UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000164 |
|---|---|
| Receipt number | R000000233 |
| Scientific Title | Health Promotion Program for Piabetes prevention (HPDP) |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2005/09/12 11:05:04 |
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Basic information
Public title
Health Promotion Program for Piabetes prevention (HPDP)
Acronym
HPDP study
Scientific Title
Health Promotion Program for Piabetes prevention (HPDP)
Scientific Title:Acronym
HPDP study
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal effect of a health education program conducted by health professionals on long term prevention for diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of diabetes
Key secondary outcomes
Weight control, physical activity,dietary habits
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Long term prevention progaram based on a incentive model after 6 month intensive health education program.
Interventions/Control_2
The self control after a 6 month intensitve health education program.
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
(fasting blood sugar < 126 mg/dl
and >109 mg/dl at screening)
and
(fasting blood sugar <126 mg/dl and >94 mg/dl at baseline)
Key exclusion criteria
drug treatment of diabetes
past history of coronary heart disease
Past history of stroke
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Okayama |
Organization
National Cardiovascular Center
Division name
Preventive cardiology
Zip code
Address
Hujishirodai 5-7-1, suita,Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Okayama |
Organization
National Cardiovascular Center
Division name
Preventive cardiology
Zip code
Address
Hujishirodai 5-7-1, suita,Japan
TEL
06-6833-5012
Homepage URL
aokayama@hsp.ncvc.go.jp
Sponsor or person
Institute
HPDP research group
Institute
Department
Personal name
Funding Source
Organization
Reasearch Grants from the Ministry of Health, Labor and Welfare(H14-16),
a Grant-in-Aid for Scientific Research (H17-H19)
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
| 2005 | Year | 10 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2003 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2005 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000233
