UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023087 |
|---|---|
| Receipt number | R000026607 |
| Scientific Title | Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2021/07/12 15:05:22 |
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Basic information
Public title
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials
Acronym
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients with behavior type specific approach
Scientific Title
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials
Scientific Title:Acronym
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients with behavior type specific approach
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to examine the effectiveness of the BETSILE program in improving lifestyle by newly adding the behavior type specific approach of the subjects to the SILE program for type 2 diabetes patients. The effectiveness of the SILE program has been already verified using the cluster randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between the two groups for the change from baseline of the HbA1c levels at six months (plus or minus 1 month) from the first counseling session.
Key secondary outcomes
The changes from baseline for BMI, FBS, LDL, HDL, TG, SBP/DBP, dietary intake(energy, fat energy ratio etc), Change of health behavior and awarness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
To conduct 6 months personal lifestyle education(SILE) for type2 daiabetes. The SILE is performed according to the procedure of Nutrition Care Management. For the period from the first counseling session (start of intervention) up to six months (plus or minus 1 month), the registered dietitian sets a total of three or more counseling sessions, first counseling session, second and third counseling sessions one month and 3 months (plus or minus 1 month) respectively after the first.
Interventions/Control_2
In this method, the behavior type specific approach is added from the first counseling session with the contents and procedure of the SILE as a base. The distinction method of the behavior type is performed with four typical questions for type classification based on the pattern analysis results using Quantification Method 3 (Hayashi), with answers of the patients who are under outpatient nutrition diet guidance to 14 assessment questions on awareness, motivation and behavior as data.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who gave a written informed consent with complete understanding, after receiving a sufficient description of the study
2. Patients above the age of 20 up to 79 years when the consent is received
3. Patients meeting the criteria of 6.5% (NGSP) or more for HbA1c
4. Patients who are yet to start the therapy based on diabetes drugs, or those who are on oral drugs and insulin injections for diabetes, and the attending physician determines that there is almost no change in the HbA1c levels.(Almost no change observed in the status means that the maximum difference in HbA1c levels over a period of 3 months was less than 0.2 points.)
Key exclusion criteria
1. Patients from whom consent cannot be obtained
2. Patients with type 1 diabetes
3. Patients with gestational diabetes
4. Diabetic retinopathy: Patients with proliferative retinopathy
5. Diabetic nephropathy: Patients with stage 3 or more
6. Patients determined by the doctor as having difficulty in filling the questionnaire
Target sample size
288
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Yamaoka |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211
kazue@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Adachi |
Organization
Nutrition Support Network LLC
Division name
Research & Development Dept
Zip code
252-0334
Address
2-2-4,Wakamatsu, Sagamihara city, Kanagawa, Japan
TEL
042-765-6393
Homepage URL
adachi@nutrisupport.co.jp
Sponsor or person
Institute
Teikyo University, Graduate School of Public Health
Institute
Department
Personal name
Funding Source
Organization
1. The Ministry of Education, Culture, Sports, Science and Technology in Japan Grant-in-Aid for Scientific Research Grant C in 2017 (Grant No.17K00936)
2. Health Science Center Fundation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Medical Statistics, Showa Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3964-1211
turb-office@teikyo-u.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
日本国内の病院・診療所
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
http://bmjopen.bmj.com/content/bmjopen/7/10/e017838.full.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
73
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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026607
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