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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036226
Receipt No. R000041271
Scientific Title Examination of effects and feasibility of behavior change programs using IoT and AI contributing to mental and physical health promotion of employees: Non-randomized, single-arm, pre-and-post design trial (A Pilot Study)
Date of disclosure of the study information 2019/03/18
Last modified on 2019/07/09

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Basic information
Public title Examination of effects and feasibility of behavior change programs using IoT and AI contributing to mental and physical health promotion of employees
Acronym The effects of IoT-based behavioral change program for employees
Scientific Title Examination of effects and feasibility of behavior change programs using IoT and AI contributing to mental and physical health promotion of employees: Non-randomized, single-arm, pre-and-post design trial (A Pilot Study)
Scientific Title:Acronym The effects of IoT-based behavioral change program for employees (A Pilot Study)
Region
Japan

Condition
Condition Diabetes, CKS, CVD, Sleep disorder, High stress, Metabolic syndrome
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Develop and implement IoT-based behavioral change programs to solve employee health problems for small and medium-sized companies that do not require the placement of occupational physicians or occupational health nurses, and evaluate the effects and the feasibility.
Basic objectives2 Others
Basic objectives -Others Effects and Feasibility of the programs
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes As it is an exploratory study, multiple evaluation items are set.
1. Engagement: Program participation agreement rate (at registration) and continuation rate (monthly, 3 months)
2. Behavior change degree (change stage: lifestyle: diet, exercise, smoking cessation, alcohol saving, self-monitoring, medication, regular hospital visit)
3. Implementation rate of self-monitoring (count of self-measurement count and number of feedback)
4. Physiological and behavioral indicators (calorie consumption, sleep, meal management, automatic meal time, pulse / heart rate, conversation volume, activity) Use only collected data items
5. Sleep improvement: Pittsburgh Sleep Quality Index (PSQI)
6. Operational Feasibility of Behavior Change Program Using IoT: Function of IoT and AI Application: Convenience, Satisfaction of Overall Application
7. Qualitative evaluation: Interveiws with management, health management staff, disease management company, association Kenpo, health management adviser)
Key secondary outcomes The following data collected in epidemiological research (health management evaluation) will also be evaluated secondarily.
-Physiological indicators: Advanced Glycation End Products (AGEs), blood pressure, body weight
-Work engagement (UWES: Utrecht Work Engagement Scale) score
-Presentism/absenteeism (WHO-HPQ, short version) score
-Stress (work stress questionnaire (stress check) score
-Health literacy scale-Degree of interest in one's own body: Likert scale (0 to 10)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1. Disease management program for diabetes, CKD, CVD
2. Improvement of sleep and stress program
3. Antiaging program
At first, a face-to-face health education by a nurse is provided. Then participants wear IoT devices. Data are wired to the participants, disease management company, and their physicians (when needed). The participants receive automatic feedback messages based on their data from the disease management company. They are required to change their health-related behavior. All of the programs were 3-month long, and if needed, participants repeat one more time.
Wearable devices: Participants choose either one: Charge 3 (Fitbit), Silmee TM W20 (TDK), MOVEBAND 3R (NTT Docomo),GoBe2(HEALBE). FreeStyle Libre
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 Employees from small and midium-sized companies (ACT CHUSHOKU, Co. LTD., Miyoshi Kamotsu Express, FRESTA, Co., LTD., TSUBAME Travel Co., LTD) .
(Applicable for all 3 programs)
1. Employees listed above who have consented to participate
2. Those who can participate for 3 months after consent
3. A person who has a device such as a smartphone, tablet terminal, personal computer, etc. that can receive feedback on transmitted data and alert messages
Disease Management program: having diagnosis of diatetes, CKD, CVD
Improvement of sleep and stress program: having sleep-disorders (self-reported), feeling high stress, depression
Antiaging program: Metabolic symdrom, hypertension, Dyslipidemia, BMI > 25, smoker, excessive alcohol drinker
Key exclusion criteria 1 Those who can not agree to participation
2 Those who have not been enrolled in the research site for more than one month after consenting
3. Person who has treatment and situation that should be prioritized over this program
4 Persons who are considered by the health management personnel of the company and/or researchers that there is a problem and it is difficult to continue the program
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima
TEL 082-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name KANA
Middle name
Last name KAZAWA
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Kasumi 1-2-3, Minami-ku, Hiroshima
TEL 082-257-5382
Homepage URL
Email kkazawa@hiroshima-u.ac.jp

Sponsor
Institute Graduate School of Biomedical and Health Sciences
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University Research Ethics Committee
Address Kasumi 1-2-3, Minami-ku, Hiroshima
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.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 株式会社フレスタ(広島県)、アクト中食株式会社(広島県)、つばめ交通株式会社(広島県)、三次貨物運輸(広島県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 18 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
2018 Year 11 Month 14 Day
Date of IRB
2018 Year 12 Month 13 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 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
2019 Year 03 Month 17 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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