UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015860 |
|---|---|
| Receipt number | R000018455 |
| Scientific Title | Validation of Efficiency of the Preventive Program in Individuals with Pre-Diabetes Mellitus: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2015/07/09 17:21:22 |
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Basic information
Public title
Validation of Efficiency of the Preventive Program in Individuals with Pre-Diabetes Mellitus: A Randomized Controlled Trial
Acronym
Validation of Efficiency of the Preventive Program in Individuals with Pre-Diabetes Mellitus: A Randomized Controlled Trial
Scientific Title
Validation of Efficiency of the Preventive Program in Individuals with Pre-Diabetes Mellitus: A Randomized Controlled Trial
Scientific Title:Acronym
Validation of Efficiency of the Preventive Program in Individuals with Pre-Diabetes Mellitus: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Pre-Diabetes Mellitus and Obesity
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compere the body weight change in three months between the e-learning group using the preventive intervention program for Pre-Diabetes Mellitus and obesity, and the non e-learning group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the body weight change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
With the e-learning program which is provided by the application of smartphone
Interventions/Control_2
Without the e-learning program which is provided by the application of smartphone
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) HbA1c level 6.0 - 6.8 %
2) the body mass index more than 25kg/m2
Key exclusion criteria
1) Patient who is in treatment or take medicine for diabetes
2) Individual who doesn't live in the suburbs of Tokyo and Osaka
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moritani Toshio |
Organization
Graduate school of Human and Environmental Studies, Kyoto University
Division name
Department of Cognitive of Behavioral Sciences
Zip code
Address
Yoshida-Nihonmatsu-cho, Sakyo-ku, Kyoto
TEL
075-865-0214
ebh@ebh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akata Saki |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Health Informatics
Zip code
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-7531
Homepage URL
akata.saki.53u@st.kyoto-u.ac.jp
Sponsor or person
Institute
EBH Co.Ltd
Life Care Partners Co.Ltd
Institute
Department
Personal name
Funding Source
Organization
Life Care Partners Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
| 2014 | Year | 12 | Month | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018455
