UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058154 |
|---|---|
| Receipt number | R000066471 |
| Scientific Title | Adjunct study of 8-year-old participants in the Japan Environment and Children's Study |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/12 10:00:23 |
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Basic information
Public title
Adjunct study of 8-year-old participants in the Japan Environment and Children's Study
Acronym
JECS-8 Adjunct study
Scientific Title
Adjunct study of 8-year-old participants in the Japan Environment and Children's Study
Scientific Title:Acronym
JECS-8 Adjunct study
Region
| Japan |
Condition
Condition
Mental health, physical condition, bone density, fractures, photosensitivity
Classification by specialty
| Pediatrics | Dermatology | Psychiatry |
| Orthopedics | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the physical and mental health of mothers eight years after giving birth and the health of their children's
Basic objectives2
Others
Basic objectives -Others
Objective 1: To clarify the physical and mental health status of mothers eight years after childbirth and to investigate past and present factors related to these by linking them with data already obtained from the JECS.
Objective 2: To clarify factorial validity by conducting exploratory and confirmatory factor analysis of each question item related to postpartum depression and bonding to children.
Objective 3: To clarify lifestyle habits and health literacy that may influence bone density in premenopausal women, and to identify factors strongly associated with increased and maintained bone density.
Objective 4: To clarify the association between children's fractures and bone density, and to identify factors influencing bone density.
Objective 5: To clarify the prevalence, age of onset, and risk factors for photosensitivity in children.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpartum depression, maternal bonding to children, physical activity, body composition, bone density, fractures, health literacy, photosensitivity
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
| 7 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who attended the JECS elementary school examination (second grade).
Key exclusion criteria
People with precision mechanical devices implanted in their bodies, such as pacemakers
Target sample size
3158
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Tsuchida |
Organization
University of Toyama
Division name
Department of Public Health, Faculty of Medicine
Zip code
9300194
Address
2930 Sugitani, Toyama, Toyama, Japan
TEL
0764347277
aktsuchi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Tsuchida |
Organization
University of Toyama
Division name
Department of Public Health, Faculty of Medicine
Zip code
9300194
Address
2930 Sugitani, Toyama, Toyama, Japan
TEL
0764347277
Homepage URL
http://www.med.u-toyama.ac.jp/eco-tuc/detail/eighth/
aktsuchi@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Akiko Tsuchida
Funding Source
Organization
Internal research funds of University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2930 Sugitani, Toyama, Toyama, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.ac.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
| 2025 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
6316
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study involving noninvasive bone density measurements and questionnaire
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066471
