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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039896
Receipt No. R000045502
Scientific Title Remote Monitoring of Body Weight - RJ-Region multicenter Russian-Japanese project
Date of disclosure of the study information 2021/05/24
Last modified on 2021/05/25

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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

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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