UMIN-CTR Clinical Trial

Basic information
Public title	Download Useful Kind of App for Your Health Study
Acronym	DOUKI-APP STUDY
Scientific Title	Multicenter randomized controlled trial aimed at improving effects of the motivational support
Scientific Title:Acronym	DOUKI-APP STUDY
Region	Japan

Condition
Condition	metabolic syndrome
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of adding several apps to the subjects who have not been effective in the past specific health guidance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Percentage of app users after 3 months
Key secondary outcomes	Weight reduction and its rate after 3 months, improvement of clinical test values after 1 year

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	In addition to motivational support, support the introduction of apps according to the action goals at the time of the first interview
Interventions/Control_2	Motivational support as usual
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	40 years-old <=
Age-upper limit	64 years-old >
Gender	Male and Female
Key inclusion criteria	Among middle-aged workers who are eligible for the specific guidance (motivational support), those who participated in specific health guidance in the past
Key exclusion criteria	Patients treated for serious illnesses such as cancer, cardiovascular disease, renal failure
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kazuyo Middle name Last name Tsushita
Organization	Kagawa Nutrition University
Division name	Graduate Schools of Nutrition Sciences
Zip code	350-0288
Address	3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL	049-282-3717
Email	tsushita.kazuyo@eiyo.ac.jp

Public contact
Name of contact person	1st name Kazuyo Middle name Last name Tsushita
Organization	Kagawa Nutrition University
Division name	Graduate Schools of Nutrition Sciences
Zip code	350-0288
Address	3-9-21, Chiyoda, Sakao-city, Saitama, Japan
TEL	049-282-3717
Homepage URL	http://www.ktsushita.com/cn4/4kenkyu.html
Email	tsushita.kazuyo@eiyo.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Review Committee of Kagawa Nutrition University
Address	3-9-21, Chiyoda, Sakao-city, Saitama, Japan
Tel	049-282-7331
Email	kenshien@eiyo.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	2021 Year 01 Month 20 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	2021 Year 01 Month 03 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2021 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049078