UMIN-ICDS Clinical Trial

Public title

Encouraging campus belonging-cafe visits to improve sense of belonging in first-year university students: a randomized controlled trial

Acronym

Yocchi Cafe RCT

Scientific Title

A digitally (LINE-) delivered encouragement to visit a campus belonging cafe for disengaged first-year university students: a randomized controlled trial

Scientific Title:Acronym

BELONG-LINE Trial

Region

Japan

Condition

First-year university students at risk of social isolation, maladjustment, and disengagement (outcomes: sense of belonging and well-being)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To test whether encouraging disengaged (baseline non-user) first-year university students to visit a permanent on-campus belonging cafe improves their sense of belonging, relative to no such encouragement.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Sense of belonging, measured with the Japanese 13-item Psychological Sense of School Membership scale (PSSM-13J). Assessed at all five waves (Wave 1 = baseline, then approximately every 2 months through Wave 5). Primary endpoint: the group-by-time (linear) interaction for PSSM-13J across Waves 2 to 5, estimated with a linear mixed-effects model (intention-to-treat).

Key secondary outcomes

1) Subjective well-being (WHO-5 Well-Being Index), assessed at every wave (Waves 1 to 5). (2) Loneliness (three-item UCLA Loneliness Scale), assessed at Waves 1, 3, and 5. (3) Intention to withdraw from university (three author-created items), assessed at every wave (Waves 1 to 5). Process/mediator measure: self-reported number of cafe visits, recorded at each wave.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Invitation to a LINE official account that delivers encouragement to visit the cafe. On each cafe open day (Mondays during term), a push message notes that the cafe is open that day, timed to coincide with the opportunity to act; subsequent messages convey low-threshold ways of using the cafe (who uses it, how, and when). The intervention runs across the five-wave follow-up (approximately 8 months, around June 2026 to January 2027). The open-day announcement is fixed, while the timing and frequency of other messages are adjusted pragmatically and the messages actually delivered are logged. Survey schedule and incentives are identical across groups.

Interventions/Control_2

Invitation to a LINE official account that delivers only survey-related communications, with no encouragement to visit the cafe. Survey schedule and incentives are identical to the encouragement group.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

First-year undergraduate students enrolled at the Kanazawa-Hakkei campus of Yokohama City University who reported no prior use of the cafe (non-users) at baseline.

Key exclusion criteria

Students of the School of Medicine (based at a separate campus without practical access to the cafe). Students who reported prior cafe use at baseline (followed separately as a non-randomized reference cohort, not randomized).

Target sample size

200

Name of lead principal investigator

1st name	Koji
Middle name
Last name	Hara

Organization

Yokohama City University

Division name

School of Economics and Business Administration

Zip code

236-0027

Address

22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

0457872131

Email

hara.koj.vv@yokohama-cu.ac.jp

Name of contact person

1st name	Koji
Middle name
Last name	Hara

Organization

Yokohama City University

Division name

School of Economics and Business Administration

Zip code

2360027

Address

22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

0457872131

Homepage URL

https://osf.io/qt5bm

Email

hara.koj.vv@yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Hara Koji

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University

Address

22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan

Tel

045-787-2354

Email

sangaku@yokohama-cu.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

Date of disclosure of the study information

2026

Year

06

Month

18

Day

URL releasing protocol

https://osf.io/qt5bm

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

230

Results

Not yet available; outcome analysis has not been conducted. Results will be posted after trial completion.

Results date posted

2026

Year

06

Month

17

Day

Results Delayed

Delay expected

Results Delay Reason

Follow-up continues until around January 2027; outcome analysis will be conducted thereafter.

Date of the first journal publication of results

Baseline Characteristics

Baseline characteristics have been described for the randomized sample and the reference cohort; see the protocol (osf.io/qt5bm). Outcome results are not yet available.

Participant flow

324 registered (262 non-medical); 71 excluded; 253 eligible; 200 randomized (100 per group). Thirty existing users form the reference cohort. See the participant flow in the protocol.

Adverse events

Not applicable; minimal-risk behavioral intervention. To be reported at trial completion.

Outcome measures

Outcome results are not yet available (pre-analysis). Primary and secondary outcomes are as specified in the trial design.

Plan to share IPD

Yes; de-identified individual participant data may be shared on reasonable request to the principal investigator, within the scope of ethics approval.

IPD sharing Plan description

De-identified IPD will be shared under a data use agreement after review of a sound proposal, subject to ethics approval; timing and duration to be defined after publication.

Recruitment status

No longer recruiting

Date of protocol fixation

2026

Year

05

Month

22

Day

Date of IRB

2026

Year

05

Month

22

Day

Anticipated trial start date

2026

Year

06

Month

01

Day

Last follow-up date

2027

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This trial was registered retrospectively in this WHO primary registry (UMIN-CTR). Participant enrollment began on 1 June 2026 (first informed consent), and registry entry was made thereafter. However, the full hypotheses and the statistical analysis plan were preregistered on the Open Science Framework (osf.io/qt5bm) on 2 June 2026, before the first outcome data were collected (Wave 1, 4 June 2026). The study design is a prospective interventional RCT, not a retrospective or case-control study.

Registered date

2026

Year

06

Month

17

Day

Last modified on

2026

Year

06

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070843