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 |
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients with behavior type specific approach
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials
Evaluation of the effects of lifestyle improvement for type 2 diabetes patients with behavior type specific approach
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
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.
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
Interventional
Parallel
Randomized
Cluster
Single blind -participants are blinded
Active
2
Educational,Counseling,Training
Behavior,custom |
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.
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.
20 | years-old | < |
79 | years-old | >= |
Male and Female
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.)
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
288
1st name | Kazue |
Middle name | |
Last name | Yamaoka |
Teikyo University
Graduate School of Public Health
173-8605
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
03-3964-1211
kazue@med.teikyo-u.ac.jp
1st name | Misa |
Middle name | |
Last name | Adachi |
Nutrition Support Network LLC
Research & Development Dept
252-0334
2-2-4,Wakamatsu, Sagamihara city, Kanagawa, Japan
042-765-6393
adachi@nutrisupport.co.jp
Teikyo University, Graduate School of Public Health
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
Japanese Governmental office
Center for Medical Statistics, Showa Women's University
Teikyo University
2-11-1 Kaga, Itabashi-ku, Tokyo
03-3964-1211
turb-office@teikyo-u.ac.jp
NO
日本国内の病院・診療所
2016 | Year | 07 | Month | 08 | Day |
http://bmjopen.bmj.com/content/bmjopen/7/10/e017838.full.pdf
Unpublished
73
Terminated
2016 | Year | 06 | Month | 27 | Day |
2017 | Year | 07 | Month | 06 | Day |
2018 | Year | 04 | Month | 16 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 12 | Month | 31 | Day |
2022 | Year | 06 | Month | 30 | Day |
2016 | Year | 07 | Month | 08 | Day |
2021 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026607