UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033792 |
|---|---|
| Receipt number | R000038550 |
| Scientific Title | Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI) |
| Date of disclosure of the study information | 2018/08/18 |
| Last modified on | 2018/08/17 14:06:32 |
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Basic information
Public title
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
Acronym
RJ-TOMODACHI Project
Scientific Title
Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
Scientific Title:Acronym
RJ-TOMODACHI Project
Region
| Europe |
Condition
Condition
Men and women aged 25-60 years old with overweight/obesity (BMI 27-37 kg/m2)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
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
Interventions/Control_2
Low intensity intervention
Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker)
Interventions/Control_3
Standard care group
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Boris Gornyi (Russia), Kazuyo Tsushita (Japan) |
Organization
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation(Russia), Aichi Health Promotion Public Interest Foundation(Japan)
Division name
Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System (Russia), Comprehensive Health Science Center (Japan)
Zip code
Address
Petroverigskii per.,10, Moscow, 101990 Russia (Russia), Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan (Japan)
TEL
+7(495)7907172
BGornyy@gnicpm.ru
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yulia Balanova |
Organization
<National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare (Russia)
Division name
Department of Epidemiology of Chronic Non-Communicable Diseases
Zip code
Address
Petroverigskii per.,10, Moscow, 101990 Russia
TEL
+7(495)7907172
Homepage URL
https://www.gnicpm.ru/
JBalanova@gnicpm.ru
Sponsor or person
Institute
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
Institute
Department
Personal name
Funding Source
Organization
Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Russian Federation
Other related organizations
Co-sponsor
Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation
Shiga University of Medical Science
National Cerebral and Cardiovascular Center
Name of secondary funder(s)
Ministry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
Address
Tel
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
The methodical center of multifactorial prophylaxis of the Institution "National Medical Research Center for Preventive Medicine" of the Ministry of Health of Russia
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038550
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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