UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037004 |
|---|---|
| Receipt number | R000042159 |
| Scientific Title | Health promotion of workers by a behavior change program and a psychotherapy |
| Date of disclosure of the study information | 2019/06/09 |
| Last modified on | 2023/12/19 12:26:02 |
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Basic information
Public title
Health promotion of workers by a behavior change program and a psychotherapy
Acronym
Ishinomaki HP Study
Scientific Title
Health promotion of workers by a behavior change program and a psychotherapy
Scientific Title:Acronym
Ishinomaki HP Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine health-promoting effects of a behavior change program combined with a short term psychotherapy "autonomy training" by a randomised controlled trial in an association workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in five lifestyles
Key secondary outcomes
Change in an "autonomous" behavior pattern
Change in quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A behavior change program combining two components:
- A feedback system of individual cancer risk
- A lifestyle promoting program
Interventions/Control_2
Intervention 1 plus psychotherapy "Autonomy Training":
- A personal interview of one to three hours per time
- One- to three-time interviews for one member of intervention group
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Competence of smooth communication in Japanese and answering self-administered questionnaires
Having one or more items to be improved among the five lifestyles including smoking, alcohol-drinking, diet, physical activity, and body weight
Key exclusion criteria
History of cancer
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nagano |
Organization
Center for Health Sciences and Counseling, Kyushu University
Division name
Division of Health Sciences
Zip code
819-0395
Address
744 Motooka, Nishiku, Fukuoka
TEL
092-802-5118
nagano@chc.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Rimi |
| Middle name | |
| Last name | Nishimura |
Organization
Center for Health Sciences and Counseling, Kyushu University
Division name
Division of Health Sciences
Zip code
819-0395
Address
744 Motooka, Nishiku, Fukuoka
TEL
092-802-5118
Homepage URL
rimi-n@chc.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Japanese Red Cross Ishinomaki Hospital
Address
Nishimichishita-71 Hebita, Ishinomaki-shi, Miyagi-ken
Tel
0225-21-7220
i-hosp@ishinomaki.jrc.or.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
| 2019 | Year | 06 | Month | 09 | 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
142
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Supplemental recruitment in preparation.
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042159
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
