UMIN-CTR Clinical Trial

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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