UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042604
Receipt number R000048621
Scientific Title Randomized controlled trial on the impact of remote support by Occupational Health Nurses on the sustainability of health promotion activities using ICT devices (pilot study)
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/30 22:17:08

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Basic information

Public title

Randomized controlled trial on the impact of remote support by Occupational Health Nurses on the sustainability of health promotion activities using ICT devices (pilot study)

Acronym

Randomized controlled trial on the impact of remote support by Occupational Health Nurses on the sustainability of health promotion activities using ICT devices (pilot study)

Scientific Title

Randomized controlled trial on the impact of remote support by Occupational Health Nurses on the sustainability of health promotion activities using ICT devices (pilot study)

Scientific Title:Acronym

Randomized controlled trial on the impact of remote support by Occupational Health Nurses on the sustainability of health promotion activities using ICT devices (pilot study)

Region

Japan


Condition

Condition

Lack of physical activity

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we will distribute wearable devices and gamify competitive elements for the purpose of behavior change such as increase in physical activity and weight loss in small-scale decentralized workplaces where occupational health services tend to be in short supply. .. In addition to this, by providing remote support by occupational health nurses, it is possible to reduce dropouts and clarify whether behavior change can be sustained compared to the distribution of wearable devices and gamification alone. The purpose is to confirm the feasibility of intervention studies to be conducted in the future (Feasibility test).
This study can be expected to promote behavior change of workers in small-scale decentralized workplaces where occupational health services are less active.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical activity (comparison between the average of weeks 1 to 4 and the average of weeks 21 to 24)

Key secondary outcomes

Weight, application utilization, wearable device utilization, sleep time, 5 health literacy items, exercise frequency of 30 minutes or more, time of walking or physical activity per day, WFun (questionnaire on labor dysfunction)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention program for intervention groups:
Nursing support: Three occupational health nurses provide individual semi-structured guidance in the 1st to 4th, 9th to 12th, and 17th to 20th weeks, remotely for about 15 minutes each time. Pre-educate occupational health nurses to standardize interventions.
Hearing content: Application usage, wearable device usage, activity (steps), weight
Guidance content: Goal setting for activity amount (steps) improvement / weight loss, health guidance for activity amount (steps) improvement / weight loss

Interventions/Control_2

Control group: No special intervention was given to subjects who met the eligibility conditions.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Select one that meets all of the following conditions
1. BMI 25 or above
2. In the 2020 specific health checkup (June-September), they answered that they had "almost no time" for walking or physical activity per day.
3. In the 2020 specific health checkup (June-September), the frequency of exercise for 30 minutes or more was "less than one day a week".

Key exclusion criteria

1. Persons who are restricted from walking exercise by their doctor (during cancer treatment, after myocardial infarction / stroke, other diseases)
2. Persons whose weight loss is prohibited by the attending physician (during cancer treatment, COPD treatment, other diseases)
3. Persons who do not have a smartphone that can be linked

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Tomohisa
Middle name
Last name Nagata

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Occupational Health Practice and Management, Institute of industrial Ecological Sciences

Zip code

807-8555

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyusyu city

TEL

093-603-1611

Email

tomohisa@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Ko
Middle name
Last name Hiraoka

Organization

Komatsu, LTD.

Division name

Health Promotion Center

Zip code

107-8414

Address

2-3-6 Akasaka, Minato-ku

TEL

03-5561-2627

Homepage URL


Email

kou_hiraoka@global.komatsu


Sponsor or person

Institute

Department of Occupational Health Practice and Management, Institute of industrial Ecological Sciences, University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

None

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

Institutional Review Board of UOEH

Address

1-1 Iseigaoka, Yahatanishi-ku, Kitakyusyu city

Tel

093-603-1611

Email

y-abe@pub.uoeh-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



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 01 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

24

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 08 Month 28 Day

Date of IRB

2020 Year 10 Month 21 Day

Anticipated trial start date

2020 Year 11 Month 01 Day

Last follow-up date

2023 Year 10 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

2020 Year 11 Month 30 Day

Last modified on

2020 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048621


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name