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Personal Activity Intelligence (PAI) Pilot (PAI)

Primary Purpose

Overweight and Obesity, Diabetes, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAI
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PAI

Arm Description

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.

Outcomes

Primary Outcome Measures

App utility
ease in use of obtaining and using PAI score by the patient based on a patient survey

Secondary Outcome Measures

Systolic blood pressure
change in systolic blood pressure
Diastolic blood pressure
change in diastolic blood pressure
Weight
change in weight
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.

Full Information

First Posted
November 8, 2018
Last Updated
September 15, 2020
Sponsor
Ohio University
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1. Study Identification

Unique Protocol Identification Number
NCT03740074
Brief Title
Personal Activity Intelligence (PAI) Pilot
Acronym
PAI
Official Title
Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Diabetes, Hypertension, Dyslipidemias, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PAI
Intervention Description
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.
Primary Outcome Measure Information:
Title
App utility
Description
ease in use of obtaining and using PAI score by the patient based on a patient survey
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
change in systolic blood pressure
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
change in diastolic blood pressure
Time Frame
12 weeks
Title
Weight
Description
change in weight
Time Frame
12 weeks
Title
Personal Activity Intelligence (PAI) Score
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Drozek, DO
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

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Personal Activity Intelligence (PAI) Pilot

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