Hypertension
Conditions
Brief summary
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.
Interventions
BEHAVIORALArtificial Intelligence (AI) Activity
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.
BEHAVIORAL10,000 steps
The intervention provides participants with an automated daily 10,000 step goal intervention
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in weekly daily average steps | Baseline (run-in period), 4 week-test period, and 3-month intervention period | measured by ActiGraph GT9X Link\] |
| Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day | Baseline (run-in period), 4 week-test period, and 3-month intervention period | measured by ActiGraph GT9X Link\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| aortic stiffness | Baseline (run-in period), 4 week-test period, and 3-month intervention period | measured by SphigmoCor XCEL system |
| sodium intake | Baseline (run-in period), 4 week-test period, and 3-month intervention period | as measured in 24-hour urine samples |
| Changes in Systolic blood pressure (SBP) | Baseline (run-in period), 4 week-test period, and 3-month intervention period | — |
| Changes in Body Mass Index (BMI) | Baseline (run-in period), 4 week-test period, and 3-month intervention period | using weight and height to calculate |
| Changes in weight | 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 | — |
Countries
United States
Outcome results
None listed