UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052374 |
|---|---|
| Receipt number | R000059791 |
| Scientific Title | An implementation study of a smartphone application "ASHARE" to promote physical activity which uses a deep learning model for passive monitoring of depression and anxiety among workers: A non-randomized controlled trial |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/11/06 08:08:54 |
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Basic information
Public title
An implementation study of a smartphone application "ASHARE" to promote physical activity which uses a deep learning model for passive monitoring of depression and anxiety among workers: A non-randomized controlled trial
Acronym
The "ASHARE" project for the implementation
Scientific Title
An implementation study of a smartphone application "ASHARE" to promote physical activity which uses a deep learning model for passive monitoring of depression and anxiety among workers: A non-randomized controlled trial
Scientific Title:Acronym
An implementation study of the "ASHARE": A non-randomized controlled trial
Region
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to conduct a hybrid study that examines the effects of a smartphone application "ASHARE" on physical activity, depression and anxiety, and implementation outcomes among workers.
A three-month intervention program will be provided to workers who meet eligibility criteria. Participants will be solicited at each workplace, and a baseline survey will be conducted after enrollment. Half of the workplaces will be assigned to the intervention group, and the other half will be assigned to the control group as a treatment as usual, which will offer face-to-face intervention programs. A follow-up survey will be conducted after the interventions (3 months later). Acceptability, appropriateness, and feasibility of the intervention programs will also be measured by the workplace health promotion personnel.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity (the Global Physical Activity Questionnaire, GPAQ)
Key secondary outcomes
Depression and anxiety (K6)
Usefulness evaluation: acceptability, appropriateness, feasibility, satisfaction of the program
The duration of digitally recorded physical activity (for the intervention group only)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Use of the smartphone application "ASHARE"
The participants who belong to workplaces assigned to the intervention group will be asked to install and use the smartphone application for 3 months. The application has the following functions. 1) prediction and monitoring of users' depressed mood for the next day, 2) notification of prediction results and advice for physical activity, and 3) reference of activity patterns among users.
Interventions/Control_2
A face-to-face physical activity promotion program as a treatment as usual
Workplaces assigned to the control group will receive a program that combines multiple methods to improve work environments for 3 months. The effectiveness of the program in promoting physical activity was confirmed in the previous study (Watanabe et al., 2018, Int J Behav Med). This program includes multiple environmental adjustment methods such as policy-making and declaration, notifications provided on intrawebsite/electronic bulletin board systems, Individual competition of physical activity within the worksite, and Psychological education to increase self-regulation for physical activity.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for workers:
1) workers over 18 years old
2) can answer questionnaires written in Japanese
3) can use their private smartphone on off-duty to access the intervention programs
Inclusion criteria for the workplace health promotion personnel.
A representative will be selected from among the workers who meet the following criteria:
1) a worker in charge of human resources, labor affairs, general affairs, or health management
2) a worker in charge of promoting mental health in the workplace according to the guidelines by the Ministry of Health, Labor and Welfare, Japan.
Key exclusion criteria
1) are absent or have been absent past the 12 months
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Public Health
Zip code
252-0374
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan
TEL
+81-42-778-9352
kzwatan@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Public Health
Zip code
252-0374
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan
TEL
+81-42-778-9352
Homepage URL
kzwatan@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Kazuhiro Watanabe
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization (KMEO)
Address
1-15-1 Kitazato, Minami-ku, Sagamihara 252-0373, Japan
Tel
+81-42-778-8273
rinri@med.kitasato-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
| 2023 | Year | 10 | Month | 10 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059791
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