NCT04543656

Brief Summary

In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

August 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

August 10, 2020

Last Update Submit

September 27, 2021

Conditions

Pre-hypertension

Outcome Measures

Primary Outcomes (2)

  • Average change in systolic blood pressure (SBP) in experimental vs. control group

    Average SBP during the first and last week of a patient's enrollment will be used to calculate SBP change for each patient.

    Initial 2 week data collection, weekly lifestyle recommendations, 6 months total

  • Average change in diastolic blood pressure (DBP) in experimental vs. control group

    Average DBP during the first and last week of a patient's enrollment will be used to calculate DBP change for each patient.

    Initial 2 week data collection, weekly lifestyle recommendations, 6 months total

Secondary Outcomes (1)

  • Number of patients in experimental group that followed lifestyle recommendations

    Initial 2 week data collection, weekly lifestyle recommendations, 6 months total

Study Arms (2)

AI-Based Lifestyle Recommendations Group

EXPERIMENTAL

Participants in this group receive AI-based, personalized lifestyle recommendations based on analysis of their activity tracker and blood pressure data.

Behavioral: AI-Based Lifestyle Recommendations

Control Group

ACTIVE COMPARATOR

Participants in this group do not receive the lifestyle recommendations, but are provided with an identical activity tracker and blood pressure monitor.

Other: No Lifestyle Recommendations

Interventions

AI-Based Lifestyle RecommendationsBEHAVIORAL

The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.

AI-Based Lifestyle Recommendations Group
No Lifestyle RecommendationsOTHER

The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.

Control Group

Eligibility Criteria

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

You may qualify if:

  • age ≥18 years
  • SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office
  • speaking and reading English
  • having an iPhone 8 or newer or an Android x or newer

You may not qualify if:

  • currently taking antihypertensive medication
  • 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 Diego

La Jolla, California, 92093, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Sujit Dey, PhD

CONTACT

8587617518dey@eng.ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2020

First Posted

September 10, 2020

Study Start

October 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)