Public registry
Registered study
This is a registered multicentre feasibility study for which the Department of Neuropsychiatry, Kanazawa University Hospital is listed as Primary Sponsor.
- jRCT number
- jRCT1040260010
- Study title
- Feasibility Study of a Digital Companion Treatment Program for Eating Disorders Added to Standard Outpatient Care (Spoon DTx Feasibility Trial)
- First published
- 20 April 2026
- Public status
- Recruiting (jRCT status checked on 25 August 2026)
- Study design
- Interventional, single group, open label, uncontrolled
- Planned enrolment
- 20 participants
- Study sites
- Kanazawa University Hospital, Kyushu University Hospital, and Hokkaido University Hospital
- Study period
- From publication of the study plan to 31 March 2027
A Recruiting registry status does not confirm that any participant has enrolled, an intervention has started, or the app is currently being used. The software's technical status is described from separate evidence on the Product Development page.
Registered intervention
The registered 12-week plan
The jRCT record describes 12-week use of Spoon DTx in addition to standard outpatient psychiatric care.
Registered patient use
The protocol describes patient use of educational materials, workbook exercises, and dietary-behaviour recording. Use of a numberless scale is also included in the registered intervention.
Registered physician use
Physicians are to review patient data in the physician app and provide feedback during outpatient visits. This does not describe continuous monitoring or out-of-hours emergency response.
What the description means
These are functions and uses specified in the approved study plan. jRCT has not technically verified that the software is implemented, deployed, acceptance-tested, or already used by participants.
Registered outcomes
What the study is designed to assess
The primary outcome is the 12-week study continuation rate: the proportion of participants who complete the assessment visit after 12 weeks.
Feasibility
Consent, enrolment, visit and questionnaire completion, missing data, weight measurement, dietary records, programme completion, physician-app review, and reasons for discontinuation.
Safety
Occurrence of adverse events and serious adverse events.
Clinical measures
Changes in questionnaires, weight, BMI, and other clinical measures specified in the registry.
Usability and acceptability
SUS, CSQ-8J, subjective change, and willingness to continue, among other registered measures.
Registration of an outcome does not mean that a favourable result has been obtained. This page presents no study results.
Development roadmap
A staged development approach
We separate the publicly registered research stage from ViveSpoon's forward-looking development work.
1. Registered study
Publicly verifiable: a multicentre feasibility study is listed as Recruiting in jRCT.
2. Evidence and operation
Study-plan stage: the protocol is designed to assess continuation, feasibility, safety, usability, and related measures.
3. Quality, regulation, and security
Company development direction: ViveSpoon is preparing quality management, regulatory planning, security, and healthcare-delivery foundations in stages.
4. Future healthcare implementation
Future stage: implementation in healthcare would be considered only after the required evaluation and regulatory steps. No product is currently available to the general public.
Claim boundary
What the registry does not establish
- Established clinical efficacy or safety
- Regulatory approval, certification, or notification as a medical device
- Commercial or public availability
- Completed participant enrolment, intervention, or app use
- Implemented, deployed, or technically verified research software
- That ViveSpoon Inc. is the study sponsor or owns the relevant intellectual property
jRCT is a public clinical-study registry, but its content is the registered study plan. It is not a technical audit of the software or a legal verification of ownership and company relationships.
Source
Official study record
Check the official jRCT record for the current public status and complete study details.