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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033792
Receipt No. 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

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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
Email 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/
Email JBalanova@gnicpm.ru

Sponsor
Institute Federal State Institution <National Medical Research Center for Preventive Medicine> of the Ministry of Healthcare of the Russian Federation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038550

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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