UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001117 |
|---|---|
| Receipt number | 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 14:50:14 |
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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
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
r-ochide@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Work Systems and Health, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
