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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023087
Receipt No. 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 2020/01/10

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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
Email 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
Email adachi@nutrisupport.co.jp

Sponsor
Institute Teikyo University, Graduate School of Public Health
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026607

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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