AI Activity Study in Patients With Elevated Blood Pressure

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Artificial Intelligence (AI) Activity; Behavioral: 10,000 steps

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artificial Intelligence (AI) Activity group; 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; 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.
Active Comparator: Control group; Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.	Behavioral: 10,000 steps; The intervention provides participants with an automated daily 10,000 step goal intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Yoshimi Fukuoka, PhD, RN, FAAN, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 18-26452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No