UMIN-CTR Clinical Trial

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 -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	By qualified public health nurses Remote health guidance
Interventions/Control_2	3 times in 6 months, 15-30 minutes per session
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	criteria BMI 25 or higher Respondents who answered hardly any time for walking or physical activity per day in the health checkup (June-September) in FY2020. In the questionnaire of the health checkup (June-September) in FY2020, the frequency of exercise for more than 30 minutes is less than one day a week.
Key exclusion criteria	Patients who are restricted by their physician to walking level exercise (during cancer treatment, after myocardial infarction/stroke, or other illnesses) Those who are prohibited from losing weight by their doctor (under treatment for cancer, COPD, or other illnesses) Do not own a smartphone that can be linked to the Internet
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
Division name	Institute of Occupational and Environmental Science, Department of Occupational Health Management
Zip code	807-8555
Address	Kitakyusyu-cty Yahatanishiku Iseigaoka 1-1
TEL	0936031611
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	Minatoku Akasaka 2-3-6
TEL	0355612627
Homepage URL
Email	kou_hiraoka@global.komatsu

Sponsor
Institute	University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization	Komatsu Health Insurance Association
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	Ethics Committee of Occupational and Environmental Medicine
Address	Kitakyusyu-cty Yahatanishiku Iseigaoka 1-1
Tel	036031611
Email	tomohisa@med.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	2022 Year 03 Month 24 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	23
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 11 Month 30 Day
Date of IRB	2022 Year 11 Month 29 Day
Anticipated trial start date	2020 Year 11 Month 30 Day
Last follow-up date	2021 Year 05 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	2022 Year 03 Month 24 Day
Last modified on	2022 Year 03 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048619