UMIN試験ID | UMIN000033792 |
---|---|
受付番号 | R000038550 |
科学的試験名 | Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI) |
一般公開日(本登録希望日) | 2018/08/18 |
最終更新日 | 2018/08/17 14:06:32 |
日本語
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
英語
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
日本語
RJ-TOMODACHI Project
英語
RJ-TOMODACHI Project
日本語
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
英語
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
日本語
RJ-TOMODACHI Project
英語
RJ-TOMODACHI Project
欧州/Europe |
日本語
Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2)
英語
Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2)
内分泌・代謝病内科学/Endocrinology and Metabolism |
悪性腫瘍以外/Others
いいえ/NO
日本語
To evaluate the effectiveness of a comprehensive program to reduce excess body weight with the inclusion of Japanese preventive technology of remote monitoring compared with dietary counseling.
英語
To evaluate the effectiveness of a comprehensive program to reduce excess body weight with the inclusion of Japanese preventive technology of remote monitoring compared with dietary counseling.
有効性/Efficacy
日本語
英語
探索的/Exploratory
実務的/Pragmatic
該当せず/Not applicable
日本語
To evaluate the effectiveness of a comprehensive program to reduce excess body weight (by 3-5%) with the inclusion of Japanese preventive technology of remote monitoring compared with dietary counseling.
英語
To evaluate the effectiveness of a comprehensive program to reduce excess body weight (by 3-5%) with the inclusion of Japanese preventive technology of remote monitoring compared with dietary counseling.
日本語
Physical examinations: measurement of blood pressure (BP), heart rate, anthropometric measurements such as height, weight, waist circumference, consultation with a therapist or cardiologist.
Laboratory parameters in the blood and Urine: Complete blood count: Hemoglobin, Erythrocytes, Color index, Leukocytes, erythrocyte sedimentation rate.
Urine analysis: Protein, Glucose, Ketones.
Lipid profile: Total cholesterol, VLDL Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides.
Biochemical analysis of blood: Plasma glucose, fasting Glycated hemoglobin, Creatinine, Uric acid, Total protein, ALT, AST, TSH.
英語
Physical examinations: measurement of blood pressure (BP), heart rate, anthropometric measurements such as height, weight, waist circumference, consultation with a therapist or cardiologist.
Laboratory parameters in the blood and Urine: Complete blood count: Hemoglobin, Erythrocytes, Color index, Leukocytes, erythrocyte sedimentation rate.
Urine analysis: Protein, Glucose, Ketones.
Lipid profile: Total cholesterol, VLDL Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides.
Biochemical analysis of blood: Plasma glucose, fasting Glycated hemoglobin, Creatinine, Uric acid, Total protein, ALT, AST, TSH.
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープン/Open -no one is blinded
実薬・標準治療対照/Active
いいえ/NO
いいえ/NO
中央登録/Central registration
3
治療・ケア/Treatment
医療器具・機器/Device,equipment | 行動・習慣/Behavior,custom |
日本語
High Intensity intervention
1)Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
2)Weekly monitoring and support (by phone, at visit, by e-mail, by messenger): The analysis of the sent nutrition diary of a food, blood pressure, weight and fitness-tracker data, of the participant of research. Support/behavior correction, taking into account the acquired data on nutrition, self-monitoring devices
英語
High Intensity intervention
1)Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
2)Weekly monitoring and support (by phone, at visit, by e-mail, by messenger): The analysis of the sent nutrition diary of a food, blood pressure, weight and fitness-tracker data, of the participant of research. Support/behavior correction, taking into account the acquired data on nutrition, self-monitoring devices
日本語
Low intensity intervention
Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
英語
Low intensity intervention
Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
日本語
Standard care group
英語
Standard care group
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
25 | 歳/years-old | 以上/<= |
60 | 歳/years-old | 未満/> |
男女両方/Male and Female
日本語
1. Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2).
2. Accommodation in Moscow and Moscow region.
3. Signing of informed consent.
4. Availability of Internet access (use of e-mail).
5. Use of mobile (cellular) communication.
英語
1. Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2).
2. Accommodation in Moscow and Moscow region.
3. Signing of informed consent.
4. Availability of Internet access (use of e-mail).
5. Use of mobile (cellular) communication.
日本語
1. Verified CAD.
2. AH of the 3 degree.
3. AVCC, TIA in history.
4. Chronic diseases in the acute stage, acute diseases.
5. Diseases requiring a special diet.
6. Type 1 and type 2 diabetes.
7. Oncological disease.
8. Chronic heart failure "II-IV", according to NYHA classification
9. Hyperthyroidism, hypothyroidism.
10. Mental diseases.
11. Disability groups for any disease.
12. Availability of medical electronic implants (pacemaker).
13. Bariatric surgery history.
14. Taking medications that can affect body weight changes (a 12).
15. Frequent business trips (more than 28 days in 6 months).
16. Night work/ daily work schedule
英語
1. Verified CAD.
2. AH of the 3 degree.
3. AVCC, TIA in history.
4. Chronic diseases in the acute stage, acute diseases.
5. Diseases requiring a special diet.
6. Type 1 and type 2 diabetes.
7. Oncological disease.
8. Chronic heart failure "II-IV", according to NYHA classification
9. Hyperthyroidism, hypothyroidism.
10. Mental diseases.
11. Disability groups for any disease.
12. Availability of medical electronic implants (pacemaker).
13. Bariatric surgery history.
14. Taking medications that can affect body weight changes (a 12).
15. Frequent business trips (more than 28 days in 6 months).
16. Night work/ daily work schedule
200
日本語
名 | |
ミドルネーム | |
姓 | Boris Gornyi (Russia), Kazuyo Tsushita (Japan) |
英語
名 | |
ミドルネーム | |
姓 | Boris Gornyi (Russia), Kazuyo Tsushita (Japan) |
日本語
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation(Russia), Aichi Health Promotion Public Interest Foundation(Japan)
英語
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation(Russia), Aichi Health Promotion Public Interest Foundation(Japan)
日本語
Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System (Russia), Comprehensive Health Science Center (Japan)
英語
Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System (Russia), Comprehensive Health Science Center (Japan)
日本語
Petroverigskii per.,10, Moscow, 101990 Russia (Russia), Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan (Japan)
英語
Petroverigskii per.,10, Moscow, 101990 Russia (Russia), Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan (Japan)
+7(495)7907172
BGornyy@gnicpm.ru
日本語
名 | |
ミドルネーム | |
姓 | Yulia Balanova |
英語
名 | |
ミドルネーム | |
姓 | Yulia Balanova |
日本語
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare (Russia)
英語
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare (Russia)
日本語
Department of Epidemiology of Chronic Non-Communicable Diseases
英語
Department of Epidemiology of Chronic Non-Communicable Diseases
日本語
Petroverigskii per.,10, Moscow, 101990 Russia
英語
Petroverigskii per.,10, Moscow, 101990 Russia
+7(495)7907172
https://www.gnicpm.ru/
JBalanova@gnicpm.ru
日本語
その他
英語
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
日本語
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
日本語
日本語
英語
日本語
その他
英語
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
日本語
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
日本語
海外/Outside Japan
日本語
Russian Federation
英語
Russian Federation
日本語
Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation
Shiga University of Medical Science
National Cerebral and Cardiovascular Center
英語
Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation
Shiga University of Medical Science
National Cerebral and Cardiovascular Center
日本語
Ministry of Health, Labour and Welfare
英語
Ministry of Health, Labour and Welfare
日本語
英語
日本語
英語
いいえ/NO
日本語
英語
日本語
英語
The methodical center of multifactorial prophylaxis of the Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Health of Russia
2018 | 年 | 08 | 月 | 18 | 日 |
未公表/Unpublished
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
開始前/Preinitiation
2018 | 年 | 06 | 月 | 09 | 日 |
2018 | 年 | 09 | 月 | 01 | 日 |
日本語
英語
2018 | 年 | 08 | 月 | 17 | 日 |
2018 | 年 | 08 | 月 | 17 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038550
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038550
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