Pre-hypertension
Conditions
Brief summary
In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.
Interventions
BEHAVIORALAI-Based Lifestyle Recommendations
The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
OTHERNo Lifestyle Recommendations
The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age ≥18 years * SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office * speaking and reading English * having an iPhone 8 or newer or an Android x or newer
Exclusion criteria
* currently taking antihypertensive medication * 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 |
|---|---|---|
| Average change in systolic blood pressure (SBP) in experimental vs. control group | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total | Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient. |
| Average change in diastolic blood pressure (DBP) in experimental vs. control group | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total | Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients in experimental group that followed lifestyle recommendations | Initial 2 week data collection, weekly lifestyle recommendations, 6 months total | This secondary outcome measure is interested in assessing patient engagement within the experimental group. Data from the activity tracker (steps, sleep quality, active minutes, etc.) will be used to assess whether a patient followed the lifestyle recommendations. |
Countries
United States
Contacts
Primary ContactSujit Dey, PhD
Outcome results
None listed