AI Activity Study in Patients With Elevated Blood Pressure

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Behavioral: 10,000 steps; Behavioral: Artificial Intelligence (AI) Activity

• Registration Number: NCT03969056
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-31
• Study Start: 2020-02-06
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	10,000 steps	Participants in this group receive a standardized and fixed 10,000 daily steps goal intervention.
Artificial Intelligence (AI) Activity group	Artificial Intelligence (AI) Activity	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)

Primary Outcome Measures

Name	Time	Method
Changes in weekly daily average steps	Baseline (run-in period), 4 week-test period, and 3-month intervention period	measured by ActiGraph GT9X Link\]
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

Name	Time	Method
Changes in diastolic blood pressure (DBP)	Baseline (run-in period), 4 week-test period, and 3-month intervention period
Changes in Systolic blood pressure (SBP)	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)	Baseline (run-in period), 4 week-test period, and 3-month intervention period	using weight and height to calculate
aortic stiffness	Baseline (run-in period), 4 week-test period, and 3-month intervention period	measured by SphigmoCor XCEL system
sodium intake	Baseline (run-in period), 4 week-test period, and 3-month intervention period	as measured in 24-hour urine samples

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States