UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study to decrease the environmental exposure to tobacco smoke in children
Title of the study (Brief title)	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	Kunihiko NAKAI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Development and Environmental Medicine
Address	Seiryo 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL	022-717-8949
Email	nakaik@med.tohoku.ac.jp

Public contact
Name of contact person	Kunihiko NAKAI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Development and Environmental Medicine
Address	Seiryo 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL	022-717-8949
Homepage URL
Email	nakaik@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine, Department of Development and Environmental Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026241