Skip to content

AMEND-IT2: A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes /Metabolic Syndrome Patients through IoT-based Self Monitoring System 2

AMEND-IT2: A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes /Metabolic Syndrome Patients through IoT-based Self Monitoring System 2 - AMEND-IT2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057549
Enrollment
200
Registered
2025-04-08
Start date
2022-09-05
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

Metabolic Syndrome

Interventions

All research subjects will download &quot
Remokara&quot
to their own smartphones and enter the information necessary to use Remokara. Study subjects will record their steps (measured by Remokara), weight (entered into Remokara by themselves), and meals by
s screen in &quot
to check graphs of measurement data and summaries of lifestyle habits, and use the daily data of the research subjects as materials for specific health guidance.

Sponsors

National Center for Global Health and Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 1. 40 years old or older and less than 65 years old 2) Obesity risk* (1) Abdominal circumference (male: 85 cm or more, female: 90 cm or more) (2) BMI: 25 or more 3) Additional risk* (1) Blood sugar: Fasting blood sugar 100 mg/dL or more, or HbA1c 5.6% or more, or if unavoidable, blood sugar 100 mg/dL or more at any time (2) Lipids: triglycerides 150 mg/dL or more, or HDL cholesterol less than 40 mg/dL (3) Blood pressure: systolic 130 mmHg or more, or diastolic 85 mmHg or more (4) Smoking history *Among those between 40 and 65 years old, the following conditions in combination with the above "obesity risk" and "additional risk" are eligible for active support A: Those who fall under "obesity risk (1)" + "two or more additional risks (1)(2)(3)" B: Those who fall under "obesity risk (1)" + "one additional risk (1)(2)(3)\" + "additional risk (4)" C: Those who fall under "obesity risk (2) only" + "three additional risks (1)(2)(3)" D: Those who fall under "obesity risk (2) only" + "two additional risks (1)(2)(3)"

Exclusion criteria

Exclusion criteria: 1. patients with serious hepatic disorder, renal disorder, malignancy (recurrence-free for less than 5 years), or infectious disease 2. patients with obvious diabetes mellitus who are attending a medical institution and are being treated with diabetic drugs, or for whom such attendance and treatment are deemed appropriate 3. patients who have developed cardiovascular disease within 6 months 4. patients with uncompensated heart failure 5. pregnant patients

Design outcomes

Primary

MeasureTime frame
To test whether lifestyle modification guidance by a dietitian using an AI dietetic assistant can reduce weight after 3 months of guidance.

Countries

Japan

Contacts

Public ContactMitsuru Ohsugi

National Center for Global Health and Medicine Diabetes and Metabolism Information Center

dm-inf1@hosp.ncgm.go.jp03-3202-718

Outcome results

None listed

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