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AI Activity Study in Patients With Elevated Blood Pressure

Primary Purpose

Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Artificial Intelligence (AI) Activity

10,000 steps

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial Intelligence (AI) Activity group

Control group

Arm Description

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)

Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.

Outcomes

Primary Outcome Measures

Changes in weekly daily average steps

measured by ActiGraph GT9X Link]

Duration (minutes) of moderate to vigorous intensity physical activity (MVPA) per day

measured by ActiGraph GT9X Link]

Secondary Outcome Measures

Changes in Systolic blood pressure (SBP)

Changes in diastolic blood pressure (DBP)

aortic stiffness

measured by SphigmoCor XCEL system

sodium intake

as measured in 24-hour urine samples

Changes in weight

Changes in Body Mass Index (BMI)

using weight and height to calculate

Full Information

NCT ID

NCT03969056

First Posted

May 20, 2019

Last Updated

March 17, 2021

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03969056

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 6, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Artificial Intelligence (AI) Activity group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.

Intervention Type

Behavioral

Intervention Name(s)

Artificial Intelligence (AI) Activity

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

10,000 steps

Intervention Description

The intervention provides participants with an automated daily 10,000 step goal intervention

Primary Outcome Measure Information:

Title

Changes in weekly daily average steps

Description

measured by ActiGraph GT9X Link]

Time Frame