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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041258
Receipt No. R000047091
Scientific Title A single-arm feasibility trial of workplace tobacco control programs using a workplace checklist
Date of disclosure of the study information 2020/07/30
Last modified on 2020/07/30

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Basic information
Public title Workplace interventions to promote tobacco control: a feasibility trial using a workplace checklist
Acronym Workplace interventions to promote tobacco control: a feasibility trial
Scientific Title A single-arm feasibility trial of workplace tobacco control programs using a workplace checklist
Scientific Title:Acronym A single-arm feasibility trial of workplace tobacco control programs
Region
Japan

Condition
Condition Healthy participants
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the feasibility of workplace tobacco control programs in small or medium-sized companies
Basic objectives2 Others
Basic objectives -Others Feasibility
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Employer fidelity to the checklist items at 6 months after the intervention
Key secondary outcomes - Acceptability of the intervention program: employer satisfaction at 6 months after the intervention
- Feasibility of the intervention program: number of consultations during the intervention
- Implementation outcome: implementation scores of tobacco control at 6 months after the intervention
- Process outcome: response rate of the employees survey at the baseline
- Health behavior outcomes: proportion of employees who visited smoking cessation clinics at 6 months after the intervention, proportion of employees who quit smoking at 12 months after the intervention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The interventionist will offer support to the employers and health managers to adopt and implement the following three evidence-based tobacco control measures: (1) smoke-free workplace, (2) financial assistance on smoking cessation, and (3) incentive schemes. In order to provide support tailored to the needs of the company, the interventionist will propose behavioral change techniques to the employers and health managers during the consultations based on their responses to the workplace checklist. The intervention period will be of 6 months. Consultations will be held approximately once a week in the first month followed by once every 1-3 months.
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria for companies
1) A small or medium-sized company or a branch or business office of a company, with 10 or more and 300 or fewer employees
2) Existence of a physical building, wherein the employees work
3) In business for more than 3 years
4) Assent of the employer (branch or office manager) to promote tobacco control

Inclusion criteria for intervention targets
Employers
1) The employer (branch or business manager) of the company participating in the trial

Health managers
1) Employees responsible and actually working for management and promotion of health issues at the workplace
2) The person identified by the employer as the primary health manager (in case of two or more health managers)

Inclusion criteria for observation targets
1) Adult employees aged 20 years or older
2) Employees who belong to companies that agree to participate in the trial
Key exclusion criteria None
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Taichi
Middle name
Last name Shimazu
Organization National Cancer Center, Japan
Division name Behavioral Science Division, Center for Public Health Sciences
Zip code 104-0045
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 03-3547-5201
Email tshimazu@ncc.go.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Saito
Organization National Cancer Center, Japan
Division name Behavioral Science Division, Center for Public Health Sciences
Zip code 104-0045
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 03-3547-5201(ext.3328)
Homepage URL
Email jsaito@ncc.go.jp

Sponsor
Institute National Cancer Center, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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
2020 Year 07 Month 30 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 29 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047091

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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