UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022978
Receipt No. 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 (Ver. 5)

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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
Email 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
Email kuriyama@med.tohoku.ac.jp

Sponsor
Institute Disaster-related Public Health
International Institute of Disaster Science, Tohoku University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026481