UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059951 |
|---|---|
| Receipt number | R000068574 |
| Scientific Title | Examination of Lifestyle Improvements for Diabetes Prevention and Enhancement of Specific Health Guidance Implementation Rates Using Individualized Health Support Apps Adapted to Diverse Lifestyles |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/02 20:04:16 |
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Basic information
Public title
Examination of Lifestyle Improvements for Diabetes Prevention and Enhancement of Specific Health Guidance Implementation Rates Using Individualized Health Support Apps Adapted to Diverse Lifestyles
Acronym
LIFE-APP study
Lifestyle Diversity-Oriented Personalized Health Support App for Diabetes Mellitus prevention
Scientific Title
Examination of Lifestyle Improvements for Diabetes Prevention and Enhancement of Specific Health Guidance Implementation Rates Using Individualized Health Support Apps Adapted to Diverse Lifestyles
Scientific Title:Acronym
LIFE-APP study
Lifestyle Diversity-Oriented Personalized Health Support App for Diabetes Mellitus prevention
Region
| Japan |
Condition
Condition
Health checkup examinees with BMI22 kg/m2 who are at increased risk of lifestyle-related diseases, particularly type 2 diabetes.
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of distributing a personalized lifestyle-support smartphone application to health checkup examinees for improving the implementation rate of specific health guidance and promoting lifestyle modification for the prevention of diabetes, as well as examining its feasibility in routine practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Change in anthropometric parameters (body weight, waist circumference, and body mass index [BMI]) between Visit 1 (baseline health checkup) and Visit 2 (follow-up health checkup).
Key secondary outcomes
Changes in blood pressure and body composition (InBody measurements) between Visit 1 and Visit 2.Changes in laboratory parameters between Visit 1 and Visit 2, including complete blood count, AST, ALT, GGT, ALP, LDH, total bilirubin, BUN, creatinine, LDL cholesterol, HDL cholesterol, total cholesterol, serum triglycerides, plasma glucose, HbA1c, uric acid, electrolytes, and urinalysis parameters.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
X
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergoing a health check-up (specific health check-up, legally mandated health check-up, or comprehensive medical check-up).
Able to understand the study information and provide informed consent for participation via the smartphone application of their own free will.
Aged between 18 and 90 years.
Body mass index (BMI) 22 kg/m.
Owning a smartphone on which the study application can be installed and used.
Key exclusion criteria
Women who are pregnant or may be pregnant.
Individuals with diabetes, renal disease or other conditions who require medically supervised dietary therapy.
Body mass index (BMI) < 22 kg/m.
Deemed inappropriate for study participation by the attending physician or principal investigator.
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endoclinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku
TEL
0752515506
mhama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endoclinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kamigyo-ku
TEL
0752515506
Homepage URL
mhama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of medicine
Address
465, Kajii-cho, Kamigyo-ku
Tel
0752515506
mhama@koto.kpu-m.ac.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
京都府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068574
