Overweight and ObesityPAINCT03740074
Personal Activity Intelligence (PAI) Pilot
A study testing PAI in people with Overweight and Obesity and Diabetes, run by Ohio University at 1 site in United States.
Trial summary
Pilot study to evaluate the use of the Personal Activity Intelligence (PAI) score in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Diabetes, Hypertension
- What is being tested?
- PAI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- diabetes or prediabetes
- hypertension or pre-hypertension
- abnormal lipids
- cardiovascular disease
Who cannot join
- Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- PAI
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Hypertension, Dyslipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PAI | Experimental | 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. Receives: Behavioral: PAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
App utility
ease in use of obtaining and using PAI score by the patient based on a patient survey
Measured: 12 weeks
Secondary outcomes (4)
Systolic blood pressure
change in systolic blood pressure
Measured: 12 weeks
Diastolic blood pressure
change in diastolic blood pressure
Measured: 12 weeks
Weight
change in weight
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start2 Oct 2018
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Drozek, Ohio University
- Investigators
- David S Drozek, DO, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740074
- Sponsor's protocol ID
- 18-X-263
- Acronym
- PAI
- Status last verified
- Sep 2020
- First submitted
- 8 Nov 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
- ClinicalTrials.gov ID
- NCT03740074
- Acronym / sponsor ID
- PAI / 18-X-263
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot
| Arm | Type | Receives |
|---|---|---|
| PAI | Experimental | Behavioral: PAIParticipants will utilize a MIO Slice wearable device to generate a PAI score, which will be utilized to provide feedback and incentive for physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAIConsenting 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. | Behavioural | PAI |
Primary outcome
App utility
Time frame: 12 weeks
ease in use of obtaining and using PAI score by the patient based on a patient survey
4 secondary outcomes
Systolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Personal Activity Intelligence (PAI) Score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Drozek, DO principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAI in people with Overweight and Obesity and Diabetes, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App utility (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.