UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063390 |
|---|---|
| Receipt number | R000072449 |
| Scientific Title | Early to Bed, Early to Rise, and a Healthy Breakfast: A Feasibility Study of the Kodomo San-San Challenge in Preschool Children |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/10/15 15:12:32 |
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Basic information
Public title
Early to Bed, Early to Rise, and a Healthy Breakfast: A Feasibility Study of the Kodomo San-San Challenge in Preschool Children
Acronym
Early to Bed, Early to Rise, and a Healthy Breakfast: A Feasibility Study of the Kodomo San-San Challenge in Preschool Children
Scientific Title
Early to Bed, Early to Rise, and a Healthy Breakfast: A Feasibility Study of the Kodomo San-San Challenge in Preschool Children
Scientific Title:Acronym
SAN-SAN Study
Region
| Japan |
Condition
Condition
Children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The SAN-SAN Study aims to evaluate changes in lifestyle habits among preschool children in Kato City before and after participation in the Kodomo San-San Challenge and to assess the feasibility and effectiveness of this initiative in improving lifestyle habits. Specifically, the study will examine changes in bedtime, wake-up time, sleep duration, breakfast consumption, and breakfast composition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to examine changes in bedtime, wake-up time, sleep duration, breakfast consumption, and breakfast composition.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 4 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Attending a certified early childhood education and care center, nursery school, or kindergarten in Kato City
Preschool-aged children
Key exclusion criteria
Children whose parents or guardians did not provide consent for participation in the study
Children otherwise deemed unsuitable for participation by the principal investigator
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sakane |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
0756419161
404-j-doit1@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Suganuma |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
6128555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
0756419161
Homepage URL
404-j-doit1@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
AKIKO SUGANUMA
Funding Source
Organization
KAKENNHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto-shi, Kyoto
Tel
0756419161
404-j-doit1@mail.hosp.go.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
| 2026 | Year | 10 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072449
