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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 5 January 2021
Main ID:  JPRN-UMIN000042604
Date of registration: 01/12/2020
Prospective Registration: No
Primary sponsor: Department of Occupational Health Practice and Management, Institute of industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
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)
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) - 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 first enrolment: 2020/11/01
Target sample size: 24
Recruitment status: Complete: follow-up continuing
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048621
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Tomohisa    Nagata
Address:  1-1 Iseigaoka, Yahatanishi-ku, Kitakyusyu city Japan
Telephone: 093-603-1611
Email: tomohisa@med.uoeh-u.ac.jp
Affiliation:  University of Occupational and Environmental Health, Japan Department of Occupational Health Practice and Management, Institute of industrial Ecological Sciences
Name: Ko    Hiraoka
Address:  2-3-6 Akasaka, Minato-ku 107-8414 Japan
Telephone: 03-5561-2627
Email: kou_hiraoka@global.komatsu
Affiliation:  Komatsu, LTD. Health Promotion Center
Key inclusion & exclusion criteria
Inclusion criteria:
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


Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Lack of physical activity
Intervention(s)
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
Control group: No special intervention was given to subjects who met the eligibility conditions.
Primary Outcome(s)
Physical activity (comparison between the average of weeks 1 to 4 and the average of weeks 21 to 24)
Secondary Outcome(s)
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)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 21/10/2020
Contact:
y-abe@pub.uoeh-u.ac.jp
Institutional Review Board of UOEH
093-603-1611
y-abe@pub.uoeh-u.ac.jp
Results
Results available:
Date Posted:
Date Completed: 31/10/2023
URL:
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