Personal Activity Intelligence (PAI) Pilot

NCT03740074 | Completed

• 1 other identifier: 18-X-263
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity; Diabetes; Hypertension; Dyslipidemias; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• App utility

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

  12 weeks

Secondary Outcomes (4)

• Systolic blood pressure

  12 weeks

• Diastolic blood pressure

  12 weeks

• Weight

  12 weeks

• Personal Activity Intelligence (PAI) Score

  12 weeks

Study Arms (1)

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.

Behavioral: PAI

Interventions

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.

PAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus; Hypertension; Dyslipidemias; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders

Study Officials

• David S Drozek, DO

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective pilot

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 14, 2018
• Study Start: October 2, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)