UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055505 |
|---|---|
| Receipt number | R000063426 |
| Scientific Title | A study for commercialization of diabetes prevention by a personalized health support app corresponding to diversity of lifestyles |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2026/07/12 08:04:12 |
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Basic information
Public title
A study for commercialization of diabetes prevention by a personalized health support app corresponding to diversity of lifestyles
Acronym
A study for commercialization of diabetes prevention by a personalized health support app corresponding to diversity of lifestyles
Scientific Title
A study for commercialization of diabetes prevention by a personalized health support app corresponding to diversity of lifestyles
Scientific Title:Acronym
A study for commercialization of diabetes prevention by a personalized health support app corresponding to diversity of lifestyles
Region
| Japan |
Condition
Condition
person receiving health checkups
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will distribute a smartphone application with health promotion functions with incentives to people who have undergone health checkups, and verify its usefulness in improving their lifestyles for diabetes prevention and its practical application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in physical findings (weight, abdominal circumference, BMI)
Key secondary outcomes
Changes in physical examination (blood pressure, body composition (Inbody) test), blood and urine tests (blood count, AST, ALT, GGT, ALP, LDH, T-bil, BUN, CRE, LDL cholesterol, HDL cholesterol, total cholesterol, serum triglycerides, blood sugar, HbA1c, uric acid, electrolytes, urine test )
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 |
Interventions/Control_1
Intervention to distribute a smartphone application (smartphone application, hereinafter referred to as application) researched and developed by the representative research institute, Delicious Health Corporation, to examinees of health checkups (specified health checkups, statutory health checkups, and physical examinations) at the joint research institute.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Persons receiving medical examinations at Asahi University Hospital, Kameoka Municipal Hospital, Shin-Oyama Municipal Hospital, and Takata Central Hospital
2) Persons who can obtain consent to participate in the research of their own free will from the individual via the application.
(iii) Age: 20 to 90 years old
Key exclusion criteria
1.Women who are pregnant or may become pregnant
2.BMI less than 22 kg/m2
3.Diabetics, kidney disease patients, and others who need to follow diet therapy under the guidance of a physician
4.People whose attending physician deems it inappropriate
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Nojiri |
Organization
Oishi Kenko Inc.
Division name
CEO
Zip code
103-0024
Address
3F Libra Building, 3-2 Nihonbashi Kobunacho, Chuo-ku, Tokyo
TEL
03-6661-0081
tetsuya@oishi-kenko.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hamada |
Organization
Oishi Kenko Inc.
Division name
Development Department
Zip code
103-0024
Address
3F Libra Building, 3-2 Nihonbashi Kobunacho, Chuo-ku, Tokyo
TEL
03-6661-0081
Homepage URL
https://corp.oishi-kenko.com/
manemone@oishi-kenko.com
Sponsor or person
Institute
Oishi Kenko Inc.
Institute
Department
Personal name
Tetsuya Nojiri
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oishi Kenko Inc.
Address
3F Libra Building, 3-2 Nihonbashi Kobunacho, Chuo-ku, Tokyo
Tel
03-6661-0081
tetsuya@oishi-kenko.com
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
朝日大学病院（岐阜県）、亀岡市立病院（京都府）、地方独立行政法人 新小山市民病院（栃木県）、医療法人すこやか 高田中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://corp.oishi-kenko.com/news/20260526-gakkai/
Publication of results
Partially published
Result
URL related to results and publications
https://corp.oishi-kenko.com/news/20260526-gakkai/
Number of participants that the trial has enrolled
149
Results
Across four sites, 255 individuals were approached, 149 consented, and 138 initiated app use. Sixty-three completed 90 days; after excluding one outlier, 62 were included in the primary analysis. Mean body weight and waist circumference decreased by 1.99 kg and 3.13 cm, respectively (both p<0.001). App use frequency correlated with weight change (Spearman rho=-0.34, p=0.008). Results were presented at the 69th Annual Meeting of the Japan Diabetes Society.
Results date posted
| 2025 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 138 participants who initiated app use, mean age was 46.6 years; 98 (71.0%) were male and 40 (29.0%) were female; mean BMI was 27.3 kg/m2; and 116 (84.0%) had received health guidance. After excluding one outlier, the final analysis set included 137 participants: 62 continuers and 75 non-continuers. Continuers/non-continuers had age 47 10/46 10 years, BMI 27.4 3.8/27.0 3.6 kg/m2, baseline weight 77 13/78 13 kg, baseline waist circumference 93 9/93 9 cm, male sex 43 (69%)/54 (72%), and prior health guidance 51 (82%)/65 (87%).
Participant flow
Across four sites, 255 individuals were approached and 149 provided electronic informed consent. Eleven did not initiate app use, and 138 initiated the app. Sixty-three completed follow-up at 90 7 days. After exclusion of one outlier, 62 participants formed the primary continued-use analysis cohort. The remaining 75 participants had no valid weight and waist circumference data at 90 7 days and were classified as non-continuers. The final analysis set included 137 participants.
Adverse events
Adverse events were not prespecified as an outcome or systematically collected; therefore, the incidence of adverse events was not evaluated.
Outcome measures
In the primary continued-use analysis cohort (N=62), mean change from baseline to 90 7 days was -1.99 kg for body weight (p 0.001) and -3.13 cm for waist circumference (p 0.001). Thirty-three participants achieved both prespecified targets of at least 2 kg and 2 cm reductions, and 59 participants (95.2%) showed a reduction in at least one measure. App use frequency was negatively correlated with weight change (Spearman rho=-0.34, p=0.008). Changes in BMI, blood pressure, body composition, and blood and urine laboratory measures registered as outcomes were not evaluated in the final analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063426
