AI Activity Study in Patients With Elevated Blood Pressure

Study Overview
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Brief Summary
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In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.

Official Title
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Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Artificial Intelligence (AI) Activity
* Behavioral: 10,000 steps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood *pressure between 80 to 100 mmHg in a research office speaking and reading English being physically inactive at work or during leisure time and willing to be physically active having an iPhone 8 or newer or an Android Lollipop or newer Exclusion Criteria: self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes) current participation in a lifestyle modification program or research study self-report of being currently pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Intelligence (AI) Activity group<br>Participants in this group receive an AI based intervention (automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning and message) | Behavioral: Artificial Intelligence (AI) Activity<br>* The intervention provides participants with an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning.<br>|
| Active Comparator: Control group<br>Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention. | Behavioral: 10,000 steps<br>* The intervention provides participants with an automated daily 10,000 step goal intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weekly daily average steps | measured by ActiGraph GT9X Link] | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day | measured by ActiGraph GT9X Link] | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Systolic blood pressure (SBP) |  | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| Changes in diastolic blood pressure (DBP) |  | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| aortic stiffness | measured by SphigmoCor XCEL system | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| sodium intake | as measured in 24-hour urine samples | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| Changes in weight |  | Baseline (run-in period), 4 week-test period, and 3-month intervention period | 
| Changes in Body Mass Index (BMI) | using weight and height to calculate | Baseline (run-in period), 4 week-test period, and 3-month intervention period |