UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047274 |
|---|---|
| Receipt number | R000048619 |
| 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 | 2022/03/24 |
| Last modified on | 2022/03/24 06:00:28 |
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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 -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
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
kou_hiraoka@global.komatsu
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048619
