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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001117
Receipt No. R000001346
Scientific Title Effect of an oral health promotion program on lifestyle modification: a worksite intervention trial
Date of disclosure of the study information 2008/04/09
Last modified on 2010/06/04

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Basic information
Public title Effect of an oral health promotion program on lifestyle modification: a worksite intervention trial
Acronym Effect of an oral health promotion program on lifestyle modification
Scientific Title Effect of an oral health promotion program on lifestyle modification: a worksite intervention trial
Scientific Title:Acronym Effect of an oral health promotion program on lifestyle modification
Region
Japan

Condition
Condition Metabolic syndrome
Periodontal disease
Classification by specialty
Medicine in general Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect of an oral worksite health promotion program on lifestyle factors and biomarkers related to metabolic syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of biomarkers related to metabolic syndrome at 1st year after.
Key secondary outcomes Change of lifestyle factors and oral conditions at 1st year after.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1 General oral hygiene education in subgroups of 10 persons.
2 A face-to-face instruction on appropriate tooth brushing and the use of dental floss, inter-dental brush, and fluoride-containing mouthwash.
3 Correspondence for continuous self-care, including dietary modification and quitting smoking.
4 A regular delivery of tools for oral care.
Interventions/Control_2 Usual healthcare
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1 Respondents to a questionnaire survey.
2 Pre-existing peer groups are selected following the decision by corporate staff, and all the members are recruited to an intervention group.
Key exclusion criteria 1 Persons without response to a questionnaire survey.
2 Persons who have intension not to participate in an intervention program.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Ide
Organization University of Occupational and Environmental Health, Japan
Division name Department of Work Systems and Health, Institute of Industrial Ecological Sciences
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL 093-603-1611
Email

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Ide
Organization University of Occupational and Environmental Health, Japan
Division name Department of Work Systems and Health, Institute of Industrial Ecological Sciences
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL 093-603-1611
Homepage URL
Email r-ochide@med.uoeh-u.ac.jp

Sponsor
Institute Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 04 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no significant difference between the intervention and control groups in health examination components at both baseline and 1-year.
There was significant difference between the two groups in total score of oral health-related quality of life (OHRQoL) measurement, functional limitation subscale, and disability and handicap subscale, indicating that the intervention group had better OHRQoL. 
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 Completed
Date of protocol fixation
2008 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 01 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 09 Day
Last modified on
2010 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001346

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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