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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042604
Receipt No. 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

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

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
URL(English) https://upload.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


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