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An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension

The Effect of an Artificial Intelligence-based, Autonomous, Digital Health Intervention Using Precise Lifestyle Guidance on Blood Pressure in Adults With Hypertension: Single-Arm Nonrandomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06337734
Enrollment
141
Registered
2024-03-29
Start date
2021-11-01
Completion date
2023-08-01
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management.

Interventions

BEHAVIORALAI-Driven Lifestyle Coaching Program

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

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥18 years * Stage 2 hypertension based on their most recent clinical measurement (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg per the 2017 American College of Cardiology/American Heart Association guidelines) * Speaking and reading English * Having an Apple iPhone 6s or later, or an Android phone running Android 8.0 or later

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

Design outcomes

Primary

MeasureTime frame
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks24 weeks
Average change in DBP from baseline to 24 weeks24 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks12 weeks
Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks24 weeks
Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks12 weeks
Average change in systolic blood pressure (SBP) from baseline to 12 weeks12 weeks
Average change in diastolic blood pressure (DBP) from baseline to 12 weeks12 weeks
Average change in SBP from baseline to 24 weeks24 weeks

Secondary

MeasureTime frame
Average weekly percentage of active participants syncing their wearable24 weeks
Average weekly percentage of active participants answering the mobile app questionnaire24 weeks
Number of manual clinician outreaches based on the escalation rules set for the study24 weeks
Average weekly percentage of active participants measuring their BP24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026