UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019718 |
|---|---|
| Receipt number | R000022739 |
| Scientific Title | Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare business |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/02/15 18:24:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare business
Acronym
Development of a life style modification program to prevent severe diabetes by introducing a psychological approach
Scientific Title
Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare business
Scientific Title:Acronym
Development of a life style modification program to prevent severe diabetes by introducing a psychological approach
Region
| Japan |
Condition
Condition
Diabetes, Prediabetes, Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We intend to prove that application of a psychological approach to a life style modification program, which is conducted at work places that do not have their own medical facilities, would contribute to prevent an onset/progression of diabetes and a progression of obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c (Baseline and 3 and 9 months after starting intervention)
Key secondary outcomes
The degree of achieving the goal of life style modification
Anti-diabetic drug usage
Body weight
BMI
Waist circumference
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 considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Monthly Counseling for Life Style Modification (3 months)
Monthly counseling for life style modification + EQ Enhancement Training (3 months)
EQ Enhancement Training (3 months)
Interventions/Control_2
Monthly Counseling for Life Style Modification (3 months)
Monthly Counseling for Life Style Modification (3 months)
Observation without intervention (3 months)
Interventions/Control_3
Monthly Counseling for Life Style Modification (3 months)
Monthly counseling for life style modification + EQ Enhancement Training (6 months)
Interventions/Control_4
Monthly Counseling for Life Style Modification (3 months)
Monthly counseling for life style modification (6 months)
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
Diabetic/Prediabetic patients or obese individuals in entities with employees participating in a study, entitled 'A cohort study to reveal factors that contribute to the onset of diabetes/metabolic syndrome through a development of insulin resistance' or in health insurance union of Awa Bank, Limited, Tokushima Bank, Limited or Otsuka Pharmaceutical Co, Ltd.
Diabetic patients are defined as individuals with FBS >= 126 mg/dl or HbA1c >= 6.5%, or individuals treated with anti-diabetic medication due to a diagnosis of diabetes. Prediabetic patients are defined as individuals with HbA1c >= 6.1% and < 6.5%. Obesity is defined as BMI >= 25.
Key exclusion criteria
1. Individuals without written consents
2. Individuals with HbA1c >= 8.4%, or 2 hour post prandial glucose >= 220 mg/dl
3. Individuals with fundal hemorrhage. Individuals diagnosed with preproliferative or proliferative retinopathy, who are at risk of fundal hemorrhage. Individuals who have not consulted ophthalmologists despite of a presence of simple retinopathy.
4. Individuals with Stage 3 or higher diabetic nephlopathy
5. Individuals with a past history of severe cardiovascular events, such as cardiac infarction, or individuals who have been pointed out with abnormalities in their cardiovascular system at medical checkups
6. Individuals with diabetic autonomic neuropathy
7. Individuals with extremely poor metabolism (FBS >= 250 mg/dl or moderate or higher level of keton in urine)
8. Individuals with acute infection
9. Individuals with severe HT (Systolic BP >= 180 mmHg or Diastolic BP >=110 mmHg)
10. Individuals with orthopedic problems, such as bone/joint diseases
11. Individuals with diabetic gangrene
12. Individuals with exercise restriction by a doctor in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetada Hamao |
Organization
Tokushima Data Service Co. Ltd.
Division name
President & CEO
Zip code
Address
3-55 Saiwai-cho Tokushima Japan
TEL
088-622-6188
shigetada.h@tec-inf.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kanazawa |
Organization
Tokushima Data Service Co. Ltd.
Division name
Operating Officer
Zip code
Address
3-55 Saiwai-cho Tokushima Japan
TEL
088-622-6188
Homepage URL
t.kanazawa@tds-inf.co.jp
Sponsor or person
Institute
Tokushima Data Service Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Tokushima Data Service Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Clinical Research Center for Diabetes, Tokushima University Hospital
Name of secondary funder(s)
The Small and Medium Enterprise Agency
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
株式会社徳島データサービス(徳島県)
徳島大学病院(徳島県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
