UMIN-ICDS Clinical Trial

Public title

Effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being: a fully remote randomized controlled trial

Acronym

Effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being

Scientific Title

Effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being: a fully remote randomized controlled trial

Scientific Title:Acronym

Effects of the "Well-Being YU" smartphone app on health-related quality of life and well-being

Region

Japan

Condition

N/A

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

health-related quality of life

Key secondary outcomes

Happiness, life satisfaction, WHO-5 Well-Being Index, frequency of laughter, Salt Check Sheet score, vegetable intake frequency, and physical activity (frequency and duration of walking, brisk walking, stretching, and muscle-strengthening exercises).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

64

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 sample size

400

Name of lead principal investigator

1st name	Tsuneo
Middle name
Last name	Konta

Organization

Yamagata University

Division name

Institute of Well-Being

Zip code

990-9585

Address

Iida-nishi 2-2-2, Yamagata city, Yamagata prefecture

TEL

0236285260

Email

kkonta@med.id.yamagata-u.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Seino

Organization

Yamagata University

Division name

Institute of Well-Being

Zip code

990-9585

Address

Iida-nishi 2-2-2, Yamagata city, Yamagata prefecture

TEL

0236285166

Homepage URL

Email

seino.s@med.id.yamagata-u.ac.jp

Institute

Yamagata University

Institute

Department

Personal name

Organization

Yamagata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Yamagata University School of Medicine

Address

Iida-nishi 2-2-2, Yamagata city, Yamagata prefecture

Tel

0236285047

Email

yu-ikekenkyu@jm.kj.yamagata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

山形大学（山形県）

Date of disclosure of the study information

2026

Year

08

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

07

Day

Last modified on

2026

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071561