UMIN-CTR Clinical Trial

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
Email	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
Email	nyahagit-ky@umin.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053861