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Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial

Evaluation of Behavioral Change Effects Induced by an AI-Enabled Health Record Application: A Non-Inferiority Randomized Controlled Trial - Evaluating Behavioral Change Effects of an AI Application: A Non-Inferiority RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061041
Enrollment
142
Registered
2026-04-01
Start date
2025-12-05
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None listed

Interventions

The AI health application will be installed on each participant&#39
s smartphone, and goal setting and health management during the study period will be fully delegated to the app. Use of the AI health application will be prohibited, and participants will be asked to

Sponsors

University of Yamanashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among men and women aged 30 to 39 years who work at the implementation site, those who meet the following criteria: 1. A Body Mass Index (BMI) of 23 or higher at this year's health checkup. 2. Possession of a personal smartphone. 3. Written informed consent was obtained for participation in this study.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will be excluded: 1. Individuals who, due to physical, mental, or other reasons, are unable to receive health guidance from the staff or are expected to have limitations in participating in the intervention.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Change in behavioral modification points before and after the intervention in each group. (These points are designed with reference to the behavioral modification criteria defined in the 4th Term of the Japanese Specific Health Guidance program.)

Secondary

MeasureTime frame
Secondary Outcomes Changes in body weight, BMI, waist circumference, and questionnaire responses before and after the intervention in each group.

Countries

Japan

Contacts

Public ContactDaisuke Hanawa

University of Yamanashi Department of Health Sciences

d.hanawa@yamanashi.ac.jp055-273-9566

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026