UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tackle Obesity and Metabolic syndrome Outcome by Diet, Activities and Checking BW Intervention (RJ-TOMODACHI)
Title of the study (Brief title)	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	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)
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	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
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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