AI Activity Study in Patients With Elevated Blood Pressure

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03969056
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Artificial Intelligence (AI) Activity; Behavioral: 10,000 steps	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Applying Artificial Intelligence to a Physical Activity Intervention in Patients With Elevated Blood Pressure- a Pilot Randomized Controlled Trial
• Actual Study Start Date: Feb 6, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in weekly daily average steps [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

   measured by ActiGraph GT9X Link]

2. 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 Outcome Measures

1. Changes in Systolic blood pressure (SBP) [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

2. Changes in diastolic blood pressure (DBP) [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

3. aortic stiffness [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

   measured by SphigmoCor XCEL system

4. sodium intake [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

   as measured in 24-hour urine samples

5. Changes in weight [Baseline (run-in period), 4 week-test period, and 3-month intervention period]

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94118

Sponsors and Collaborators

• University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03969056
• Other Study ID Numbers: 18-26452
• First Posted: May 31, 2019
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Mar 22, 2021