UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026607