line with PAI Health, and will be asked to sync their device at least once every 7 days. They will be encouraged to look at the device app on their smart phone at least once daily. After 1 week of obtaining baseline data, subjects will be encouraged to try to obtain a PAI score of at least 30 initially. Once they obtain a score of 30 consistently, they will be encouraged to increase the score toward 50. If they consistently obtain 50, they can increase their goal sequentially toward a maximum goal of 100. The duration of the study will be 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App utility	ease in use of obtaining and using PAI score by the patient based on a patient survey	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	change in systolic blood pressure	12 weeks
Diastolic blood pressure	change in diastolic blood pressure	12 weeks
Weight	change in weight	12 weeks
Personal Activity Intelligence (PAI) Score	The Personal Activity Intelligence (PAI) Score is a proprietary calculation owned by PAI Health, and not made available to the investigator. The score does take in to account resting heart rate while sleeping, peak heart rate during physical activity, length of time of elevated heart rate, steps. This data is captured via a wearable device, Mio Slice which is synced with a smart phone. Participants are encouraged to keep their PAI Score at 100, or as high as possible.	12 weeks

Collaborators and Investigators

• Sponsor: Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Body Weight; Lipid Metabolism Disorders; Cardiovascular Diseases; Dyslipidemias; Overweight
• Other Study ID Numbers: 18-X-263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No