UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010833 |
|---|---|
| Receipt number | R000012686 |
| Scientific Title | Intervention for environmental tobacco smoke avoidance in junior high school students and allergic diseases |
| Date of disclosure of the study information | 2013/05/29 |
| Last modified on | 2021/01/11 16:19:20 |
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Basic information
Public title
Intervention for environmental tobacco smoke avoidance in junior high school students and allergic diseases
Acronym
Intervention for environmental tobacco smoke avoidance and allergic diseases
Scientific Title
Intervention for environmental tobacco smoke avoidance in junior high school students and allergic diseases
Scientific Title:Acronym
Intervention for environmental tobacco smoke avoidance and allergic diseases
Region
| Japan |
Condition
Condition
environmental tobacco exposure
asthma, allergic rhinitis, Japanese cedar pollinosis
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of educational intervention for environmental tobacco smoke exposure in junior high school students in relation to allergic diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Decrease in urinary cotinine levels after educational intervention for environmental tobacco smoke exposure.
Key secondary outcomes
Prevalence and severity of allergic diseases and environmental tobacco exposure
Lung functions and environmental tobacco expusre
Improvemento of attitude toward smoking after educational intervention for environmental tobacco smoke exposure.
Experience of smoking before 20 years of age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The education will be provided in 3 junior high school. The education in classified into 10 different topics, and each topic is taught for 10 minutes. Each topic includes sound- and print-based educational materials.
Interventions/Control_2
No education will be provided in 2 control schools, and educational materials will be provided after re-evaluation of urinary cotinine and questionnaire.
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
| 12 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Junior high school students at Yotsukaido municipal schools who agree to participate in the study with a written informed consent.
Key exclusion criteria
Students with severe development disorder or visual and hearing disabilities
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Suzuki |
Organization
Shimoshizu National Hospital
Division name
Department of Pediatrics
Zip code
284-0003
Address
Yotsukaido
TEL
0434222511
seeyou@msj.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Suzuki |
Organization
Shimoshizu National Hospital
Division name
Department of Pediatrics
Zip code
284-0003
Address
Yotsukaido
TEL
0434222511
Homepage URL
https://www.nsh.gr.jp/
seeyou@msj.biglobe.ne.jp
Sponsor or person
Institute
Shimoshizu National Hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
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
Shimoshizu National Hospital
Address
934-5 Shikawatashi Yotsukaido, Chiba
Tel
0434222511
seeyou@msj.biglobe.ne.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
| 2013 | Year | 05 | Month | 29 | 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
700
Results
After educational intervention, urinary cotinine levels were decreased significantly in both groups. In highly exposed group (>5ng/mg creatinine), the frequency of improvement was higher in intervention group significantly. The intervention was significantly associated with cotinine reduction after adjustment by paternal education. In intervention group, students who completely understood how to avoid environmental tobacco exposure showed higher frequency of reduction of urinary cotinine after intervention.
Results date posted
| 2021 | Year | 01 | Month | 11 | Day |
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
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since analysis of primary outcome has been completed, we will submit for a medical journal by the end of 2018.
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012686
| Research Plan | |
|---|---|
| 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 |
