Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AI Activity Study in Patients With Elevated Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969056
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 6, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in weekly daily average steps [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
  2. Changes in diastolic blood pressure (DBP) [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
  3. aortic stiffness [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
    measured by SphigmoCor XCEL system

  4. sodium intake [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
    as measured in 24-hour urine samples

  5. Changes in weight [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
  6. Changes in Body Mass Index (BMI) [ Time Frame: Baseline (run-in period), 4 week-test period, and 3-month intervention period ]
    using weight and height to calculate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969056


Contacts
Layout table for location contacts
Contact: Yoshimi Fukuoka, PhD, RN, FAAN 415-476-8419 AIActivity.Study@ucsf.edu
Contact: Kiley Charbonneau 415-514-0962 AIActivity.Study@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Yoshimi Fukuoka, PhD, RN, FAAN University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03969056    
Other Study ID Numbers: 18-26452
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases