Unique ID issued by UMIN | UMIN000052685 |
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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 | 2023/11/10 17:06:50 |
Randomized Controlled Trial of an Intervention using Genetic Information and AI Health App for People with Elevated Blood Pressure
CALO mama Plus RCT
Randomized Controlled Trial of an Intervention using Genetic Information and AI Health App for People with Elevated Blood Pressure
CALO mama Plus RCT
Japan |
Hypertension
Cardiology | Adult |
Others
YES
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.
Efficacy
Salt intake
Health awareness, systolic and diastolic blood pressure, and body mass index
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
3
Treatment
Other |
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.
The control group (1) will receive no intervention.
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.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
- 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 and diastolic blood pressure 80 or higher) in a health checkup during 2023
- Those who have not used "CALO mama Plus" before
- Those who submitted urine and responded to the questionnaire before the intervention
- 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
600
1st name | Koryu |
Middle name | |
Last name | Sato |
Graduate School of Medicine and School of Public Health, Kyoto University
Department of Social Epidemiology
606-8315
Floor 2, Science Frontier Laboratory, Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
+81-(0)75-753-4355
sato.koryu.8i@kyoto-u.ac.jp
1st name | Koryu |
Middle name | |
Last name | Sato |
Graduate School of Medicine and School of Public Health, Kyoto University
Department of Social Epidemiology
606-8315
Floor 2, Science Frontier Laboratory, Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
+81-(0)75-753-4355
sato.koryu.8i@kyoto-u.ac.jp
Kyoto University
Koryu Sato
Japan Agency for Medical Research and Development
Japanese Governmental office
TOSHIBA CORPORATION, Link & Communication Inc.
Ethics Committee, Kyoto University Graduate School and Faculty of Medicine
Yoshida-Konoecho, Sakyo-ku, Kyoto-shi, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
2023 | Year | 12 | Month | 18 | Day |
Unpublished
Preinitiation
2023 | Year | 11 | Month | 01 | Day |
2023 | Year | 12 | Month | 15 | Day |
2024 | Year | 06 | Month | 09 | Day |
2023 | Year | 11 | Month | 02 | Day |
2023 | Year | 11 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060118
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