NCT03969056

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

May 20, 2019

Last Update Submit

December 14, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

    Baseline (run-in period), 4 week-test period, and 3-month intervention period

  • sodium intake

    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

  • +1 more secondary outcomes

Study Arms (2)

Artificial Intelligence (AI) Activity group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Behavioral: 10,000 steps

Interventions

Artificial Intelligence (AI) ActivityBEHAVIORAL

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.

Artificial Intelligence (AI) Activity group
10,000 stepsBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Artificial IntelligenceExercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical ConceptsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yoshimi Fukuoka, PhD, RN, FAAN

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 31, 2019

Study Start

February 6, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)