UMIN-CTR Clinical Trial

Basic information
Public title	Remote Monitoring of Body Weight - RJ-Region multicenter Russian-Japanese project
Acronym	RJ-Region Project
Scientific Title	Remote Monitoring of Body Weight - RJ-Region multicenter Russian-Japanese project
Scientific Title:Acronym	RJ-Region Project
Region	Europe

Condition
Condition	Men and women aged 18 -60 years old with overweight/obesity (BMI 27-37 kg/m2(inclusive).
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of Japanese preventive technology adapted to domestic health conditionsand aimed at reducing overweight and obesity based on personalized preventive counseling and remote control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reducing overweight and obesity(by 3-5 %)from baseline body mass during 3-6 month follow up
Key secondary outcomes	waist circumference (cm), body mass index (kg/m2), blood pressure level (mm Hg)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
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 mobile applicationandduring 2 interim visits): The analysis of the participants`remotely transmitted data, nutrition diary, blood pressure level, weight and dataphysical activity leve. Support / behavior correction, taking into account the acquired data on nutrition, self-monitoring devices
Interventions/Control_2	Low intensity intervention 1) Using self-monitoring devices (scales, blood pressure monitor, fitness-tracker) 2) Weekly monitoring and support (by mobile application only): The analysis of the participants`remotely transmitted data: nutrition diary, blood pressure level, weight and physical activity level.Support / behavior correction, taking into account the acquired data on nutrition, self-monitoring
Interventions/Control_3
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Men and women aged 18 -60 years old with overweight/obesity (BMI 27-37 kg/m2). Signedinformed consent. Internet access and a personal smartphone with Android operating system version 4.0 and higher. Signed documents on acceptance and obligation to return all handed devices at the end of the project.
Key exclusion criteria	Verified CAD. AH of the 3 degree. AVCC, TIA in history. Type 1 and type 2 diabetes. Oncological disease. Chronic heart failure III-IV functional class, according to NYHA classification Hyperthyroidism, hypothyroidism. Mental diseases. Chronic alcoholism Implanted medical electronic devices(pacemaker). Bariatric surgery history. Taking medications that can affect body weight changes. Pregnancy Frequent or long-term business trips/vacations during the planned period of follow-up.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Anna Middle name V Last name Kontsevaya
Organization	Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Division name	Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System
Zip code	101990
Address	Petroverigskii per., 10, Moscow, Russia
TEL	+7(495)7907177
Email	AKontsevaya@gnicpm.ru

Public contact
Name of contact person	1st name Boris Middle name E Last name Gornyy
Organization	Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Division name	Department of Primary Prevention of Chronic Non-Communicable Diseases in the Healthcare System
Zip code	101990
Address	Petroverigskii per., 10, Moscow, Russia
TEL	+7(495)7907177
Homepage URL	http://www.gnicpm.ru
Email	bgornyy@gnicpm.ru

Sponsor
Institute	Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Institute
Department

Funding Source
Organization	Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Russia

Other related organizations
Co-sponsor	Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation ShigaUniversityofMedicalScience National Cerebral and Cardiovascular Center
Name of secondary funder(s)	MHLW(Japan)

IRB Contact (For public release)
Organization	Federal State Institution National Medical Research Center for Terapy and Preventive Medicine
Address	Petroverigskii per., 10, Moscow, Russia
Tel	+7(499)553-67-77
Email	AKontsevaya@gnicpm.ru

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

Health Center of the Medical Prevention Center(Orenburg Region); College of Medicine + Offices of general medical practice (Sverdlovsk Region); Department for medical prevention of City Clinic (Tyumen Region); Central Clinical Medical Unit + Health Center of the Medical Prevention Center + Regional Clinical Hospital (Ulyanovsk Region); Medical Prevention Center(Yamal-Nenets Autonomous District); Clinic of Tver State Medical University + Medical Prevention Center(Tver Region).

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 24 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	2020 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 21 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045502