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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010833
Receipt No. 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 2018/05/23

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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
Middle name
Last name Shuichi Suzuki
Organization Shimoshizu National Hospital
Division name Department of Pediatrics
Zip code
Address 934-5 Shikawatashi Yotsukaido, Chiba
TEL 043-422-2511
Email seeyou@msj.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Suzuki
Organization Shimoshizu National Hospital
Division name Department of Pediatrics
Zip code
Address 934-5 Shikawatashi Yotsukaido, Chiba
TEL 043-422-2511
Homepage URL
Email seeyou@msj.biglobe.ne.jp

Sponsor
Institute Shimoshizu National Hospital
Institute
Department

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
Address
Tel
Email

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
Results
After educational intervention, urinary cotinine levels were reevaluated. In the group of the students whose family smoke, there were not a statistical difference in the cotinine level between the intervention school and the control. We will measure cotinine in another ELISA kit to confirm the data.
In June 2015, we found that the data of urinary cotinine after intervention were mishandled. In addition, measurements of some ELISA kits were obviously high in low range after re-measurement. Based on these findings, we found that urinary cotinine levels were decreased significantly in both intervention group and control group. In highly exposed group (>5ng/mg creatinie), the frequency of improvement was higher in intervention group significantly. Paternal education was another important factor associated with urinary cotinine reduction. Theintervention was significantly associated with cotinine reduciton 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
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
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
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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