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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: AI-Driven Lifestyle Coaching Program

• Registration Number: NCT06337734
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AI-Driven Lifestyle Coaching Group	AI-Driven Lifestyle Coaching Program	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average weekly percentage of active participants measuring their BP	24 weeks
Average weekly percentage of active participants syncing their wearable	24 weeks
Average weekly percentage of active participants answering the mobile app questionnaire	24 weeks
Number of manual clinician outreaches based on the escalation rules set for the study	24 weeks

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States