Personal Activity Intelligence (PAI) Pilot

Not Applicable

Completed

• Conditions: Overweight and Obesity; Diabetes; Dyslipidemias; Cardiovascular Diseases; Hypertension
• Interventions: Behavioral: PAI

• Registration Number: NCT03740074
• Lead Sponsor: Ohio University

Brief Summary

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

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 Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAI	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.

Primary Outcome Measures

Name	Time	Method
App utility	12 weeks	ease in use of obtaining and using PAI score by the patient based on a patient survey

Secondary Outcome Measures

Name	Time	Method
Weight	12 weeks	change in weight
Systolic blood pressure	12 weeks	change in systolic blood pressure
Diastolic blood pressure	12 weeks	change in diastolic blood pressure
Personal Activity Intelligence (PAI) Score	12 weeks	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.

Trial Locations

Locations (1)

Ohio University; 🇺🇸 Athens, Ohio, United States