UMIN-CTR Clinical Trial

Basic information
Public title	Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Acronym	Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Scientific Title	Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Scientific Title:Acronym	Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Region	Japan

Condition
Condition	Subjects of Specific Health Guidance
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In addition to evaluating and examining the differences in improvement effects when health guidance provided by professionals is combined with support for lifestyle improvement using applications, we will analyze various parameters, such as the goals set, the status of achievement, and the use of applications, to examine factors for improving improvement effects. In addition, we will analyze various parameters, such as the goals set, achievement status, and application usage, to study the factors for improving the improvement effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage change in body weight and body composition parameters after 3 and 6 months compared to the initial guidance for each subject
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Subjects subject to motivational support and using the application
Interventions/Control_2	Subjects subject to motivational support and not using the application.
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	60 years-old >
Gender	Male
Key inclusion criteria	1) Subjects of motivational support and active support for specific health guidance at Mitsui Chemicals, Inc. 2) Those who have read and understood the consent explanatory document for this study and have obtained written consent from the individual.
Key exclusion criteria	None in particular
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ikuyo Middle name Last name Ichi
Organization	Ochanomizu University
Division name	Facurty of Core Research
Zip code	112-8610
Address	2-1-1, Otsuka, Bunkyo-ku, Tokyo
TEL	03-5978-5750
Email	ichi.ikuyo@ocha.ac.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Furuoku
Organization	Habitus Care Inc.
Division name	Operations department
Zip code	105-0012
Address	Seiwa Daimon Building, 1-1-21 Shiba Daimon, Minato-ku, Tokyo
TEL	03-6253-2654
Homepage URL
Email	furuoku@habituscare.co.jp

Sponsor
Institute	Ochanomizu University
Institute
Department

Funding Source
Organization	Habitus Care 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	Ochanomizu University Ethics Committee
Address	2-1-1, Otsuka, Bunkyo-ku, Tokyo
Tel	03-5978-5750
Email	ichi.ikuyo@ocha.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 05 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	40
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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 09 Month 30 Day
Anticipated trial start date	2021 Year 01 Month 07 Day
Last follow-up date	2021 Year 06 Month 07 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 05 Month 19 Day
Last modified on	2021 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050550