Ohio University
Athens, Ohio, 45701, United States
NCT Number: NCT04309513
This will be a prospective randomized controlled study to evaluate the effectiveness of the Personal Activity Intelligence (PAI) Score to encourage physical activity.
Participants will utilize a wearable wrist device that will provide data pertaining to physical activity, to include steps taken, miles walked, heart rate, calories burned, etc. The intervention group devices will also provide a visible PAI score and will be given information about a PAI app they can install on their smart phone to monitor their activity
Control participants will be encouraged to work up to at least 10,000 steps a day, higher if possible and reasonable.
Those with a device that displays a PAI score (study participants) will be encouraged to work up to and maintain the highest PAI score possible, with 100 being the ideal.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Athens, Ohio, 45701, United States
The objective is to determine if utilizing the PAI score as a single measure for goal setting is superior to monitoring steps / distance, calories burned, and / or time in aerobic activity in achieving improvements in health.
Study participants will have enrolled in Corporate Wellness Program at Memorial health System (MHS), and have met the inclusion criteria and consented.
Participants will be randomly assigned to one of the groups. Members from the same household will be assigned to the same group together.
All devices will be linked, via smart phone, to a fitness tracker app that is imbedded in the MHS medical record, and has a patient access portal accessible to the patient via website or app on a smart phone or tablet.
The intervention device will also link to a smart phone app developed by PAI that displays PAI score to the participant as well as other data, to allow tracking.
Participants will be asked to wear their devices on at least two nights during the first week, and daily while awake, except when bathing for the next 12 weeks.
Participants, having enrolled in the wellness program, will already, as a part of that study, have agreed to have data collected at baseline and yearly thereafter, including BMI, blood pressure, resting pulse, lipid panel, hemoglobin A1c, health risk assessment survey, absenteeism and health claims data at baseline and yearly thereafter. If not collected within 60 days, a new set of data will be collected to serve as baseline for this study. Specifically for this study this data collection (including lab analysis) will also be repeated at 12 weeks and 6 months. All blood draws will be done at any MHS lab, by qualified phlebotomists, according to standard hospital policy.
The control group will be asked to work toward a goal of at least 10,000 steps a day, which can be seen on their device, as well as on the accompanying app.
The intervention group will be encouraged to work up to and maintain the highest PAI score possible, with at least 100 being the ideal. PAI will provide weekly summary data on participants that will allow additional evaluation correlating level of physical activity / PAI score with participant results. This data will be reported with a participant code. PAI will provide a master code linking the participant code to an email address for correlation of all data for analysis. This master code will be maintained on an encrypted device.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be encouraged to work up to and maintain the highest PAI score possible, with 100 being the ideal, as measured by a wearable device. Their devices and an accompanying app will provide them with an ongoing real time calculation of the PAI score.
Step Counter to motivate physical activity
Time frame: 2 years
Change in Exercise Vital Signs obtained by survey at 2 years.
❒______ minutes per day
❒ Does not apply
Time frame: 2 years
Change in number of steps per day achieved at 2 years
Time frame: 2 years
Change in body mass index at 2 years, calculated by measuring height in feet / inches and weight in pounds.
Time frame: 2 years
Change in % of HbA1c from baseline at 2 years.
Time frame: 2 years
Change in mg/dl from baseline at 2 years.
Time frame: 2 years
Change in mg/dl from baseline at 2 years.
Time frame: 2 years
Change in mg/dl from baseline at 2 years.
Time frame: 2 years
Change in mg/dl from baseline at 2 years.
Time frame: 2 years
Change in blood pressure in mm Hg from baseline at 2 years.
Time frame: 2 years
Change From baseline in mood scores on the The Patient Health Questionnaire-4 (PHQ-4) at 2 years, Higher score is more abnormal
Ohio University
Other
Evaluation of the Personal Activity Intelligence (PAI) Score in a Corporate Wellness Setting.
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.
Published trials that share one or more normalized conditions with this study.
NCT07597460
Behavior, Child Health
Santiago, Chile
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729007
Behavior, Fitness
Madrid, Spain
View Trial DetailsNCT07723807
Behavior, Motor Activity
Jaén, Spain
View Trial Details