UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022978 |
|---|---|
| Receipt number | R000026481 |
| Scientific Title | Intervention study on children's health issues after the Great East Japan Earthquake |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2020/07/04 12:28:01 |
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Basic information
Public title
Intervention study on children's health issues after the Great East Japan Earthquake
Acronym
Intervention study after the Great East Japan Earthquake
Scientific Title
Intervention study on children's health issues after the Great East Japan Earthquake
Scientific Title:Acronym
Intervention study after the Great East Japan Earthquake
Region
| Japan |
Condition
Condition
over weight / obesity
bronchial asthma / allergic dermatitis
Classification by specialty
| Pediatrics | Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve children's health in the affected area, we establish effective interventional methods for addressing children's health issues after the Great East Japan Earthquake,
Basic objectives2
Others
Basic objectives -Others
We target elementary schoold children in Ishinomaki City and conduct a survey and interventions.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Weight, BMI, amount of activity, QOL before and after intervention.
2) quantity of antigen (fungus and ticks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention period: 3 months a year
measurement of body weight(daily)
Restriction o beverage, such as juice or milk (daily)
nutritional guidance (2-3 times)
exercise guidance(2-3 times)
Interventions/Control_2
Intervention period: 2 months a year
environmental arrangement guidance
Interventions/Control_3
Intervention period: 3 months a year
workshop(2-3 times)
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who are living in Ishinomaki City at the time of survey
Children whose parent agree to participate in the study
Key exclusion criteria
Children who are absent from school for long periods
Children whose parent do not consent to participate in the study
Target sample size
1140
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Kure |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7284
kure@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kuriyama |
Organization
International Institute of Disaster Science, Tohoku University
Division name
Disaster-related Public Health
Zip code
980-8573
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-274-6091
Homepage URL
kuriyama@med.tohoku.ac.jp
Sponsor or person
Institute
Disaster-related Public Health
International Institute of Disaster Science, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8006
med-kenkyo@grp.tohoku.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
| 2016 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://research-er.jp/projects/view/998404/1026116
Publication of results
Published
Result
URL related to results and publications
https://research-er.jp/projects/view/998404/1026116
Number of participants that the trial has enrolled
300
Results
1) Individual interventions were useful for weight reduction. 2)Environmental cares were useful for allergic symptoms. 3) Parental environmental factors such as parental attitudes, parental mental health, and social capital were associated with delayed or sustained problem behavior.
Results date posted
| 2020 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See 'Results'
Participant flow
See 'Results'
Adverse events
none
Outcome measures
Obesity, allergy, mental health
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026481
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
