UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022771 |
|---|---|
| Receipt number | R000026241 |
| Scientific Title | Intervention study to decrease the environmental exposure to tobacco smoke in children |
| Date of disclosure of the study information | 2016/06/17 |
| Last modified on | 2018/12/17 09:50:19 |
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Basic information
Public title
Intervention study to decrease the environmental exposure to tobacco smoke in children
Acronym
Intervention Study for ETS exposure in children
Scientific Title
Intervention study to decrease the environmental exposure to tobacco smoke in children
Scientific Title:Acronym
Intervention Study for ETS exposure in children
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To decrease the environmental exposure to tobacco smoke in children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cotinine concentration in urine of children
Key secondary outcomes
Questionnaire on smoking habit of the persons living with the children
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Presentation of the urinary concentration of cotinine to the parents to the intervention group. The duration of intervention si 6 months.
Interventions/Control_2
To the control group, the results of cotinine determination will not be presented. General information on smoking-related disease will be presented to the both groups.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Including person(s) who smoke in the family; Living with child younger than 12 years old; Being able to filling in questionnaire in Japanese; having a will to attend the result briefing session after the study.
Key exclusion criteria
Having smoking-related cancers such as pharyngeal, oral, lung, bronchial, esophageal,and stomach cancer; Having respiratory disease.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko NAKAI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Development and Environmental Medicine
Zip code
Address
Seiryo 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8949
nakaik@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko NAKAI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Development and Environmental Medicine
Zip code
Address
Seiryo 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8949
Homepage URL
nakaik@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Development and Environmental Medicine
Institute
Department
Personal name
Funding Source
Organization
Smoking Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学医学系研究科（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 17 | 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
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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026241
