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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000164
Receipt No. 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

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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
Email

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
Email aokayama@hsp.ncvc.go.jp

Sponsor
Institute HPDP research group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000233

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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