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Completed

NCT Number: NCT03740074

Personal Activity Intelligence (PAI) Pilot

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

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Key information

Conditions

Overweight and Obesity Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAI

Behavioral

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 outcomes

  1. App utility

    Time frame: 12 weeks

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

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 12 weeks

    change in systolic blood pressure

  2. Diastolic blood pressure

    Time frame: 12 weeks

    change in diastolic blood pressure

  3. Weight

    Time frame: 12 weeks

    change in weight

  4. Personal Activity Intelligence (PAI) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Official study title

Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study

Acronym: PAI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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