UMIN-CTR Clinical Trial

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

Diabetes, CKS, CVD, Sleep disorder, High stress, Metabolic syndrome

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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, and other who are required to apply the behavior modification program

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

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

Name of contact person

1st name	Ayako
Middle name
Last name	Toyoshima

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

Homepage URL

Email

d161682@hiroshima-u.ac.jp

Institute

Graduate School of Biomedical and Health Sciences

Institute

Department

Personal name

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2019

Year

03

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

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

Recruitment status

Terminated

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

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

03

Month

17

Day

Last modified on

2020

Year

06

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041271