UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study to examine the effectiveness of self-monitoring using applications for health management and to develop recommendations
Acronym	Intervention study to examine the effectiveness of self-monitoring using applications for health management
Scientific Title	Intervention study to examine the effectiveness of self-monitoring using applications for health management and to develop recommendations
Scientific Title:Acronym	Intervention study to examine the effectiveness of self-monitoring using applications for health management
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of self-monitoring using applications for health management on improving diet and health status and to develop effective recommendations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Food and nutrient intakes, body weight
Key secondary outcomes	Body composition, health status, diet and lifestyle

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Self-monitoring using applications for health management for eight weeks.
Interventions/Control_2	Self-monitoring using applications for health management for eight weeks, during the same period recommendations about diet and lifestyle will be sent out.
Interventions/Control_3	The control group does not self-monitor using the applications.
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	Those who work in an eligible office building.
Key exclusion criteria	Not applicable
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshiko Middle name Last name Kuwano
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL	054-264-5513
Email	kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Toshiko Middle name Last name Kuwano
Organization	University of Shizuoka
Division name	School of Food and Nutritional Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL	054-264-5513
Homepage URL
Email	kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	Research & Development Laboratories, Asahi Kasei Homes Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Research & Development Laboratories, Asahi Kasei Homes Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of the University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
Tel	054-264-5103
Email	tyous10@u-shizuoka-ken.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	旭化成ホームズ(株) 住宅総合技術研究所

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 26 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	38
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	Completed
Date of protocol fixation	2020 Year 08 Month 31 Day
Date of IRB	2020 Year 10 Month 14 Day
Anticipated trial start date	2020 Year 11 Month 30 Day
Last follow-up date	2021 Year 02 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 26 Day
Last modified on	2021 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048576