UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052685 |
|---|---|
| Receipt number | R000060118 |
| Scientific Title | Randomized Controlled Trial of an Intervention using Genetic Information and AI Health App for People with Elevated Blood Pressure |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2025/10/19 18:13:12 |
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Basic information
Public title
Randomized Controlled Trial of an Intervention using Genetic Information and AI Health App for People with Elevated Blood Pressure
Acronym
CALO mama Plus RCT
Scientific Title
Randomized Controlled Trial of an Intervention using Genetic Information and AI Health App for People with Elevated Blood Pressure
Scientific Title:Acronym
CALO mama Plus RCT
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to examine the effect of sending personalized advice through the AI health app "CALO mama Plus" on diet in individuals with salt-sensitive genotypes and elevated blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salt intake
Key secondary outcomes
Health awareness, systolic and diastolic blood pressure, and body mass index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will be notified that they have the salt-sensitive genotype and required to record their daily diet in "CALO mama Plus." In addition, information and quiz on salt reduction will be distributed for the intervention group.
Interventions/Control_2
The control group (1) will receive no intervention.
Interventions/Control_3
The control group (2) will be required to record their daily diet in "CALO mama Plus," but information and quiz on salt reduction will not be distributed. To consider the effect of simply using the app, an auxiliary comparison between the intervention group and control group (2) will be conducted.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Persons between 20 and 65 years of age
- Those with angiotensinogen gene polymorphism (AGT M235T)
- Those who have an elevated blood pressure (systolic blood pressure 120 or higher, or diastolic blood pressure 80 or higher) in a health checkup during 2022FY or 2023FY
- Those who have not used "CALO mama Plus" before
- Those who submitted urine and responded to the questionnaire before the intervention
Key exclusion criteria
- Pregnant or nursing mothers
- Those who cannot use "CALO mama Plus" because they do not have a smartphone (iPhone or Android)
- Those who cannot understand Japanese
- Consenters whom the investigators deem inappropriate as subjects of the study
Target sample size
311
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Inoue |
Organization
Graduate School of Medicine and School of Public Health, Kyoto University
Division name
Department of Social Epidemiology
Zip code
606-8315
Address
Floor 2, Science Frontier Laboratory, Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
+81-(0)75-753-4355
inoue.kosuke.2j@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koryu |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Medicine and School of Public Health, Kyoto University
Division name
Department of Social Epidemiology
Zip code
606-8315
Address
Floor 2, Science Frontier Laboratory, Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
+81-(0)75-753-4355
Homepage URL
sato.koryu.8i@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Koryu Sato
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOSHIBA CORPORATION, Wellmira Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto University Graduate School and Faculty of Medicine
Address
Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
https://cdn.jamanetwork.com/ama/content_public/journal/jamanetworkopen/939703/zoi251034supp1_prod_17
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2840279
Number of participants that the trial has enrolled
312
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 10 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 12 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060118
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/04/16 | 240705_IRB研究計画書_食塩感受性RCT.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/04/16 | Data Description.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/04/16 | share.csv |
Single case data URL
Value
https://center6.umin.ac.jp/ice/60118
