Clinical trial NCT03969056: AI Activity Study in Patients With Elevated Blood Pressure
Official title: Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in weekly daily average steps
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary outcomes:
measure: Changes in Systolic blood pressure (SBP)
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: Changes in diastolic blood pressure (DBP)
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: aortic stiffness
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: sodium intake
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: Changes in weight
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
measure: Changes in Body Mass Index (BMI)
timeFrame: Baseline (run-in period), 4 week-test period, and 3-month intervention period
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yoshimi Fukuoka, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References: