Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2018-10-02
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ohio University
OTHER
Responsible Party
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David Drozek
Associate Professor
Principal Investigators
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David S Drozek, DO
Role: PRINCIPAL_INVESTIGATOR
Ohio University
Locations
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Ohio University
Athens, Ohio, United States
Countries
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Other Identifiers
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18-X-263
Identifier Type: -
Identifier Source: org_study_id
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