Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062516) titled 'Effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being: a fully remote randomized controlled trial' on Aug. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Yamagata University
Condition:
Condition - N/A
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being outcomes.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the intervention group will install the "Well-Being YU" smartphone app and use it for 4 weeks. They will be asked to (1) set a personal health goal and (2) record nine health behaviors, three health condition items, and their daily happiness level each day throughout the intervention period.
Interventions/Control_2 - Participants assigned to the control group will continue their usual daily activities without using the "Well-Being YU" smartphone app during the 4-week study period.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Adults aged 40-64 years residing in Japan (equal numbers of men and women will be recruited within two age strata: 40-49 and 50-64 years).
2) Currently employed, defined as engaging in paid work for at least 20 hours per week.
3) Own a smartphone and have a personal LINE account, with regular use of the LINE application.
4) Able to understand written Japanese and independently complete web-based questionnaires.
5) Able to access and use the "Well-Being YU" smartphone app throughout the 4-week intervention period.
Key exclusion criteria - 1) Currently using another health promotion app or participating in a digital behavior change program.
2) Currently participating in an intensive health support program provided by their employer or other organization (e.g., Specific Health Guidance [Tokutei Hokenshido]).
3) Unable to participate in the study or complete web-based questionnaires due to a serious illness or poor health condition.
4) Unable to independently operate a smartphone or use the LINE application.
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 16 Day
Date of IRB - 2026 Year 07 Month 16 Day
Anticipated trial start date - 2026 Year 09 Month 10 Day
Last follow-up date - 2026 Year 11 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071561
Disclaimer: Curated by HT Syndication.
