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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042897
Receipt No. R000048967
Scientific Title Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Date of disclosure of the study information 2021/01/04
Last modified on 2021/01/04

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Basic information
Public title Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Acronym Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Scientific Title:Acronym Study on effects of "online education and life improvement program for diabetic patients" on behavior change, biochemical parameter, and related factors.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to build a program that brings change to one's behavior.
The program will refer to in-hospital diabetes educational program, and designed to be safe (not to worsen the patient's condition) under the direction of a doctor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
weight
BMI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Provide online educational program for a week, and observe their change for 4 weeks after the program.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Diabetic patients of the University of Tsukuba Hospital
2) Patients whose HbA1c is more than 7.0 % and less than 7.9 %
3) Males and females aged between 20 and 65 at the start of this clinical trial
4) Patients who are not taking sulfonylureas or injecting insulin at the start of this clinical trial
5) Patients who can walk about 6,000 steps a day
6) Patients who have difficulty in normal education hospitalization
7) Patients whose doctor permits the entry of this stud
Key exclusion criteria 1) Patients with severe infections, before or after operations or having serious external injuries at the time of agreement acquisition
2) Patients with exercise restrictions
3) Pregnant women, lactating women, or women who have possibility of pregnancy
4) Patients who are judged to be inappropriate by the research managers
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Yahagi
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8575
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 029-853-3053
Email nyahagi-tky@umin.ac.jp

Public contact
Name of contact person
1st name Noya
Middle name
Last name Yahagi
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code 305-8575
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 029-853-3053
Homepage URL
Email nyahagi-tky@umin.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization JMDC Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Habitus Care Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1 Tennoundai, Tsukuba, Ibaraki
Tel 029-853-3053
Email nyahagi-tky@umin.ac.jp

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
2021 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 04 Day
Last modified on
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048967

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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