AI Activity Study in Patients With Elevated Blood Pressure

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03969056
• Other study ID #: 18-26452
• Status: Terminated
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Artificial 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.
• 10,000 steps
The intervention provides participants with an automated daily 10,000 step goal intervention

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weekly daily average steps	measured by ActiGraph GT9X Link]	Baseline (run-in period), 4 week-test period, and 3-month intervention period
Primary	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	Changes in Systolic blood pressure (SBP)		Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary	Changes in diastolic blood pressure (DBP)		Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary	aortic stiffness	measured by SphigmoCor XCEL system	Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary	sodium intake	as measured in 24-hour urine samples	Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary	Changes in weight		Baseline (run-in period), 4 week-test period, and 3-month intervention period
Secondary	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