UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047228 |
|---|---|
| Receipt number | R000053861 |
| Scientific Title | Pilot study using a personalized data-nutrition management application on cell phone |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/19 13:20:47 |
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Basic information
Public title
Pilot study using a personalized data-nutrition management application on cell phone
Acronym
Data-nutrition pilot study
Scientific Title
Pilot study using a personalized data-nutrition management application on cell phone
Scientific Title:Acronym
Data-nutrition pilot study
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Type2 diabetes or healthy adults
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will observe how the use of dietary management support apps brings about changes in testers using food behavior logs and standardized questionnaires, and use this information to estimate the effects of app use. We further aim to develop apps useful for dietary management of lifestyle-related diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in intake of nutrients and foods during 12 weeks using BDHQ
Changes in HbA1c
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons who have agreed with electromagnetic consent to participate in the study
2) Persons who own and can operate a smartphone (iOS, Android)
3) Persons who have "Diabetes (Type 2)", "Concerned about a number in a health checkup", or "Need nutrition support" among the "Delicious Healthy Diet Themes".
4) New users of the "Delicious Healthy App"
Key exclusion criteria
1) Persons requiring exercise restriction for treatment
2) Persons with diseases other than those indicated in the selection criteria
3) Pregnant or possibly pregnant
4) Persons with mental disorders
5) Persons who are judged by the principal investigator to be inappropriate for inclusion in the study
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Yahagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
0298533900
nyahagit-ky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Yahagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
0298533900
Homepage URL
nyahagit-ky@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Oishi kenko Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, University of Tsukuba Hospital
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
Tel
0298533914
rinshokenkyu@un.tsukuba.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
| 2022 | 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
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
New users of the "Oishi Kenko" smartphone application (people with and without impaired glucose tolerance) will be asked to use the "Oishi Kenko" application during the research period (3 months) and complete a standardized questionnaire (items related to dietary habits and quality of life) and other questionnaires every 4 weeks. The participants will be also asked to self-report their weight and HbA1c values.
Management information
Registered date
| 2022 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
