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

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 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


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

Value
https://center6.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