UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057549 |
|---|---|
| Receipt number | R000065754 |
| Scientific Title | AMEND-IT2: A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes /Metabolic Syndrome Patients through IoT-based Self Monitoring System 2 |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/08 10:56:41 |
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Basic information
Public title
AMEND-IT2: A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes /Metabolic Syndrome Patients through IoT-based Self Monitoring System 2
Acronym
AMEND-IT2
Scientific Title
AMEND-IT2: A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes /Metabolic Syndrome Patients through IoT-based Self Monitoring System 2
Scientific Title:Acronym
AMEND-IT2
Region
| Japan |
Condition
Condition
Metabolic Syndrome
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although there are many cases of metabolic syndrome, there are many cases who do not receive health checkups and subsequent guidance, and it is desirable to develop a uniform and effective method of providing improved lifestyle guidance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To test whether lifestyle modification guidance by a dietitian using an AI dietetic assistant can reduce weight after 3 months of guidance.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
All research subjects will download "Remokara" 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 taking pictures (taken with the smartphone camera and aggregated by Remokara) on a daily basis. During the intervention period, participants receive messages of support and reminders from a dietitian through Remokara. Chats with the dietitian are once a week. In addition, the dietitian will access the administrator's screen in "Remokara" 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key 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)"
Key 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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohsugi |
Organization
National Center for Global Health and Medicine
Division name
Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
moosugi@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohsugi |
Organization
National Center for Global Health and Medicine
Division name
Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-718
Homepage URL
dm-inf1@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Health Research Promotion Bureau
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Healch and Medicine
Address
1-21-1 Toyama, Shinjiku-Ku, Tokyo, Japan
Tel
03-3202-7181/
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035900
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035900
Number of participants that the trial has enrolled
192
Results
A 3-month remote lifestyle intervention was conducted for the final 192 patients, and a weight loss of approximately 2 kilograms was observed in the pre- and post-comparison.
Results date posted
| 2025 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age 54, average BMI 25.9
Participant flow
196 were incorporated and 196 completed the exam.
Adverse events
none
Outcome measures
Change in body weight after 3 months of intervention
Change in abdominal circumference after 3 months of intervention
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065754
